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Vehicle Safety

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

Infrastructure

Bridge Safety624,000 bridge inspections Aviation Safety30,000+ NTSB aviation events Dam Safety92,600 dam safety records Water Safety433,000+ public water systems Railroad Safety438,000+ rail crossings Pipeline Safety8,800+ pipeline incidents State DashboardsSafety grades for all 50 states ZIP ReportAny 5-digit ZIP across 9 datasets

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Browse Device Recalls

1,683 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,683 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 1,683 FDA device recalls in 2026.

Clear
DateProductReasonClassFirm
May 21, 2026 GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 000554075... The active ingredient concentration in the lysing bag solution of specific GEM Premier 5000 lots ... Class II Instrumentation Laboratory
May 21, 2026 Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain exp... Flexible hysteroscopes indicated for use during diagnostic and operative hysteroscopic procedures... Class II Karl Storz Endoscopy
May 21, 2026 Papablic Replacement Brush Heads. Model Number: Papablic18B Potential for brush heads to break. Class II Papablic Inc
May 21, 2026 Papablic Replacement Brush Heads. Model Number: PAPA317AA. Potential for brush heads to break. Class II Papablic Inc
May 21, 2026 Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Cata... There have been reports of air and medication leakage from the nebulizer cup during therapy of Vo... Class I Baxter Healthcare Corporation
May 21, 2026 Medline Convenience Kits: 1) L&D CONTINUOUS EPIDURAL TRAY, Model Number: PAI... The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(... Class II Medline Industries, LP
May 21, 2026 Medline Convenience Kits: 1) MULTIMED, 7FR, 20CM, 3L, CVC BUNDLE, Model Numb... The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(... Class II Medline Industries, LP
May 21, 2026 Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catal... There have been reports of air and medication leakage from the nebulizer cup during therapy of Vo... Class I Baxter Healthcare Corporation
May 21, 2026 5605150 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lu... Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufactu... Class II Bard Access Systems, Inc.
May 21, 2026 CRE Pro Wireguided 18-20mm 240cm Potential sterile breach of the pouches in which devices are packaged. Class II Boston Scientific Corporation
May 21, 2026 A M S, ALIGNED MEDICAL SOLUTIONS, Preop Kit-NS, Pack Number AMS18227, surgica... Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the d... Class I Windstone Medical Packaging, Inc.
May 21, 2026 A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgi... Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the d... Class I Windstone Medical Packaging, Inc.
May 21, 2026 1174108 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741154935 ... Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufactu... Class II Bard Access Systems, Inc.
May 21, 2026 CRE Wireguided 10-12mm 240cm Potential sterile breach of the pouches in which devices are packaged. Class II Boston Scientific Corporation
May 21, 2026 Solar GI System (Water Perfusion); Product Name (Catalog Number): Solar GI ... Under extended clinical use conditions (e.g., long duration studies), moisture generated within t... Class II Laborie Medical Technologies Corp
May 21, 2026 Medline Convenience Kits: 1) MERCY MEDICAL CIRCUMCISION TRAY, Model Number: ... The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(... Class II Medline Industries, LP
May 21, 2026 Medline Convenience Kits: 1) ARTERIAL LINE KIT, Model Number: ART890B; 2) ... The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(... Class II Medline Industries, LP
May 21, 2026 4380 ECONOMY SOFT TISSUE BIOPSY TRAY UDI-DI Code: 0110885403108563 4382A ... Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufactu... Class II Bard Access Systems, Inc.
May 21, 2026 CRE Pro Wireguided 8-10mm 240cm Potential sterile breach of the pouches in which devices are packaged. Class II Boston Scientific Corporation
May 21, 2026 Medline Convenience Kits: 1) OPHTHALMIC PACK W/LIDO, Model Number: DYNJ57922A The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(... Class II Medline Industries, LP
May 21, 2026 CRE Wireguided 18-20mm 240cm Potential sterile breach of the pouches in which devices are packaged. Class II Boston Scientific Corporation
May 21, 2026 CK000980A PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741236150 ... Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufactu... Class II Bard Access Systems, Inc.
May 21, 2026 CRE Wireguided 6-8mm 240cm Potential sterile breach of the pouches in which devices are packaged. Class II Boston Scientific Corporation
May 21, 2026 7617408 Groshong NXT ClearVue Catheter 4 Fr Single-Lumen UDI-DI Code: 008017... Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufactu... Class II Bard Access Systems, Inc.
May 21, 2026 Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/... There have been reports of air and medication leakage from the nebulizer cup during therapy of Vo... Class I Baxter Healthcare Corporation
May 21, 2026 A M S, ALIGNED MEDICAL SOLUTIONS, Thyroid FNA Pack-RX, Pack Number AMS17729, ... Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the d... Class I Windstone Medical Packaging, Inc.
May 21, 2026 OTP5000 THORA/PARA TRAY, 5FR, NON-VALVED UDI-DI Code: 0110885403284748 PI... Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufactu... Class II Bard Access Systems, Inc.
May 21, 2026 A M S, ALIGNED MEDICAL SOLUTIONS, Dr. Lewin Pack, Pack Number AMS7200D, surgi... Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the d... Class I Windstone Medical Packaging, Inc.
May 21, 2026 Medline Convenience Kits: 1) BLOCK TRAY, Model Number: DYNJRA1590 The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(... Class II Medline Industries, LP
May 21, 2026 CRE Wireguided 15-18mm 240cm Potential sterile breach of the pouches in which devices are packaged. Class II Boston Scientific Corporation
May 21, 2026 CRE Wireguided 12-15mm 240cm Potential sterile breach of the pouches in which devices are packaged. Class II Boston Scientific Corporation
May 21, 2026 Medline Convenience Kits: 1) LUMBAR PUNCTURE CHOICE, Model Number: DYNDH1215 The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(... Class II Medline Industries, LP
May 21, 2026 CK000662 PowerPICC SOLO HF Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741... Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufactu... Class II Bard Access Systems, Inc.
May 21, 2026 CRE Wireguided 8-10mm 240cm Potential sterile breach of the pouches in which devices are packaged. Class II Boston Scientific Corporation
May 21, 2026 Medline Convenience Kits: 1) ARTERIAL ACCESS TRAY W/LIDOCAINE, Model Number:... The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(... Class II Medline Industries, LP
May 21, 2026 CRE Pro Wireguided 6-8mm 240cm Potential sterile breach of the pouches in which devices are packaged. Class II Boston Scientific Corporation
May 21, 2026 CRE Pro Wireguided 15-18mm 240cm Potential sterile breach of the pouches in which devices are packaged. Class II Boston Scientific Corporation
May 21, 2026 1274108D PowerPICC SV Catheter 4 Fr Dual-Lumen REKW2449 00801741087110 31731... Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufactu... Class II Bard Access Systems, Inc.
May 21, 2026 CRE Pro Wireguided 10-12mm 240cm Potential sterile breach of the pouches in which devices are packaged. Class II Boston Scientific Corporation
May 21, 2026 Medline Convenience Kits: 1) PAIN MGMT/ PREF W. MED NDL, Model Number: PAIN00... The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(... Class II Medline Industries, LP
May 21, 2026 Medline Convenience Kits: 1) DYNJ0621189X, Model Number: SM RADIOLOGY-ANGIO ... The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(... Class II Medline Industries, LP
May 21, 2026 Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Ca... There have been reports of air and medication leakage from the nebulizer cup during therapy of Vo... Class I Baxter Healthcare Corporation
May 21, 2026 CK000525B PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801... Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufactu... Class II Bard Access Systems, Inc.
May 21, 2026 5625240 DuoGlide Short-Term Straight Dialysis Catheter 13 Fr Dual-Lumen UDI-... Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufactu... Class II Bard Access Systems, Inc.
May 21, 2026 CK000880 Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 0080174118877... Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufactu... Class II Bard Access Systems, Inc.
May 21, 2026 Medline Convenience Kits: 1) SUTURING SET, Model Number: SUT13710 The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(... Class II Medline Industries, LP
May 21, 2026 Medline Convenience Kits: 1) PI CVC KIT 3L 7 FR 16 CM, Model Number: ECVC8520... The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(... Class II Medline Industries, LP
May 21, 2026 CK000727 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741138478... Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufactu... Class II Bard Access Systems, Inc.
May 21, 2026 Medline Convenience Kits: 1) IMAGING BIOPSY TRAY, Model Number: DYNDH1068; ... The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(... Class II Medline Industries, LP
May 21, 2026 Medline Convenience Kits: 1) STD, INTRO-FLEX INTRODUCER 6F, C, Model Number:... The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(... Class II Medline Industries, LP

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.