Browse Device Recalls

3,133 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,133 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 3,133 FDA device recalls.

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DateProductReasonClassFirm
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. 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 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 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: 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 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 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. 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 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 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. 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 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: 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 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 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 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 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 Sterile Procedural Tray, labeled as the following: a. PAIN SERVICE 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. CARDIAC CATH 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: GENERAL ENDOSCOPY 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. WOUND CLOSURE 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 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 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 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: 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 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 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. 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 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 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. 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 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. 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 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. 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 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. 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: 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 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: 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 8, 2022 9 Gauge Disposable Trocars with Blunt Pushers for Use with Subcutaneous Impla... No expiration dates printed on the packaging Class II ENDO Pharmaceuticals Solutions, Inc.
Nov 7, 2022 Tobra Full Dose CE Antibiotic Simplex P- Indicated for the fixation of prosth... Instructions for Use (IFU) included in the packaging is missing a translation in the Turkish lan... Class III Howmedica Osteonics Corp.
Nov 7, 2022 Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of pro... Instructions for Use (IFU) included in the packaging is missing a translation in the Turkish lan... Class III Howmedica Osteonics Corp.
Nov 1, 2022 NUVASIVE MAGEC MAGEC 2 Rod. The MAGEC System is used to brace the spine dur... During accelerated shelf-life extension studies it was noted that the final packaging was experie... Class II NuVasive Specialized Orthopedics, Inc.
Nov 1, 2022 Various Custom Surgical Instrument Disposable Kits: Part Numbers / Product D... Due to Customer Convenience Kits containing 3M Steri-Drape Surgical Drapes that have been recalle... Class II Windstone Medical Packaging, Inc.
Oct 31, 2022 Unity Total Knee System. Used for knee prosthesis in total knee replacement The internal packaging system for devices may have damage to the blisters potentially damaging th... Class II Corin Ltd
Oct 28, 2022 EVOLUTION MP Tibial Bases, Size 2+ LEFT, REF ETPKN2PL, knee tibial base One confirmed incident has been received that ETPKN2PL lot 1916559, size 2 Evolution MP Tibial Ba... Class II MicroPort Orthopedics Inc.
Oct 28, 2022 EVOLUTION MP Tibial Bases, Size 7 LEFT, REF ETPKN7SL, knee tibial base One confirmed incident has been received that ETPKN2PL lot 1916559, size 2 Evolution MP Tibial Ba... Class II MicroPort Orthopedics Inc.
Aug 30, 2022 Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001 Drill Pin (drill bit) is not compatible with the Drill Template included in the kit due to a pack... Class II Synthes (USA) Products LLC
Aug 16, 2022 Cope Mandril Wire Guide (Nitinol), Nitinol Guidewire; Reference Part Number/... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated

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.