All Recalls

92,900 total recalls in our database

MEDLINE convenience kits labeled as: 1) ZALE HEAD & NECK CDS, REF CDS983184I; 2) ENT MINOR, REF CDS983466L; 3) EAR, REF CDS983486K; 4) HEAD AND NECK, REF CDS984259N; 5) HEAD AND NECK, REF CDS984259O; 6) HEAD & NECK CDS, REF CDS984282L; 7) T & A, REF CDS984895I; 8) T & A, REF CDS984895J; 9) T&A, REF CDS984895K; 10) HEAD NECK PACK-LF, REF DYNJ0101206D; 11) HEAD NECK PACK-LF, REF DYNJ0101206F; 12) MAJOR EAR PACK-LF, REF DYNJ0101314D; 13) NILES T A PACK, REF DYNJ0101397M; 14) NILES T A PACK RFID, REF DYNJ0101397N; 15) THYROID PACK-LF, REF DYNJ0131777I; 16) THYROID PACK-LF, REF DYNJ0131777J; 17) THYROID PACK-LF, REF DYNJ0131777K; 18) THYROID PACK-LF, REF DYNJ0131777L; 19) MINOR ENT HARPER PACK-LF, REF DYNJ0160700F; 20) MAJOR ENT HARPER PACK-LF, REF DYNJ0161710G; 21) MAJOR ENT HARPER PACK-LF, REF DYNJ0161710I; 22) T&A PACK, REF DYNJ02462L; 23) ENT/HEAD & NECK PACK, REF DYNJ02463J; 24) ENT BASIC PACK-LF, REF DYNJ0387711F; 25) MAJOR ENT MZ PACK-LF, REF DYNJ0429404O; 26) MAJOR ENT PACK-LF, REF DYNJ0451506P; 27) EAR PACK-LF, REF DYNJ0774664K; 28) MAJOR HEAD/NECK PACK-LF, REF DYNJ0826705N; 29) TRANSPHENOIDAL PACK-LF, REF DYNJ0843898I; 30) MINOR HEAD & NECK #40-RF, REF DYNJ21948S; 31) NASALPLASTY #61-RF, REF DYNJ27320V; 32) DB ENT CSTM PACK-LF, REF DYNJ33585F; 33) ENT RECONSTRUCTION PK, REF DYNJ37531G; 34) BEC MOHS PACK, REF DYNJ43111G; 35) SVMMC HEAD AND NECK PACK, REF DYNJ43776G; 36) TONSIL PACK, REF DYNJ44170G; 37) T AND A PACK, REF DYNJ44982J; 38) MAJOR ENT PACK, REF DYNJ45576B; 39) MAJOR ENT PACK, REF DYNJ48370C; 40) HEAD & NECK PACK, REF DYNJ52419J; 41) HEAD & NECK PK-RFID, REF DYNJ52419K; 42) BL THYROID PK RFID- LF, REF DYNJ52426J; 43) HEAD & NECK PACK, REF DYNJ52758G; 44) THYROID PACK, REF DYNJ53648B; 45) SMH HEAD & NECK PACK, REF DYNJ56995C; 46) CHRISTUS SR HEAD AND NECK PACK, REF DYNJ60922F; 47) HEAD&NECK PACK, REF DYNJ61309B; 48) MHPB HEAD AND NECK PACK, REF DYNJ62032B; 49) SMH THYROID PACK, REF DYNJ62649A; 50) TRANSSPHENOIDAL, REF DYNJ63315B; 51) TYMPANOPLASTY, REF DYNJ63332F; 52) AFCH TONSIL, REF DYNJ63333B; 53) AFCH TONSIL, REF DYNJ63333C; 54) TAC THYROIDECTOMY PACK, REF DYNJ63334C; 55) TAC THYROIDECTOMY PACK, REF DYNJ63334D; 56) HEAD NECK PACK IP, REF DYNJ63336B; 57) HEAD NECK PACK IP, REF DYNJ63336C; 58) THYROID TRAY FFX, REF DYNJ63625C; 59) ENT DRAPE PACK, REF DYNJ63890A; 60) HEAD AND NECK, REF DYNJ64235B; 61) PACK,HEAD AND NECK, REF DYNJ65487B; 62) PEDI ENT PACK, REF DYNJ67401B; 63) ACH HEAD & NECK PACK-LF, REF DYNJ67754B; 64) OSC HEAD AND NECK PACK, REF DYNJ67985B; 65) OSC HEAD AND NECK PACK, REF DYNJ67985C; 66) ENT HEAD NECK PACK, REF DYNJ68211B; 67) ENT BASIC PACK-LF, REF DYNJ69587B; 68) EAR PACK, REF DYNJ82172; 69) ENT MINOR PACK, REF DYNJ82175; 70) ENT MINOR PACK, REF DYNJ82175B; 71) FACIAL PACK, REF DYNJ82177; 72) FACIAL PACK, REF DYNJ82177B; 73) MEDIASTINOSCOPY PACK, REF DYNJ82194; 74) EAR ENT PACK, REF DYNJ82285; 75) HEAD AND NECK PACK, REF DYNJ82654A; 76) HEAD AND NECK PACK, REF DYNJ82654B; 77) GENERAL EAR PACK, REF DYNJ82656C; 78) T AND A PACK, REF DYNJ82657A; 79) T AND A PACK, REF DYNJ82657B; 80) ORAL NASAL, REF DYNJ901073G; 81) ORAL NASAL, REF DYNJ901073I; 82) EAR-LF, REF DYNJ901801K; 83) T&A, REF DYNJ902116I; 84) ENT RESECTION, REF DYNJ902126I; 85) OMFS, REF DYNJ902258J; 86) THYROID, REF DYNJ902508I; 87) HEAD AND NECK, REF DYNJ903810C; 88) TRIPOINT HEAD AND NECK, REF DYNJ904491J; 89) TRIPOINT HEAD AND NECK, REF DYNJ904491K; 90) PLASTIC CRANIOPLASTY-LF, REF DYNJ904558F; 91) CW T&A SINUS, REF DYNJ906052B; 92) HEAD&NECK, REF DYNJ906655F; 93) HEAD&NECK, REF DYNJ906655G; 94) PACK,COCHLEAR IMPLANT, REF DYNJ906901A; 95) HEAD&NECK, REF DYNJ906948B; 96) HEAD&NECK, REF DYNJ906948C; 97) WMC COCHLEAR IMPLANT ADD ON, REF DYNJ907206F; 98) PLASTIC ENT, REF DYNJ907393C; 99) PLASTIC ENT, REF DYNJ907393D; 100) PLASTIC ENT - NTSC, REF DYNJ907411A; 101) ENT-LF, REF DYNJ907577; 102) MINOR ENT # 56653-LF, REF DYNJVB91072

MEDLINE INDUSTRIES, LP - Northfield

πŸ₯ Medical Devices Class I - Dangerous

Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.

Oct 9, 2024 Implants & Prosthetics Nationwide View Details β†’

GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if applicable) scan modes, after the first image of an exam, each subsequent image can be rotated by an increasing amount. The amount of progressive image rotation is dependent on the gantry speed and the duration of the scan. The final image in the exam can be rotated up to a maximum of ~56 degrees. The entire anatomy rotates as a whole by equal degrees, without distortion, and the anatomical positioning and z-axis of the images remains correct. Small degrees of image rotation might not be noticed. If image rotation is noticed and necessitates a rescan of the patient, the same image rotation will reoccur.

Nov 5, 2024 Other Medical Devices View Details β†’
πŸ₯ Medical Devices Class I - Dangerous

Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601-2-54 and or 21 CFR 1020.32(c) with respect to wired hand switch may fail when being exposed to mechanical stress such as shocks (e.g. dropping) or impacts can irreversibly damage the switching element in the hand switch. A defective switching element may then potentially initiate unintended radiation of the connected mobile X-ray unit.

Aug 8, 2024 Other Medical Devices View Details β†’

Potential for falsely depressed auto-diluted results for samples above the measuring interval of 18.00 mg/L, up to 30.00 mg/L, when using the Atellica CH ΒΏ2-Microglobulin (B2M) reagent.

Oct 21, 2024 Diagnostic Equipment Nationwide View Details β†’

Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.

Oct 9, 2024 Other Medical Devices Nationwide View Details β†’
πŸ₯ Medical Devices Class I - Dangerous

BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.

Oct 31, 2024 Other Medical Devices Nationwide View Details β†’
πŸ₯ Medical Devices Class I - Dangerous

BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.

Oct 31, 2024 Surgical Instruments Nationwide View Details β†’

MEDLINE convenience kits labeled as: 1) MAMMOPLASTY-LF, REF CDS983478L; 2) MAMMOPLASTY-LF, REF CDS983478M; 3) PLASTICS FREE FLAP, REF CDS983493M; 4) PLASTIC TORSO-LF, REF CDS983496L; 5) PLASTIC TORSO-LF, REF CDS983496M; 6) PLASTIC HEAD AND NECK-LF, REF CDS983498N; 7) ACH PLASTICS BREAST-LF, REF CDS983639J; 8) ACH PLASTICS BREAST-LF, REF CDS983639K; 9) BREAST ABD, REF CDS984267J; 10) DAY SURG PLASTIC CDS, REF CDS984993N; 11) DAY SURG PLASTIC CDS, REF CDS984993O; 12) DAY SURG PLASTIC CDS, REF CDS984993P; 13) PLASTIC PACK, REF DYNJ00264L; 14) LKLND BRST CHST PK RFID-LF, REF DYNJ0101536L; 15) OCULOPLASTY PACK-LF, REF DYNJ0252232U; 16) PLASTICS PACK, REF DYNJ02615G; 17) BREAST PBM-LF, REF DYNJ0318423M; 18) FLAP RECONSTRUCTION PACK-LF, REF DYNJ0378388P; 19) BREAST PACK-LF, REF DYNJ0378394R; 20) BREAST PACK-LF, REF DYNJ0378394S; 21) BREAST PACK-LF, REF DYNJ0378394T; 22) BREAST ABDOMINOPLASTY MZ PK-LF, REF DYNJ0428947K; 23) BREAST ABDOMINOPLASTY MZ PK-LF, REF DYNJ0428947L; 24) ASC MAJOR PLASTIC PACK-LF, REF DYNJ0854517M; 25) ASC ENT PLASTIC PACK-LF, REF DYNJ0854650J; 26) BREAST PACK-LF, REF DYNJ0956628M; 27) BREAST PACK-LF, REF DYNJ0956628N; 28) BREAST PACK-LF, REF DYNJ0956628O; 29) AUGMENTATION #87-RF, REF DYNJ27319U; 30) AUGMENTATION #87-RF, REF DYNJ27319V; 31) PLASTICS PACK-LF, REF DYNJ36107J; 32) PLASTIC MINOR PACK, REF DYNJ37620F; 33) CHEST/BREAST PACK, REF DYNJ39118C; 34) PLASTIC BREAST PACK, REF DYNJ40620C; 35) PLASTIC BREAST PACK, REF DYNJ40620D; 36) BREAST RECONSTRUCTION-HOULE, REF DYNJ44852M; 37) BREAST MINOR PK RFID, REF DYNJ52409J; 38) BREAST MAJOR PACK, REF DYNJ52435J; 39) BREAST MAJOR PK RFID, REF DYNJ52435K; 40) BREAST PACK, REF DYNJ57527C; 41) TRANSGENDER MASTECTOMY 2, REF DYNJ58257G; 42) BREAST PACK SSC, REF DYNJ59733A; 43) BREAST PACK, REF DYNJ60511B; 44) BREAST PACK, REF DYNJ60511F; 45) PLASTIC PACK, REF DYNJ61755B; 46) TYMPANOPLASTY, REF DYNJ63332D; 47) BREAST PACK, REF DYNJ63369D; 48) BREAST SURGERY FOAKS, REF DYNJ63577C; 49) MAJOR PLASTIC FOAKS, REF DYNJ63579C; 50) MAJOR PLASTIC PACK FAIRFAX, REF DYNJ63612C; 51) MAJOR BREAST WOMENS PACK, REF DYNJ63647C; 52) PLASTIC BASIN PACK, REF DYNJ63883B; 53) PLASTICS WOODBURN, REF DYNJ64001B; 54) BREAST PK, REF DYNJ64144B; 55) BREAST PK, REF DYNJ64144C; 56) PACK,PLASTIC, REF DYNJ65477B; 57) PACK,PLASTIC BASIC ASC, REF DYNJ65485A; 58) OSC BREAST PACK, REF DYNJ65808A; 59) CHEST/BREAST PACK, REF DYNJ66495A; 60) PLASTICS PACK, REF DYNJ66610B; 61) BREAST PACK, REF DYNJ66739B; 62) MAJOR PLASTICS PACK, REF DYNJ67968A; 63) BREAST PACK, REF DYNJ68464A; 64) FLAP PACK, REF DYNJ80179A; 65) PLASTICS PACK, REF DYNJ81797A; 66) PLASTICS PACK, REF DYNJ81811A; 67) MINOR PLASTICS PACK, REF DYNJ82196; 68) MINOR PLASTICS PACK, REF DYNJ82196A; 69) DELNOR MAJOR PLASTICS PACK, REF DYNJ82248; 70) DELNOR SIMPLE PLASTIC PACK, REF DYNJ82250; 71) DELNOR SIMPLE PLASTIC PACK, REF DYNJ82250A; 72) DELNOR AUGMENTATION PACK, REF DYNJ82265; 73) DELNOR AUGMENTATION PACK, REF DYNJ82265A; 74) AUGMENTATION PACK, REF DYNJ82279; 75) AUGMENTATION PACK, REF DYNJ82279A; 76) PLASTIC SURGERY PACK, REF DYNJ82352; 77) PLASTIC SURGERY PACK, REF DYNJ82352A; 78) FREE FLAP 2 PACK, REF DYNJ82659B; 79) FREE FLAP 1 PACK, REF DYNJ82660A; 80) FREE FLAP 1 PACK, REF DYNJ82660B; 81) FACE PACK, REF DYNJ83532; 82) BREAST RECONSTRUCTION PACK-LF, REF DYNJ83612A; 83) PLASTIC PACK, REF DYNJ83856; 84) BREAST PACK, REF DYNJ84332; 85) MAJOR PLASTIC PACK, REF DYNJ84827; 86) PLASTICS PACK, REF DYNJ84966; 87) PLASTIC PACK, REF DYNJ85702; 88) FACIAL PLASTICS FLAP PACK, REF DYNJ86031; 89) BREAST-CHEST, REF DYNJ900294K; 90) GENERAL PLASTIC-LF, REF DYNJ901738O; 91) TRAM RECONSTRUCTION-LF, REF DYNJ901753L; 92) PLASTIC UNIVERSAL, REF DYNJ901792J; 93) MID HUDSON BREAST, REF DYNJ903614C; 94) MID HUDSON BREAST, REF DYNJ903614D; 95) MID HUDSON BREAST, REF DYNJ903614F; 96) MID HUDSON PLASTICS, REF DYNJ903616F; 97) MID HUDSON PLASTICS, REF DYNJ903616G; 98) MID

MEDLINE INDUSTRIES, LP - Northfield

πŸ₯ Medical Devices Class I - Dangerous

Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.

Oct 9, 2024 Infusion Pumps Nationwide View Details β†’
πŸ₯ Medical Devices Class I - Dangerous

High-level disinfection ("HLD") with Acecide-C disinfectant in the Olympus OER-Pro Automated Endoscope Reprocessor ("AER") has been removed as a compatible reprocessing method from the Instructions for Use when reprocessing the GIF-1THI90 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE ( GIF-1TH190 ).

Oct 31, 2024 Diagnostic Equipment Nationwide View Details β†’
πŸ₯ Medical Devices Class I - Dangerous

Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601-2-54 and or 21 CFR 1020.32(c) with respect to wired hand switch may fail when being exposed to mechanical stress such as shocks (e.g. dropping) or impacts can irreversibly damage the switching element in the hand switch. A defective switching element may then potentially initiate unintended radiation of the connected mobile X-ray unit.

Aug 8, 2024 Other Medical Devices View Details β†’

GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if applicable) scan modes, after the first image of an exam, each subsequent image can be rotated by an increasing amount. The amount of progressive image rotation is dependent on the gantry speed and the duration of the scan. The final image in the exam can be rotated up to a maximum of ~56 degrees. The entire anatomy rotates as a whole by equal degrees, without distortion, and the anatomical positioning and z-axis of the images remains correct. Small degrees of image rotation might not be noticed. If image rotation is noticed and necessitates a rescan of the patient, the same image rotation will reoccur.

Nov 5, 2024 Other Medical Devices View Details β†’
πŸ₯ Medical Devices Class I - Dangerous

BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.

Oct 31, 2024 Other Medical Devices Nationwide View Details β†’
πŸ₯ Medical Devices Class I - Dangerous

Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601-2-54 and or 21 CFR 1020.32(c) with respect to wired hand switch may fail when being exposed to mechanical stress such as shocks (e.g. dropping) or impacts can irreversibly damage the switching element in the hand switch. A defective switching element may then potentially initiate unintended radiation of the connected mobile X-ray unit.

Aug 8, 2024 Other Medical Devices View Details β†’
πŸ₯ Medical Devices Class I - Dangerous

BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.

Oct 31, 2024 Surgical Instruments Nationwide View Details β†’
πŸ₯ Medical Devices Class I - Dangerous

a. A small number of Fusion Pro 24 units were released with an incorrectly placed Interlock device. As a result, the system can be operated with the front-loading door in an open position. b. Fails to comply with Class 2 designation, indicated in Part 6 of Laser Product Report. An incorrectly placed Interlock device can allow Class 4 laser radiation fields during operation.

Aug 8, 2024 Other Medical Devices Nationwide View Details β†’
πŸ₯ Medical Devices Class I - Dangerous

BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.

Oct 31, 2024 Surgical Instruments Nationwide View Details β†’

Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.

Oct 9, 2024 Other Medical Devices Nationwide View Details β†’

BD identified through potency testing as part of a stability test request to monitor Ampicillin AM-2 due to decrease in potency results of 65% at 18 months, may result in falsely resistant result for ampicillin susceptibility

Nov 6, 2024 Diagnostic Equipment Nationwide View Details β†’
πŸ₯ Medical Devices Class I - Dangerous

BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.

Oct 31, 2024 Other Medical Devices Nationwide View Details β†’

GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if applicable) scan modes, after the first image of an exam, each subsequent image can be rotated by an increasing amount. The amount of progressive image rotation is dependent on the gantry speed and the duration of the scan. The final image in the exam can be rotated up to a maximum of ~56 degrees. The entire anatomy rotates as a whole by equal degrees, without distortion, and the anatomical positioning and z-axis of the images remains correct. Small degrees of image rotation might not be noticed. If image rotation is noticed and necessitates a rescan of the patient, the same image rotation will reoccur.

Nov 5, 2024 Other Medical Devices View Details β†’