Browse Device Recalls

1,001 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,001 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 1,001 FDA device recalls.

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DateProductReasonClassFirm
Sep 4, 2024 Medline brand medical procedure convenience kits, labeled as: a) OB PACK-L... It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 4, 2024 Medline brand medical procedure convenience kits, labeled as: a) KIT LINE ... It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 4, 2024 Medline PEDIATRIC DRAPE PK, REF DYNJ81297; medical procedure convenience kit It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 4, 2024 Medline brand medical procedure convenience kits, labeled as: a) NEURO PAC... It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 4, 2024 Medline brand medical procedure convenience kits, labeled as: 1) T&A CDS-L... It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 4, 2024 Medline brand, medical procedure convenience kits, labeled as: a) SET UP PAC... It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 4, 2024 Medline brand medical procedure convenience kits, labeled as: 1) CYSTO CDS... It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 4, 2024 Medline brand medical procedure convenience kits, labeled as: 1) L&D/OB PACK... It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 4, 2024 Medline brand medical procedure convenience kits, labeled as: a) ABDOMINAL... It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 4, 2024 Medline IV TEAM PICC, REF DYNJ48222; medical procedure convenience kit It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 4, 2024 Medline brand medical procedure convenience kits, labeled as: a) UNIVERSAL... It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 4, 2024 Medline brand, medical procedure convenience kits, labeled as: a) RADIOLOG... It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 4, 2024 Centurion PEDIATRIC/ADULT TRACHEOSTOMY T, REF TC7895; medical procedure conve... It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 4, 2024 Medline brand medical procedure convenience kits, labeled as: 1) THORACENTESI... XXX Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 4, 2024 Medline TUBAL LIGATION PACK, REF DYNJ66230B; medical procedure convenience kit It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 4, 2024 Medline CENTRAL CATHETER INSERTION TRA, REF CVI680C; medical procedure conven... It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 4, 2024 Centurion EP LAB INSTRUMENT KIT, REF MNS10480; medical procedure convenience kit It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 4, 2024 Medline DIALYSIS PACK, REF DYNJ36932A; medical procedure convenience kit It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 4, 2024 Medline brand medical procedure convenience kit, labeled as: a) PAIN PROCEDU... It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 4, 2024 Medline brand medical procedure convenience kits, labeled as: 1) EYE PACK, ... It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 4, 2024 Medline brand medical procedure convenience kits, labeled as: 1) NEW LONDO... It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 4, 2024 Medline AMBULATORY MINI PACK, REF DYNJ82579; medical procedure convenience kit It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 4, 2024 Medline EYE PACK, REF LYN036EPESB; medical procedure convenience kit It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 4, 2024 Centurion OB TRAY, REF MNS13965A; medical procedure convenience kit It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 4, 2024 Medline brand, medical procedure convenience kits, labeled as: a) CUH OPEN... It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 4, 2024 Medline DENTAL PACK, REF DYNJ64086B; medical procedure convenience kit It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 4, 2024 Medline CHEST TUBE INSERTION TRAY ADUL, REF CHT1165; medical procedure conven... It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 4, 2024 Medline brand medical procedure convenience kits, labeled as: a) TRAY ADD ... It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 4, 2024 Medline brand medical procedure convenience kits, labeled as: a) PLASTIC P... It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 4, 2024 Medline brand medical procedure convenience kits, labeled as: a) LITHOTOMY... It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 3, 2024 (1) Centurion Sterile CirClamp, Reorder #200CR; (2) Centurion CirClamp with ... Product has been identified as having holes in the packaging. Class II MEDLINE INDUSTRIES, LP - Northfield
Aug 30, 2024 MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001 It has been determined that certain Blood Pressure Monitors containing a faulty microchip have fa... Class II MEDLINE INDUSTRIES, LP - Northfield
Aug 30, 2024 MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U. It has been determined that certain Blood Pressure Monitors containing a faulty microchip have fa... Class II MEDLINE INDUSTRIES, LP - Northfield
Aug 30, 2024 MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT. It has been determined that certain Blood Pressure Monitors containing a faulty microchip have fa... Class II MEDLINE INDUSTRIES, LP - Northfield
Aug 28, 2024 MEDLINE OPEN HEART NIMC KIT, REF DYNJ908840 Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the... Class II MEDLINE INDUSTRIES, LP - Northfield
Aug 28, 2024 MEDLINE HEART OVERHEAD TABLE PACK, REF DYNJ0778508J Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the... Class II MEDLINE INDUSTRIES, LP - Northfield
Aug 28, 2024 MEDLINE HEART CABG CDS, REF CDS983376R Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the... Class II MEDLINE INDUSTRIES, LP - Northfield
Aug 28, 2024 Medline Sterile Laparoscopy Pack, DYNJ68187A (REF), containing the component ... CONMED Corporation (vendor) initiated a recall for select lot numbers of the Unimax Detachable En... Class II MEDLINE INDUSTRIES, LP - Northfield
Aug 28, 2024 MEDLINE OPEN HEART PACK, REF DYNJ66216C Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the... Class II MEDLINE INDUSTRIES, LP - Northfield
Aug 28, 2024 MEDLINE OPEN HEART, REF DYNJ904261B Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the... Class II MEDLINE INDUSTRIES, LP - Northfield
Aug 28, 2024 MEDLINE KIT CV I II, REF DYNJ906071B Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the... Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 27, 2024 Medline convenience kits containing semi-rigid suction liners labeled as foll... Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 27, 2024 Medline convenience kits containing semi-rigid suction liners labeled as foll... Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 27, 2024 Medline convenience kits containing semi-rigid suction liners labeled as foll... Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 27, 2024 Medline convenience kits containing semi-rigid suction liners labeled as foll... Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 27, 2024 Medline convenience kits containing semi-rigid suction liners labeled as foll... Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 27, 2024 Medline convenience kits containing semi-rigid suction liners labeled as foll... Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 27, 2024 Medline Semi-rigid suction liners labeled as follows: a) SEMI RIGID SUCTION ... Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 27, 2024 Medline convenience kits containing semi-rigid suction liners labeled as foll... Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 27, 2024 Medline convenience kits containing semi-rigid suction liners labeled as foll... Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... Class II MEDLINE INDUSTRIES, LP - Northfield

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.