Browse Device Recalls

35,307 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 35,307 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 35,307 FDA device recalls, Class II.

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DateProductReasonClassFirm
Nov 17, 2022 Sterile Procedural Trays, labeled as the following: a. GYN LAPAROTOMY HA... Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Non-sterile procedural trays labeled as CRANI, 2 per case Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the ... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Non-sterile procedural trays labeled as TOTAL KNEE KIT, 1 per case Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the ... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Sterile Procedural Trays, labeled as the following: LS MS PACK Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Sterile Procedural Trays, labeled as the following: DR MOTT DRAPE PACK Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 TRACH PACK. Sterile Procedural Tray. Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Sterile Procedural Trays, labeled as the following: a. GYN-URO LAPSCP CD... Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 ANCILLARY PACK-LF. Sterile Procedural Tray. Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Sterile Procedural Trays, labeled as the following: a. BASIN SET-UP PACK b.... Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Sterile Procedural Trays, labeled as the following: a. ST. ANNE'S MAJOR B... Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Non-sterile procedural trays labeled as THEDA CLARK TOTAL KNEE CDS, 1 per case Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the ... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Sterile Procedural Trays, labeled as the following: a. KNEE ARTHROSCOPY ... Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Sterile Procedural Trays, labeled as the following: IM NAIL Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Non-sterile procedural trays labeled as LAPAROTOMY CDS, 2 per case Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the ... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Sterile Procedural Trays, labeled as the following: a. PELVISCOPY PACK ... Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Sterile Procedural Trays, labeled as the following: a. SPINAL b. SPINE CDS... Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Non-sterile procedural trays labeled as LAPAROSCOPIC, 2 per case Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the ... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Sterile Procedural Trays, labeled as the following: a. ENDOSCOPY-LF b. S... Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 VITROS Immunodiagnostic Products Intact PTH Reagent Pack- IVD For the quanti... Lower than expected iPTH patient and Quality Control (QC) results, reported negatively biased iPT... Class II Ortho-Clinical Diagnostics, Inc.
Nov 17, 2022 Sterile Procedural Trays, labeled as the following: a. PORT/TRACH INSERTIO... Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Sterile Procedural Trays, labeled as the following: a. BREAST BIOPSY PACK-... Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Sterile Procedural Trays, labeled as the following: a. AV SHUNT CDS b. ... Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Sterile Procedural Trays, labeled as the following: a. MINOR/BREAST BIOPSY... Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATIO... Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 UNIVERSAL CORE DR RUNNELS PACK. Sterile Procedural Tray Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Sterile Procedural Trays, labeled as the following: AMBULATORY MINI PACK Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Sterile Procedural Trays, labeled as the following: a. EAR CDS-LF b. SINUS C... Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Sterile Procedural Trays, labeled as the following: a. C-SECTION OR 30 C... Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Sterile Procedural Trays, labeled as the following: a. EP LAB PACEMAKER PACK... Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 OttLite Rechargeable UVC Disinfecting Wand Product allows for the emission of ultraviolet (UV) electronic product radiation in excess of exp... Class II Ottlite TEchnologies, Inc.
Nov 17, 2022 Sterile Procedural Trays, labeled as the following: a. CELEBRATION ROBOT... Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Sterile Procedural Trays, labeled as the following: a. LAPAROTOMY CDS-LF b. ... Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 LOCAL PACK. Sterile Procedural Tray. Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Sterile Procedural Trays, labeled as the following: a. RHINOPLASTY PACK b... Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 FEMORAL ARTERY PACK-LF. Sterile Procedural Tray Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Sterile Procedural Trays, labeled as the following: a. BASIC EYE PACK-LF... Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Sterile Procedural Trays, labeled as the following: a. UNIVERSAL PLASTIC ... Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Non-sterile procedural trays labeled as MAJOR/MINOR, 3 per case Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the ... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Sterile Procedural Trays, labeled as the following: a. MAJOR CDS-LF b. B... Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Sterile Procedural Trays, labeled as the following: MINOR BASIC PACK-LF Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Non-sterile procedural trays labeled as ORTHO TRAUMA, 1 per case Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the ... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Sterile Procedural Trays, labeled as the following: a. ORAL SURGERY PACK-L... Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Sterile Procedural Trays, labeled as the following: a. GYN ABD CDS b. L... Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 16, 2022 Programmable Diagnostic Computer The firm will be performing a software update to address a software error which affects the liste... Class II Siemens Medical Solutions USA, Inc
Nov 16, 2022 B125M Patient Monitor, REF 6160000-004-XXXXXX GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa"... Class II GE Medical Systems, LLC
Nov 16, 2022 B125P Patient Monitor (with E-module slot option), REF 6160000-002 GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa"... Class II GE Medical Systems, LLC
Nov 16, 2022 PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1 Product C... knot tensile strengths were observed to be significantly below the minimum knot tensile, will res... Class II Ethicon, Inc.
Nov 16, 2022 B105M Patient Monitor, REF 6160000-003 GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa"... Class II GE Medical Systems, LLC
Nov 16, 2022 B125M Patient Monitor, REF 6160000-005-XXXXXXX GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa"... Class II GE Medical Systems, LLC
Nov 16, 2022 B105P Patient Monitor (with E-module slot option), REF 6160000-001-XXXXXX, GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa"... Class II GE Medical Systems, LLC

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.