All Recalls

92,900 total recalls in our database

Potential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Temperatures higher than specification may lead to the potential for minor tissue/structure damage or tissue/structure damage from thermal injury which may need medical/surgical intervention.

Jul 24, 2024 Other Medical Devices Nationwide View Details →

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Apr 8, 2024 Surgical Instruments View Details →

Medline procedural kits labeled as: 1) OPEN HEART PEDS, Pack Number CDS981050Q; 2) OPEN HEART CDS, Pack Number CDS982411N; 3) OPEN HEART, Pack Number CDS983348AA; 4) OPEN HEART, Pack Number CDS983348X; 5) OPEN HEART, Pack Number CDS983348Y; 6) HMT CV SET UP CDS, Pack Number CDS984206R; 7) OPEN HEART PEDS PACK, Pack Number CMPJ01037P; 8) OPEN HEART A&B PACK, Pack Number CMPJ02162I; 9) HMT SMALL TABLE PACK, Pack Number CMPJ03510J; 10) MAJOR VASCULAR PACK, Pack Number CMPJ06631C; 11) VASCULAR PACK, Pack Number CMPJ08949F; 12) BOISE HEART PACK-LF, Pack Number CMPJ09225F; 13) VASCULAR PACK, Pack Number CMPJ09236D; 14) VASCULAR/OR ANGIO PACK, Pack Number CMPJ09236F; 15) CAROTID ENDARTERECTOMY PACK, Pack Number CMPJ09400C; 16) CAROTID PACK, Pack Number CMPJ10797B; 17) CAROTID ENDARTERECTOMY, Pack Number CMPJ10985A; 18) CAROTID ENDARTERECTOMY, Pack Number CMPJ10985B; 19) VASCULAR PACK, Pack Number CMPJ13632; 20) OPEN HEART DRAPE PACK-LF, Pack Number DYNJ0382048M; 21) CABG PACK-LF, Pack Number DYNJ0824648K; 22) HEART PEDIATRIC PACK-LF, Pack Number DYNJ16541R; 23) ADULT CARDIO TRAY, Pack Number DYNJ35495G; 24) ADULT CARDIO TRAY, Pack Number DYNJ35495G; 25) PEDIATRIC CARDIO CATH PACK, Pack Number DYNJ35578G; 26) MAJOR VASCULAR PACK, Pack Number DYNJ38318F; 27) MAJOR VASCULAR PACK, Pack Number DYNJ38318G; 28) EP PACER PACK, Pack Number DYNJ38863N; 29) EP PACER PACK, Pack Number DYNJ38863O; 30) PERFUSION SYRINGE, Pack Number DYNJ39223C; 31) VASCULAR PACK, Pack Number DYNJ39525; 32) VASCULAR ADD ON PACK, Pack Number DYNJ44420C; 33) SHUNT ENDARTERECTOMY, Pack Number DYNJ44565D; 34) VASCULAR ACCESS PACK, Pack Number DYNJ56510A; 35) HEART VALVE PACK, Pack Number DYNJ58365J; 36) RIGHT HEART PACK MOSES, Pack Number DYNJ58873A; 37) GENERAL VASCULAR PACK, Pack Number DYNJ60177A; 38) PK CUST PERIPHERAL VASCUL, Pack Number DYNJ60904A; 39) PK CUST PERIPHERAL VASCUL, Pack Number DYNJ60904B; 40) PK CUST PERIPHERAL VASCUL, Pack Number DYNJ60904C; 41) PK, VASCULAR-MAJOR, Pack Number DYNJ61603A; 42) VASCULAR PACK, Pack Number DYNJ63182A; 43) VASCULAR SHARED, Pack Number DYNJ64801B; 44) VASCULAR PACK, Pack Number DYNJ65160; 45) VASCULAR DSC, Pack Number DYNJ69172B; 46) OPEN HEART PACK, Pack Number DYNJ83695; 47) WMC HYBRID OR, Pack Number DYNJ904036J; 48) VASCULAR, Pack Number DYNJ904845G; 49) BOISE HEART, Pack Number DYNJ905070I; 50) VASCULAR/OR ANGIO, Pack Number DYNJ905079F; 51) VASCULAR PACK, Pack Number DYNJ905226D; 52) CAROTID, Pack Number DYNJ906561F; 53) CAROTID ENDARTERECTOMY, Pack Number DYNJ906744A; 54) CAROTID ENDARTERECTOMY, Pack Number DYNJ906744B; 55) UNIVERSITY VASCULAR, Pack Number DYNJ907201B; 56) KIT OPEN HEART, Pack Number DYNJ908603B; 57) VASCULAR PACK, Pack Number DYNJ909374; 58) ISLET CELL UNIV OF IL, Pack Number DYNJ909768; 59) ADULT CORONARY PACK, Pack Number DYNJV0275J; 60) ADULT CORONARY PACK, Pack Number DYNJV0275K; 61) ADULT CORONARY PACK, Pack Number DYNJV0275M; 62) ADULT CORONARY PACK, Pack Number DYNJV0275N

MEDLINE INDUSTRIES, LP - Northfield

🏥 Medical Devices Class I - Dangerous

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Apr 8, 2024 Surgical Instruments View Details →

Centurion procedure kits labeled as: 1) 3" RADIAL ARTERIAL LINE KIT- ICU, Pack Number ART240B; 2) 5FR 2L PICC LINE TRAY, Pack Number PICC0020; 3) 6" FEMORAL ARTERIAL LINE KIT, Pack Number ART245B; 4) ADVANCED REPAIR KIT, Pack Number SUT15940; 5) ARTHROGRAM TRAY, Pack Number SPEC0004C; 6) ARTHROGRAM TRAY, Pack Number DYNDH1134; 7) ARTHROGRAM TRAY-LF, Pack Number SPEC0400; 8) ARTHROGRAM/LP/MYELOGRAM TRAY, Pack Number PT220; 9) AULTMAN HOSPITAL CHEST TUBE INSERTION TR, Pack Number CHT500; 10) BIOPSY BASIC PACK, Pack Number P784604; 11) BIOPSY KIT, Pack Number DYNDA1466A; 12) BIOPSY SKIN/LACERATION TRAY, Pack Number SUT20455; 13) BIOPSY TRAY, Pack Number BT1015; 14) BIOPSY TRAY, Pack Number DYNDH1273; 15) BIOPSY TRAY, Pack Number BT1060; 16) BIOPSY TRAY, Pack Number DYNDH1340; 17) BIOPSY TRAY, Pack Number P151659; 18) BIOPSY TRAY, Pack Number SPEC0292; 19) BIOPSY TRAY, Pack Number DYNDH1314A; 20) BIOPSY TRAY, Pack Number DYNDH1137C; 21) BIOPSY TRAY - LF, Pack Number DYNJTS0018A; 22) BIOPSY TRAY-LF, Pack Number SPEC4380; 23) BIOPSY/ARTHROGRAM TRAY, Pack Number DYNDH1115; 24) BONE MARROW BIOPSY ASPIRATION, Pack Number DYNJTS0214; 25) BREAST BIOPSY TRAY, Pack Number SPEC0130C; 26) CATHETER ON/OFF KIT, Pack Number DT5490B; 27) CDP, INTRODUCER KIT 9F, Pack Number S5078BF09; 28) CHEST TUBE INSERTION TRAY, Pack Number CHT705; 29) CHEST TUBE INSERTION TRAY, Pack Number CHT1900; 30) CHEST TUBE, UMBI LINE PK, Pack Number DYNDA1432A; 31) CIRCUMCISION TRAY, Pack Number CIT6260; 32) CIRCUMCISION/MINOR TRAY, Pack Number CIT6785A; 33) CONGENITAL ADD-ON KIT, Pack Number DYNDA2213A; 34) CORE BIOPSY TRAY, Pack Number SPEC0083B; 35) CT BIOPSY TRAY W/CHLORAPREP, Pack Number DYNJ05162; 36) CUSTOM BIOPSY TRAY, Pack Number MNS4815; 37) CUSTOM BX TRAY, Pack Number SPEC0071B; 38) DELIVERY ACCESSORY KIT, Pack Number MNS6496; 39) DIAGNOSTIC TRAY, Pack Number DYNDH1359; 40) E. R. LACERATION TRAY, Pack Number DYNDL1187A; 41) ER CHEST TUBE TRAY, Pack Number CHT1570A; 42) ER LACERATION TRAY C WEST, Pack Number DYNDL2952; 43) FACET BLOCK TRAY-AVERY MELVIN, Pack Number DYNJRA0421; 44) FINE LACERATION KIT, Pack Number SUT19360; 45) FINE LACERATION KIT, Pack Number SUT17215; 46) HH PACK BIOPSY, Pack Number BT345; 47) HSG TRAY, Pack Number DYNDH1453; 48) I&D TRAY, Pack Number ID2165; 49) INCISION & DRAINAGE TRAY, Pack Number ID2060; 50) INFECTION DRIVELINE MANAGEMENT KIT, Pack Number DM645; 51) I-PACK INJECTION KIT WITH DRAPE, Pack Number MNS12150; 52) ISHAK I.R. BIOPSY TRAY, Pack Number DYNDH1297; 53) LACERATION TRAY, Pack Number SUT20955; 54) LACERATION TRAY, Pack Number DYNDL1772; 55) LACERATION TRAY, Pack Number DYNDL1250C; 56) LACERATION TRAY, Pack Number DYNDL1887; 57) LACERATION TRAY, Pack Number SUT3780; 58) LACERATION TRAY, Pack Number DYNDL1774A; 59) LACERATION TRAY, Pack Number SUT18080; 60) LACERATION TRAY, Pack Number SUT21490; 61) LOCAL INFILTRATION TRAY, Pack Number DYNDH1406; 62) LUMBAR EPIDURAL TRAY-LF, Pack Number DYNJRA0313B; 63) LUMBAR PUNCTURE TRAY, Pack Number DYNDH1321; 64) LUMBAR PUNCTURE TRAY, Pack Number SPEC0289; 65) LUMBAR PUNCTURE TRAY, Pack Number PT215; 66) LUMBAR TRAY, Pack Number SPEC0177; 67) LUMBAR TRAY, Pack Number DYNDH1540A; 68) MAMMOGRAPHY BIOPSY TRAY, Pack Number DYNDH1304A; 69) MINI INTERVENTIONAL PACK, Pack Number DYNDH1324; 70) MYELO / ARTHRO TRAY, Pack Number DYNDH1332A; 71) MYELOGRAM TRAY, Pack Number DYNJTS0516A; 72) MYELOGRAM TRAY, Pack Number DYNJTS0514; 73) MYELOGRAM TRAY, Pack Number DYNDH1531; 74) OB DELIVERY SET, Pack Number MNS3355; 75) OB DELIVERY TRAY, Pack Number MNS5575; 76) OHS CT BIOPSY TRAY -LF, Pack Number DYNDH1270; 77) ONCOLOGY-HEMOTOLOGY PREP TRAY-STERILE/LF, Pack Number DYNDA2523; 78) PACEMAKER TRAY, Pack Number MNS12700; 79) PACEMAKER TRAY, Pack Number MNS12625; 80) PACEMAKER TRAY, Pack Number MNS12700A; 81) PACK,CHALAZION SEY59CHCHA, Pack Number DYNDL1571B; 82) PEDI ULTRASOUND GUIDED PIV KIT, Pack Number IVS3320; 83)

MEDLINE INDUSTRIES, LP - Northfield

🏥 Medical Devices Class I - Dangerous

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Apr 8, 2024 Implants & Prosthetics View Details →

Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.

May 29, 2024 Other Medical Devices View Details →

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Apr 8, 2024 Surgical Instruments View Details →

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Apr 8, 2024 Surgical Instruments View Details →