🔍 RecallPedia

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95,089 total recalls in our database

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28,983
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17,685
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38,779
Medical Devices
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9,642
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Field Upgrade Kits: P/N 5451208 RIU, 9 INCH, TOSHIBA; P/N 5485304 SERVICE PART, IMAGE INTENSIFIER, 9 INCH, TOSHIBA; P/N 5761613 SERVICE PART, IMAGE INTENSIFIER, 9 INCH - used with OEC Flexiview 8800, OEC 9800, and OEC 9900 Systems

GE OEC Medical Systems

🏥 Medical Devices Class I - Dangerous

Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved, which may result in the image intensifier falling, which could lead to injuries such as fractures, hematoma, contusion, bruise, pain.

May 15, 2023 Infusion Pumps Nationwide View Details →

Always-On Tip Tracked Instruments (SPiN Drive instruments) 21ga ANSO Cytology Needle, 12mm L, 1.8mm OD-Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic brINS-0362onchoscopy are currently used for visualizing Model: INS-0392

Olympus Corporation of the Americas

🏥 Medical Devices Class I - Dangerous

Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could result in a potential procedural delay

May 15, 2023 Surgical Instruments Nationwide View Details →

MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)), Product Code 004225 (Suction Coagulator, Handswitching, 8 Fr, 6 inch (15.24cm), Product Code 004325 (Suction Coagulator, Handswitching, 12 Fr, 6 inch (15.24cm)), and Product Code 0041BN (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm), Bulk Non Sterile)

Megadyne Medical Products

🏥 Medical Devices Class I - Dangerous

An issue with the Suction Coagulator product family may lead to fluid ingress into the handpiece. Fluid ingress can lead to intermittent device activation, non-activation, or self-activation when plugged into the electrosurgery unit (ESU).

Jun 15, 2023 Other Medical Devices Nationwide View Details →

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. (13) STC IVC FILTER/ANGIOGRAM, Model Number: DYNJ908249A; b. 16CM 3L 7FR CVC INSERTION BUNDLE, Model Numbers: ECVC7410A; c. 16CM 7F 3L CVC MAX BARRIER INSERTION, Model Number: ECVC2205A; d. 16CM 7F CVC INSERTION TRAY, Model Number: ECVC8095; e. 16CM CVC BUNDLE W/MICROPUNCTURE KIT, Model Number: ECVC5010A; f. 16CM CVC INSERTION KIT, Model Number: ECVC6800A; g. 16CM TRIPLE LUMEN 7FR INSERT BUNDLE, Model Number: ECVC2555; h. 16CM TRIPLE LUMEN CVC INSERT BUNDLE, Model Number: ECVC4125; i. 20CM 3L 7FR CVC INSERTION BUNDLE, Model Number: ECVC5135B; j. 20CM 3L CVC INSERTION TRAY, Model Number: ECVC7325; k. 20CM 7F 3L CVC MAX BARRIER INSERTION, Model Number: ECVC1970B; l. 20CM 7F CVC INSERTION TRAY, Model Number: ECVC4335; m. 20CM CVC TRIPLE LUMEN SAFETY BUNDLE, Model Number: ECVC7160; n. 20CM TRIPLE LUMEN 7FR INSERT BUNDLE, Model Number: ECVC2560; o. 20CM, 3L INSERT BUNDLE-CINCINNATI VA, Model Number: ECVC3505; p. 2L 7FR 20CM CVC INSERTION TRAY, Model Number: ECVC7075; q. 2L 8.5FR 16CM CVC INSERTION KIT, Model Number: ECVC8055; r. 3L 7FR 16 CM CVC INSERTION TRAY, Model Number: ECVC8165; s. 3L 7FR 16CM CVC INSERTION BUNDLE, Model Numbers: ECVC4635A, ECVC7040A, ECVC7430, ECVC7475, ECVC7605, ECVC7675, ECVC8130, STCVC2055US; t. 3L 7FR 20CM CVC INSERTION BUNDLE, Model Number: ECVC7600; u. 3L 7FR 20CM CVC INSERTION BUNDLE, Model Numbers: ECVC4640A, ECVC6490A, ECVC6845, ECVC7470; v. 3L 7FR 20CM CVC INSERTION TRAY, Model Number: ECVC6170; w. 7 FR 20 CM CVC TRIPLE LUMEN BUNDLE, Model Number: ECVC3545; x. 7 FR 20CM CVC TRIPLE LUMEN BUNDLE, Model Number: ECVC2440B; y. 7F 20CM 3L CVC VANTEX BUNDLE, Model Number: ECVC7350; z. 7F, 16cm, 3L MAX BARRIER CVC BUNDLE, Model Number: ECVC5480; aa. 7F, 20CM TRIPLE LUMEN CVC BUNDLE, Model Number: ECVC3475; bb. 7FR 16 CM TRIPLE LUMEN CVC INSERTION KIT, Model Number: ECVC2770; cc. 7FR 16CM TRIPLE LUMEN CVC BUNDLE, Model Number: ECVC6370; dd. 7FR 3L 16CM CVC INSERTION BUNDLE, Model Number: ECVC7910; ee. 7FR 3L 20CM CVC INSERTION BUNDLE, Model Numbers: ECVC7235, ECVC7905; ff. 7FR TRIPLE LUMEN CVC INSERTION BUNDLE, Model Number: ECVC2795; gg. 7FR,20CM,3L ANTIMICROBIAL CVC BUNDLE, Model Number: ECVC705; hh. 8.5F 16CM 2L CVC VANTEX BUNDLE, Model Number: ECVC7355; ii. 9F AVA HF RESUSCIT CVC BNDL, Model Number: ECVC6640; jj. ABLATION EP PACK, Model Number: DYNJ43851B; kk. ABLATION PACK, Model Number: DYNJ40629C; ll. ADULT CARDIAC CATH PACK, Model Numbers: DYNJ23455K, DYNJ23455L, DYNJ23455M, DYNJ23455N; mm. ANGIO, Model Numbers: DYNJ902507C, DYNJ905151B; nn. ANGIO CATH COMBINED PACK, Model Numbers: DYNJ43609O, DYNJ43609P, DYNJ43609R, DYNJ43609S; oo. ANGIO CATH LAB PACK-LF, Model Numbers: DYNJ0313233V, DYNJ0313233W, DYNJ0313233X; pp. ANGIO CATH PACK, Model Number: DYNJ52000B; qq. ANGIO DRAPE PACK, Model Numbers: DYNJ44320G, DYNJ44320I, DYNJ44320J; rr. ANGIO DRAPE PACK (ADLUG)642-LF, Model Numbers: DYNJ47665D, DYNJ47665F; ss. ANGIO HOLLAND PACK-LF, Model Numbers: DYNJ0037936C, DYNJ0037936D; tt. ANGIO PACK, Model Numbers: DYNJ42903C, DYNJ42903D, DYNJ43661C, DYNJ44642B, DYNJ58111D, DYNJ58111F, DYNJ69200, DYNJ69951; uu. ANGIO PACK-LF, Model Number: DYNJ0407399P; vv. ANGIO SAVANNAH PACK, Model Number: DYNJ69944; ww. ANGIO TRAY, Model Number: DYNJ23438M, DYNJ52121A, DYNJ69421, DYNJ69792, DYNJ82999, DYNJ82999A; xx. ANGIO/PICC PACK, Model Number: DYNJ36049A; yy. ANGIOGRAM, Model Number: DYNJ0149444N; zz. ANGIOGRAPHIC TRAY, Model Number: DYNJ67320A; aaa. ANGIOGRAPHY DRAPE PACK, Model Numbers: 00-400305R, DYNJ49621C, DYNJ63060B, DYNJ63684G, DYNJ68065B, DYNJ63684G; bbb. ANGIOGRAPHY PACK, Model Numbers: DYNJ44293F, DYNJ45059B, DYNJ55252C, DYNJ65190D, DYNJ65190F, DYNJ66476A, DYNJ67144A; ccc. ANGIOGRAPHY PACK-LF, Model Numbers: DYNJ0290716M, DYNJ0854485V; ddd. ANGIOPLASTY PACK, Model Number: DYNJ44700J; eee

MEDLINE INDUSTRIES, LP - Northfield

🏥 Medical Devices Class I - Dangerous

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

May 15, 2023 Infusion Pumps Nationwide View Details →

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. 18GX6" FEMORAL ART LINE KIT, Model Number: ART960; b. 20Gx3" RADIAL ART LINE KIT, Model Number: ART970; c. 20GX6" FEMORAL ART LINE KIT, Model Number: ART1165; d. 3" RADIAL ARTERIAL LINE KIT, Model Number: ART240A; e. 6" FEMORAL ARTERIAL LINE KIT, Model Number: ART245A, ART245B; f. A LINE TRAY, Model Number: ART690; g. A-LINE INSERTION TRAY, Model Number: ART645; h. AMNIOCENTESIS TRAY, Model Number: MNS8750; i. ART LINE SECUREMENT KIT W/LIDOCAINE, Model Number: DT22570A; j. ART LINE TRAY, Model Number: ART865; k. ARTERIAL LINE BUNDLE, Model Number: ART255, ART560; l. ARTERIAL LINE TRAY, Model Number: ART840; m. ARTHROGRAM TRAY, Model Number: SPEC0232; n. BASIC BIOPSY TRAY, Model Number: DYNDH1534; o. BEDSIDE PIGTAIL THORACOSTOMY PROCEDURE, Model Number: MNS12065; p. BEDSIDE PROCEDURE PREP KIT, Model Number: MNS7695A; q. BIOPSY TRAY, Model Number: DYNDH1661, MNS8705; r. BIOPSY/ASPIRATION TRAY, Model Number: BT235A; s. BRST BX Tray, Model Number: DYNDH1389A; t. CATHETER PREP KIT, Model Number: DYNDC2638, DYNDC2638A; u. CENTRAL LINE INSERTION KIT, Model Number: DT15975; v. CENTRAL LINE PROCEDURE KIT, Model Number: DT22260; w. CHEST TUBE INSERTION TRAY, Model Number: TRICHT1120; x. CONTINUOUS NERVE BLOCK PREP KIT, Model Number: MNS6660; y. CVC ACCESSORY BUNDLE, Model Number: CVI4505; z. CVC INFANT INSERTION PACK, Model Number: CVI4770; aa. CVC INSERTION BUNDLE, Model Number: CVI3940; bb. CVC INSERTION BUNDLE- ADD A CATHETER, Model Number: CVI4905; cc. CVL INSERTION TRAY, Model Number: DYNDC1786A; dd. DIAGNOSTIC PROCEDURE TRAY, Model Number: DYNJRA0585; ee. DIALYSIS CATHETER INSERTION KIT, Model Number: CVI4050; ff. DIALYSIS/CVC BUNDLE W/O CATHETER, Model Number: CVI4655; gg. EXTREMITY PACK, Model Number: CVI4680; hh. FEMORAL ARTERIAL LINE BUNDLE, Model Number: ART1005; ii. FEMORAL ARTERIAL LINE TRAY, Model Number: ART945; jj. FISHLINE KIT, Model Number: CVI4725; kk. FNA TRAY, Model Number: DYNDH1123B; ll. GENERAL ASPIRATION TRAY - CHOICE, Model Number: DYNDH1397; mm. HEMODIALYSIS ACCESS KIT, Model Number: DT12970; nn. IMPLANT ACCESSORY PACK, Model Number: MNS12955; oo. MAX BARRIER ART LINE KIT, Model Number: ART950; pp. MAX BARRIER KIT, Model Number: DYND2673B; qq. MIDLINE INSERTION, Model Number: DYNDC2890; rr. MINOR PROCEDURE TRAY, Model Number: DYNDA2418; ss. MULTI-PURPOSE SPECIALS TRAY, Model Number: MNS8565; tt. MVHS CVC LUMEN TRAY, Model Number: CVI4920; uu. NECK BIOPSY KIT, Model Number: DYNDH1449A; vv. NERVE BLOCK TRAY, Model Number: MNS8315; ww. PARA/THORACENTESIS TRAY, Model Number: DYNDH1292, DYNDH1470, DYNDH1470A, DYNDH1470B; xx. PEDI ULTRASOUND GUIDED PIV KIT, Model Number: IVS3320; yy. PEDIATRIC PICC INSERTION TRAY, Model Number: CVI4450A; zz. PEDIATRIC ULTRASOUND KIT, Model Number: MNS12995A; aaa. PERCUTANEOUS CHEST TUBE KIT, Model Number: CHT1825; bbb. PERM CATH KIT, Model Number: MNS10755; ccc. PICC INSERTION BUNDLE, Model Number: CVI3830, CVI4025, CVI4025A; ddd. PICC INSERTION BUNDLE (P/S), Model Number: CVI4025; eee. PICC INSERTION KIT, Model Number: CVI3735, CVI4615; fff. PICC SUPPLEMENTAL KIT, Model Number: DYNDC2373A; ggg. PIV WITH ULTRASOUND KIT, Model Number: DYNDC2399A; hhh. PORT INSERTION KIT, Model Number: MNS11590; iii. PPE BUNDLE KIT, Model Number: DT13351A; jjj. RADIOLOGY TRAY, Model Number: MNS11625; kkk. SCLEROTHERAPY KIT, Model Number: DYNDA2148A; lll. THYROID BIOPSY TRAY-CHOICE, Model Number: DYNDA2446; mmm. THYROID FNA TRAY, Model Number: DYNDA2238, DNDA2238A. nnn. TOTE MCADAMS OSC SHLDR ARTHRO, Model Number: DYKM1790A; ooo. TREATMENT PACK, Model Number: TPO71922-3; ppp. U/S CORE BIOPSY KIT, Model Number: DYNDH1121C; qqq

MEDLINE INDUSTRIES, LP - Northfield

🏥 Medical Devices Class I - Dangerous

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

May 15, 2023 Implants & Prosthetics Nationwide View Details →

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIOGRAM TRAY, Model Number: DYNJ33638J; b. BLOCK TRAY, Model Number: DYNJRA1543; c. BMT- NERVE PERIPH PK, Model Number: DYNJRA1247; d. CVOR ANGIOGRAPHY PACK-LF, Model Number: DYNJ42367B; e. FEMORAL BLOCK TRAY, Model Number: DYNJRA1739; f. NERVE BLOCK ACCESSORY PACK, Model Number: DYNJ0134147D; g. NERVE BLOCK PREP TRAY, Model Numbers: DYNJRA1220, DYNJRA1571; h. NERVE BLOCK SUPPORT TRAY, Model Number: DYNJRA1109A; i. NERVE BLOCK TRAY, Model Numbers: DYNJRA0656A, DYNJRA1287A, DYNJRA1604; j. NERVE BLOCK TRAY/PREFERRED, Model Number: DYNJRA0725; k. PK, RADIOLOGY-NEURO-IR, Model Number: DYNJ51107B; l. SINGLE SHOT NERVE BLOCK TRAY, Model Number: DYNJRA1773; m. ULTRASOUND BLOCK PREP TRAY, Model Number: PAIN1622A; n. UNIVERSAL BLOCK TRAY/2, Model Number: DYNJRA1635A;

MEDLINE INDUSTRIES, LP - Northfield

🏥 Medical Devices Class I - Dangerous

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

May 15, 2023 Infusion Pumps Nationwide View Details →

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ELECTROPHYSIOLOGY PACK-LF, Model Number: DYNJ0842825D; b. EMANUEL EP TRAY, Model Number: DYNJ49933I, DYNJ49933J; c. ENDO LASER ABLATION PK-LF, Model Number: DYNJ44808G; d. ENDO VASCULAR, Model Number: DYNJ51304B, DYNJ51304C; e. ENDO VASCULAR PACK, Model Numbers: DYNJ0678934D, DYNJ0678934F, DYNJ82567; f. ENDO VASCULAR PACK-LF, Model Number: DYNJ0676055N; g. ENDOVASCULAR, Model Numbers: DYNJ63343A, DYNJ63343B, DYNJ63343D, DYNJ63343F, DYNJ908880; h. ENDOVASCULAR CDS, Model Number: CDS983394I, CDS983394J, CDS983394K; i. ENDOVASCULAR IMF 88370-LF, Model Number: DYNJVB91067; j. ENDOVASCULAR KIT, Model Number: DYNJ906354D, DYNJ906354F; k. ENDOVASCULAR PACK, Model Number: DYNJ0678934I, DYNJ44934F, DYNJ905726C, DYNJ905726D; l. ENDOVASCULAR PACK-LF, Model Number: DYNJ42831F; m. ENDOVASCULAR -TEMPLE, Model Number: DYNJ67750, DYNJ67750A, DYNJ67750B, DYNJ67750C; n. ENDOVENOUS ABLATION PACK, Model Number: DYNJ80489; o. ENDOVENOUS BASIC PACK, Model Number: DYNJ48456C, DYNJ69108A; p. ENDOVENOUS PACK, Model Number: DYNJ83606; q. ENT FREE FLAP, Model Number: SYNJ910018B; r. EP ANGIO PACK, Model Number: DYNJ25749S; s. EP DRAPE PACK-LF, Model Number: DYNJ47645C; t. EP LAB, Model Number: DYNJ59392D, DYNJ59392F; u. EP PACER PACK, Model Number: DYNJ67770; v. EP PACK, Model Number: DYNJ23456K, DYNJ68019, DYNJ81716, DYNJ81716A, DYNJ81716B; w. EP PROCEDURE PACK, Model Number: DYNJ67771; x. EP TRAY, Model Number: DYNJ31928D; y. FEM POP BYPASS PACK-LF, Model Number: DYNJ53480F; z. FEM POP PACK, Model Number: DYNJ67487C; aa. FISTULA PACK, Model Number: DYNJ82711; bb. FISTULA SAVANNAH PACK, Model Number: DYNJ69943A; cc. GENERAL HEART, Model Number: DYNJ907915; dd. GROTH LASER VEIN CDS, Model Number: CDS984193O; ee. GV PERIPHERAL VASCULAR PACK, Model Number: DYNJ46590I, DYNJ46590J, DYNJ46590K; ff. GWINNETT ENDOVASCULAR WSTE MGT, Model Number: DYNJ68198; gg. HCP OPEN HEART ACCESSORY PACK, Model Number: DYNJ51925F; hh. HEART A PACK, Model Number: DYNJ0541930N; ii. HEART FAILURE PACK, Model Number: DYNJ64877B; jj. HEART FAILURE PK, Model Number: DYNJ55528A, DYNJ55528B, DYNJ55528C; kk. HEART PACK, Model Number: DYNJ48424A; ll. HEART VALVE PACK, Model Number: DYNJ58365C, DYNJ58365F, DYNJ58365G, DYNJ58365J; mm. HEART VEIN NYC-ARTERIAL PACK, Model Number: DYNJ62851B; nn. HEART VEIN NYC LASER ABLATION, Model Number: DYNJ62850A; oo. HMT TAVR, Model Number: DYNJ905495D, DYNJ905495F; pp. HMT VEIN PACK, Model Number: DYNJ38756B; qq. HP MINOR VASCULAR, Model Number: DYNJ907571A, DYNJ907571B; rr. INTERVENTIONAL RAD L J-LF, Model Number: DYNJ40215C; ss. INTERVENTIONAL RADIOLOGY, Model Number: DYNJ52756A; tt. INTERVENTIONAL RADIOLOGY PACK, Model Number: DYNJ47138B; uu. IR ANGIOGRAM LIGHT PK, Model Number: DYNJ82858A; vv. IR ANGIOGRAM PACK, Model Number: DYNJ82859A; ww. JVL-PACK VNUS CLOSURE, Model Number: DYNJ66076; xx. KIT CARDIAC ROBOTIC MID CAB, Model Number: DYKMBNDL22C; yy. KIT LB OPEN HEART, Model Number: CDS840487G; zz. KIT MAJOR VASCULAR, Model Number: DYNJ907262, DYNJ907262B; aaa. KIT NEURO CAROTID SETUP, Model Number: DYKMBNDL148A; bbb. KIT OPEN HEART, Model Number: DYNJ906113; ccc. KIT OR AORTOGRM ANGIOPLAST PHT, Model Number: DYNJ906086B; ddd. KIT VASCULAR AAA REPAIR, Model Number: DYKMBNDL23; eee. KIT VASCULAR ACCESS PHT, Model Number: DYNJ906098, DYNJ906098A; fff. KIT VASCULAR CAROTID, Model Number: DYKMBNDL118A; ggg. KIT VASCULAR RF, Model Number: DYNJ906960A; hhh. KT TAVR PACK, Model Number: DYNJ56283C, DYNJ56283D, DYNJ56283F; iii. LASER ABLATION, Model Number: DYNJ48962B; jjj. LASER AND VEIN PACK, Model Number: DYNJ38995C, DYNJ67725; kkk. LASER PACK, Model Number: DYNJ65294; lll. LB OPEN HEART BOX, Model Number: DYNJ905859B; mmm. LEE VEIN PACK, Model Number: DYNJ54906B; nnn. LEG VASCULAR SUPPLY -LF, Model Number: D

MEDLINE INDUSTRIES, LP - Northfield

🏥 Medical Devices Class I - Dangerous

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

May 15, 2023 Other Medical Devices Nationwide View Details →

Always-On Tip Tracked Instruments (SPiN Drive instruments) SPiN Xtend 2.0mm OD, 21ga Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic brINS-0362onchoscopy are currently used for visualizing Model: INS-5450

Olympus Corporation of the Americas

🏥 Medical Devices Class I - Dangerous

Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could result in a potential procedural delay

May 15, 2023 Surgical Instruments Nationwide View Details →

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CVC INFANT INSERTION PACK, Model Number: CVI4770A; b. INSERTION BUNDLE, Model Number: DT21275; c. MIDLINE DRESSING CHANGE KIT, Model Number: EBSI1464; d. MIDLINE INSERTION KIT, Model Number: DT20155; e. PICC LINE DRESSING TRAY, Model Number: DT22045; f. UNIVERSAL DRESSING PPE KIT, Model Number: DT22065; g. UNIVERSAL DRESSING & PPE KIT, Model Number: DT22065; h. VA MAINTENANCE PACK, Model Number: EBSI1382;

MEDLINE INDUSTRIES, LP - Northfield

🏥 Medical Devices Class I - Dangerous

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

May 15, 2023 Infusion Pumps Nationwide View Details →

Always-On Tip Tracked Instruments (SPiN Drive instruments) 19ga ANSO Histology Needle, 12mm L, 1.8mm OD-Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic brINS-0362onchoscopy are currently used for visualizing Model: INS-0382

Olympus Corporation of the Americas

🏥 Medical Devices Class I - Dangerous

Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could result in a potential procedural delay

May 15, 2023 Surgical Instruments Nationwide View Details →

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ABLATION/DRAINAGE PACK, Model Number: DYNJ53658B; b. BASIC BIOPSY TRAY, Model Number: DYNDH1534; c. BIOPSY PACK, Model Number: DYNDH1124, DYNJ50485; d. BIOPSY PACK-LF, Model Number: DYNJ0747885G; e. BIOPSY RAD CT, Model Number: DYNJ59752A; f. BIOPSY TRAY, Model Number: DYNDH1748, DYNJ34637F, DYNJ34637G, DYNJ43076, DYNJ43076A, DYNJ62690; g. BIOPSY WITH PROB COVER WRO-LF, Model Number: DYNJ42307A; h. BREAST BIOPSY KIT, Model Number: DYNDA1224B; i. BREAST BIOPSY TRAY, Model Number: DYNDH1266, DYNDH1302, DYNDH1345A, DYNDH1677; j. CABARRUS BIOPSY TRAY, Model Number: DYNDH1670; k. CORE BIOPSY PACK-LF, Model Number: DYNJ42752A; l. GENERAL BIOPSY PACK, Model Number: P365500; m. IGT BIOPSY PACK-LF, Model Number: DYNJ38616A; n. IR BIOPSY PACK, Model Number: DYNJ63688I; o. PROSTATE BIOPSY, Model Number: DYNJVB91015A; p. PROSTATE BIOPSY PACK, Model Number: DYNJ56578; q. RENAL BIOPSY TRAY, Model Number: SPEC0168; r. REVAMP BIOPSY TRAY, Model Number: DYNDH1147A; s. SOFT TISSUE BIOPSY, Model Number: DYNDH1750; t. THYROID BIOPSY TRAY, Model Number: DYNDH1288; u. U/S CORE BIOPSY KIT, Model Number: DYNDH1121C; v. UL BIOPSY TRAY, Model Number: DYNDH1778; w. ULTRASOUND BIOPSY, Model Number: DYNDH1542B; x. ULTRASOUND BREAST BIOPSY, Model Number: DYNDH1496A; y. ULTRASOUND CORE BIOPSY TRAY, Model Number: DYNDH1786; z. US BREAST BIOPSY PACK, Model Number: DYNJ61992B;

MEDLINE INDUSTRIES, LP - Northfield

🏥 Medical Devices Class I - Dangerous

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

May 15, 2023 Other Medical Devices Nationwide View Details →

OEC 9900 Systems with 9-inch Image Intensifier

GE OEC Medical Systems

🏥 Medical Devices Class I - Dangerous

Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved, which may result in the image intensifier falling, which could lead to injuries such as fractures, hematoma, contusion, bruise, pain.

May 15, 2023 Other Medical Devices Nationwide View Details →

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CATH LAB BASIN PACK, Model Number: DYNJ69864A; b. DELNOR VASCULAR BASIN PACK, Model Number: DYNJ82257; c. FLAP PACK, Model Number: DYNJ60224C;

MEDLINE INDUSTRIES, LP - Northfield

🏥 Medical Devices Class I - Dangerous

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

May 15, 2023 Other Medical Devices Nationwide View Details →

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CENTRAL CATHETER INSERTION TRAY, Model Number: CVI680C; b. CVC INSERTION ACCESSORY KIT, Model Number: ECVC7880; c. CVL INSERTION TRAY, Model Number: DYNDC1786A; d. ULTASOUND GUIDED PIV INSERTION, Model Number: IVS3635B; e. USG PIV INSERTION KIT, Model Number: DYNDV2480A;

MEDLINE INDUSTRIES, LP - Northfield

🏥 Medical Devices Class I - Dangerous

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

May 15, 2023 Surgical Instruments Nationwide View Details →

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CENTRAL LINE INSERT KIT W/O CA, Model Number: CVI3755; b. CENTRAL LINE KIT, Model Number: DYNDC2582, DYNDC2582A; c. CENTRAL LINE PACK-COMPANION, Model Number: DYNJ47215D; d. CENTRAL LINE TRAY, Model Number: DYNJ42902B; e. CENTRAL LINE UNIVERSAL INSERTION, Model Number: CVI3780; f. CLOSURE PACK, Model Number: DYNJ83054A; g. DBD-PICC LINEPACK PCLUI642-LF, Model Number: DYNJ47717A; h. ER CENTRAL LINE KIT, Model Number: P155508B, P155508C; i. HEMODIALYSIS CENTRAL LINE, Model Number: DYNJ63347; j. LINE KIT, Model Number: DYNJ47987A; k. PEDIATRIC CENTRAL LINE KIT, Model Number: DYNJ38885B; l. PK CUST CENTRAL LINE PACK, Model Number: DYNJ60586; m. TRAY LACERATION, Model Number: DYNDL1134A; n. TUNNEL LINE PACK, Model Number: DYNJ67990; o. ULTRASOUND GUIDED IV/MIDLINE K, Model Number: DYNDV2385;

MEDLINE INDUSTRIES, LP - Northfield

🏥 Medical Devices Class I - Dangerous

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

May 15, 2023 Infusion Pumps Nationwide View Details →

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. MULTI-LUMEN CVC BUNDLE KIT, Model Number: ECVC475; b. MULTI-LUMEN CVC INSERTION BUNDLE, Model Number: ECVC3900; c. MULTIMED 16G 1L 20CM CVC STOCK+BUNDLE US, Model Number: STCVC20US; d. MULTIMED 7F 2L 16CM STOCK + BUNDLE US, Model Number: STCVC21US; e. MULTIMED 7F 3L 16CM CVC BUNDLE, Model Number: ECVC6585A; f. MULTIMED 7F 3L 20CM PI, Model Number: ECVC7235A; g. MULTIMED 7FR 16CM CVC STK + BUNDLE-US, Model Number: STCVC03US; h. MULTIMED 7FR 3L 16CM CVC BUNDLE, Model Number: ECVC6655A; i. MULTIMED 7FR 3L 20CM CVC BUNDLE-US, Model Number: ECVC7935; j. MULTIMED 7FR 3L 20CM CVC STK + BUNDLE-US, Model Number: STCVC04US; k. MULTIMED 7FR, 20CM, 3L CVC BUNDLE, Model Number: ECVC7670; l. MULTIMED 8.5F 20CM QUAD CVC BUNDLE, Model Number: ECVC7090; m. MULTIMED 8.5FR 16CM QUAD CVC BUNDLE, Model Number: ECVC6930; n. MULTIMED 8.5FR 2L 16CM CVC STK+BUNDLE-US, Model Number: STCVC13US; o. NEURO CATH PACK (NCLUA)227-LF, Model Number: DYNJ47646D, DYNJ47646F, DYNJ47646G, DYNJ47646I; p. O.R. DOUBLE LUMEN INSERTION TRAY, Model Number: ECVC8010; q. OLEAN GENERAL CVC BUNDLE, Model Number: ECVC4615; r. OR ANGIO PACK, Model Number: DYNJ59184B; s. OR ANGIOGRAM, Model Number: DYNJ909267; t. OR ANGIOGRAPHY DRAPE, Model Number: DYNJ906297D; u. OR ANGIOGRAPHY PACK, Model Numbers: DYNJ67245A, DYNJ67245B; v. OR PERCUTANEOUS CATH PACK, Model Number: DYNJ63372A, DYNJ63372B, DYNJ63372C, DYNJ63372D; w. OR VANTEX 7FR 3L 16CM CVC, Model Number: ECVC6665; x. OR VASCULAR ANGIO PACK, Model Number: DYNJ69763, DYNJ69763A; y. PACK CARDIAC CATH, Model Number: DYNJ65481; z. PACK PERCUTANEOUS ANGIO CHRG, Model Number: DYNJ60112B; aa. PEDIATRIC CATH ANGIO PACK, Model Number: DYNJ54755G, DYNJ54755I; bb. PEDIATRIC CATH PACK-LF, Model Number: DYNJ0843244K; cc. PERCUTANEOUS ANGIO PACK-LF, Model Number: DYNJ57645C; dd. PERCUTANEOUS PACK, Model Number: DYNJ46035C, DYNJ46035D; ee. PERMA CATH PACK, Model Number: DYNJ62007A; ff. PI CVC BUNDLE, VANTEX 3L, 16CM, Model Number: ECVC3665; gg. PI CVC BUNDLE, VANTEX 3L, 20CM, Model Number: ECVC6190; hh. PI VANTEX 7FR 16CM 3L CVC BUNDLE-MAXPLUS, Model Number: ECVC4380; ii. PI VANTEX 7FR 16CM 3L CVC-MicroClave, Model Number: ECVC5655; jj. PI VANTEX 7FR 20CM 3L CVC-MicroClave, Model Number: ECVC5650; kk. PI VANTEX 8.5FR 16CM 4L CVC-MicroClave, Model Number: ECVC5660; ll. PI VANTEX 8.5FR 20CM 4L CVC-MicroClave, Model Number: ECVC5685; mm. PICC LINE PACK-LF, Model Number: DYNJ0275614F; nn. PK, RADIOLOGY, Model Number: DYNJ43894B; oo. PORT A CATH PACK, Model Number: DYNJ59307F; pp. PORT PACK, Model Number: DYNJ58162; qq. PORTACATH PACK, Model Number: DYNJ51240A; rr. QUAD LUMEN CVC BUNDLE 8.5F, 16CM, Model Number: ECVC3700; ss. QUAD LUMEN CVC BUNDLE, 8.5F, 20CM, Model Number: ECVC4995; tt. QUAD LUMEN CVC INSERTION BUNDLE, Model Numbers: ECVC5025, ECVC4135; uu. QUAD LUMEN KIT, Model Number: ECVC5820; vv. RADIOFREQUENCY ABLATION PACK, Model Number: DYNJ65913; ww. RADIOLOGY PACK, Model Numbers: DYNJ41190, DYNJ43894A, DYNJ44087A, DYNJ44524F, DYNJ52806C; xx. RADIOLOGY PACK 108402-LF, Model Number: DYNJVB1000; yy. RR-ADULT ECMO PACK, Model Number: DYNJ69742, DYNJ69742B; zz. SHEATH INTRODUCER BUNDLE, Model Number: ECVC2930, ECVC5835; aaa. SK-ANGIO TRAY-LF, Model Number: DYNJ82030; bbb. SK-INTERVENTIONAL TRAY-LF, Model Number: DYNJ82041; ccc. SPECIAL PROCEDURE CATH LAB PK, Model Number: DYNJ68729; ddd. SPECIAL PROCEDURE PACK, Model Number: DYNJ38314G; eee. SPECIAL PROCEDURE PACK-LF, Model Number: DYNJ0416535AA, DYNJ0416535W, DYNJ0458661C; fff. SPECIAL PROCEDURE PK-LF, Model Number: DYNJ0604508R; ggg. SPECIAL PROCEDURES, Model Number: DYNJ23288C; hhh. STANDARD ANGIO TRAY MV, Model Number: DYNJ67136A; iii. STD, AVA ,3XI ,3L 8.5F KIC, Model Number: ECVC7465A; jjj. STD, AVA, 3L, 9F, HF, KIC, Model Number: ECVC810

MEDLINE INDUSTRIES, LP - Northfield

🏥 Medical Devices Class I - Dangerous

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

May 15, 2023 Other Medical Devices Nationwide View Details →