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Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

Consumer Safety

Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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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.

Clear
DateProductReasonClassFirm
Dec 7, 2022 Surgical convenience kits labeled as: MEDLINE PLASTICS/PEDS KIT, Reorder Num... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Adult Craniotome Ref: CRANI-A-G1 Intended for cutting and shaping bone i... Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the at... Class II The Anspach Effort, Inc.
Dec 7, 2022 Surgical convenience kits labeled as: MEDLINE SHOULDER SUSPENSION I-LF, Reo... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 IMMULITE 2000 Thyroglobulin (OUS). For in vitro diagnostic use with the IMMUL... Potential for Functional Sensitivity to not meet Instructions For Use (IFU) claims with the kit l... Class II Siemens Healthcare Diagnostics, Inc.
Dec 7, 2022 Surgical convenience kits labeled as: a) MEDLINE PERF. ASSOC. CUT DOWN TRA... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: MEDLINE CABG PACK, Reorder Number DYND... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomogra... Stryker received one report of an injury to an untrained user that occurred while the untrained u... Class II Mobius Imaging, LLC
Dec 7, 2022 Surgical convenience kits labeled as: MEDLINE PAIN TRAY, Reorder Number DYNJ... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 6.5 cm Pediatric Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ S... Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the at... Class II The Anspach Effort, Inc.
Dec 7, 2022 Identity Shoulder System Resection Planer 35mm Resection Planer Two planers were found to be unusable during sawbones shoulder training. Class II Zimmer, Inc.
Dec 6, 2022 Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay... Due to an issue of high coefficient of variability (CV) problem caused by the accuspheres inside ... Class II Future Diagnostics Solutions B.V.
Dec 6, 2022 NexGen Option Stemmed Tibial Component Size 7, Item Number 00-5986-057-01 Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Optio... Class II Zimmer, Inc.
Dec 6, 2022 NexGen Option Stemmed Tibial Component Size 5, Item Number 00-5986-047-01 Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Optio... Class II Zimmer, Inc.
Dec 6, 2022 NexGen Option Stemmed Tibial Component Size 4, Item Number 00-5986-037-02 Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Optio... Class II Zimmer, Inc.
Dec 6, 2022 NexGen Option Stemmed Tibial Component Size 6, Item Number 00-5986-047-02 Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Optio... Class II Zimmer, Inc.
Dec 6, 2022 NexGen Option Stemmed Tibial Component Size 8, Item Number 00-5986-057-02 Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Optio... Class II Zimmer, Inc.
Dec 6, 2022 NexGen Option Stemmed Tibial Component Size 3, Item Number 00-5986-037-01 Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Optio... Class II Zimmer, Inc.
Dec 6, 2022 Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis Device was shipped without having regulatory approval. Class II Stryker Leibinger GmbH & Co. KG
Dec 5, 2022 Oncentra Brachy radiation therapy planning system software. A reconstruction error may occur when using the Catheter Bending functionality in Applicator Mode... Class II Elekta, Inc.
Dec 5, 2022 Agfa HealthCare Enterprise Imaging XERO Viewer There is a software defect that can cause issues with images. Class II Agfa Healthcare NV
Dec 5, 2022 Turbett Surgical Container, TS1200: Indicated for enclosing other medical dev... Pod may have weld failures breaching the sterile barrier and result in the use of unsterile instr... Class II Turbett Surgical, Inc.
Dec 5, 2022 Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 ... 3D orthodontic planning software has a defect that leads to an issue where incorrect number of al... Class II Align Technology Inc
Dec 5, 2022 Turbett Surgical Container, TS1000: Indicated for enclosing other medical dev... Pod may have weld failures breaching the sterile barrier and result in the use of unsterile instr... Class II Turbett Surgical, Inc.
Dec 3, 2022 Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems ... Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502... Class II Medtronic Neuromodulation
Dec 3, 2022 Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems ... Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502... Class II Medtronic Neuromodulation
Dec 3, 2022 Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems ... Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502... Class II Medtronic Neuromodulation
Dec 3, 2022 Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems ... Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502... Class II Medtronic Neuromodulation
Dec 3, 2022 Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems ... Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502... Class II Medtronic Neuromodulation
Dec 2, 2022 Lamaze Chill Teether, Fluid-Filled Teething Ring, Model No. Y5288L Affected lots of the product are being recalled due to potential microbial growth in the fluid in... Class II Tomy International Inc.
Dec 2, 2022 Sofsilk Coated Braided Silk Suture Product Description CS-211 SOFSI... Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic proced... Class II Covidien, LP
Dec 2, 2022 Monosof Monofilament Nylon sutures: Product Description CN-724 MONOSOF* 1... Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic proced... Class II Covidien, LP
Dec 2, 2022 Codman Surgical Patties, Part number 801400; SURG PATXRAY 1/2X1/2-200; Lot 6... Integra LifeSciences identified that one lot was released with out-of-specification endotoxin res... Class II Integra LifeSciences Corp.
Dec 2, 2022 Monofilament Nylon Suture (McKesson Branded) and Coated Braided Silk Suture (... Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic proced... Class II Covidien, LP
Dec 2, 2022 Novafil Monofilament Polybutester Suture Product Description: 8886 4002-41... Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic proced... Class II Covidien, LP
Dec 2, 2022 Surgipro Monofilament Polypropylene Sutures Product Description CP-535 SURG... Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic proced... Class II Covidien, LP
Dec 2, 2022 Surgipro II Monofilament Polypropylene Sutures Product Description Model Num... Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic proced... Class II Covidien, LP
Dec 2, 2022 Surgilon Braided Nylon suture Product Description: 88861883-51 SURGILON* 2-... Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic proced... Class II Covidien, LP
Dec 2, 2022 Dermalon Monofilament Nylon Suture: (1) 88861741-11 DERMALON* 6-0 BLU 45CM... Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic proced... Class II Covidien, LP
Dec 2, 2022 Custom Suture Pack Product Description: US1638 CUSTOM SUTURE PACK US1756 C... Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic proced... Class II Covidien, LP
Dec 2, 2022 Remington MEDICAL, Automatic Cutting Needle, 18ga (1.3mm) x 20cm, REF NAC-182... The stylet is longer than specified on the label Class II Remington Medical, Inc.
Dec 2, 2022 Ti-Cron Coated Braided Polyester Suture Product Description 88862775-31 TIC... Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic proced... Class II Covidien, LP
Dec 2, 2022 Surgidac Uncoated Braided Polyester suture Product Description D-17... Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic proced... Class II Covidien, LP
Nov 30, 2022 Beaver EdgeAhead Stiletto/MVR Knife .90mm Straight (20G)-for ocular paracente... Packaging sterile barrier has been compromised. Open seals can lead to a loss of device sterility... Class II Beaver Visitec International, Inc.
Nov 30, 2022 Source Administration Set (SAS) used with the Medrad Intego PET Infusion Syst... Black specks may be present on the packaged needles Class II Bayer Medical Care, Inc.
Nov 30, 2022 ActiveAid 922, Shower/Commode Chair Device manufactured with a component with affects the foldability of the frame, not allowing it t... Class II Altimate Medical, Inc.
Nov 29, 2022 HeartWare Model 1100 Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ... Class II Heartware, Inc.
Nov 29, 2022 Dual-Trak Clavicle Screws Part Number/Part Description: 40-0136 3.0mm x 80m... Distribution without Pre-Market Clearance Class II Acumed LLC
Nov 29, 2022 HeartWare HVAD Pump Kit, REF 1103 Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ... Class II Heartware, Inc.
Nov 29, 2022 HeartWare HVAD Pump Kit, REF 1104 Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ... Class II Heartware, Inc.
Nov 29, 2022 HeartWare HVAD Pump Kit, REF 1104CA-CLIN Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ... Class II Heartware, Inc.

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.