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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

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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

5,543 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5,543 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 5,543 FDA device recalls.

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DateProductReasonClassFirm
Aug 10, 2015 CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reproc... Advanced Sterilization Products (ASP) is reminding all CIDEX OPA Solution customers to follow the... Class II Advanced Sterilization Products
Aug 5, 2015 Biomet Parsippany, NJ. 4 0 MM X 14 MM Variable Screw C-Tek Maxan Anterior Cer... Some of P/N 14-521614B Lot 375440 was mislabeled as P/N 14-521614 Lot 375440. Class II Biomet Spine, LLC
Jul 31, 2015 AngioJet Spiroflex Thrombectomy Set: Peripheral - UPN 106553-004, Catalog No.... AngioJet products were distributed with an incorrect use-by (expiry) date. The correct date is N... Class II Boston Scientific Corporation
Jul 31, 2015 AngioJet AVX Thrombectomy Set: UPN 105039-001, Catalog No.105039, Sterilized ... AngioJet products were distributed with an incorrect use-by (expiry) date. The correct date is N... Class II Boston Scientific Corporation
Jul 31, 2015 AngioJet SOLENT Omni Thrombectomy Set: UPN 109681-004 & 109681-001, Catalog N... AngioJet products were distributed with an incorrect use-by (expiry) date. The correct date is N... Class II Boston Scientific Corporation
Jul 31, 2015 AngioJet SOLENT Dista Thrombectomy Set: UPN 111303-001, Catalog No. 111303, S... AngioJet products were distributed with an incorrect use-by (expiry) date. The correct date is N... Class II Boston Scientific Corporation
Jul 29, 2015 UCLA Abutment Hexed Castable Cylinder 3.4mm Are accessories to endosseous de... MUCC2, non-hexed, castable abutment cylinders, has been labeled and distributed as a MUCC1C, hexe... Class II Biomet 3i, LLC
Jul 29, 2015 Synthes Trauma Ex-Fix System (Small, Medium, Distraction Osteogenesis (DO) an... Labeling changes were made related to MR conditions that align with standard definitions for MR S... Class II Synthes (USA) Products LLC
Jul 22, 2015 COULTER LH Series Diluent, Catalog No. 8547194, Product Labeling A40192-AD. ... Beckman Coulter is recalling the LH 750 and LH780 Hematology Systems because the use of the dilue... Class II Beckman Coulter Inc.
Jul 21, 2015 Neuro Kinetics, Inc. (NKI) I-Portal¿ NOTC system with the OVAR research test;... The devices that included the OVAR research test were not cleared for marketing and mTBI research... Class II Neuro Kinetics, Inc.
Jul 17, 2015 LYFO Disk LYFO Disk Catalog #0983L is to contain Candida tropicalis. However, lot number 983-40-3 under Cat... Class III Microbiologics Inc
Jul 15, 2015 iChemVELOCITY Automated Urine Chemistry Catalog No. 800-3049, 800-3050, 800-3... Iris International is recalling the iChemVELOCITY systems because they do not maintain the on-boa... Class II Iris Diagnostics
Jul 10, 2015 Stryker Sustainability Solutions CB5LT Ethicon Endo-Surgery, Inc. Excel T... Stryker Sustainability Solutions has received reports indicating that devices from one lot (lot# ... Class II Stryker Sustainability Solutions
Jul 1, 2015 iovera 155 Smart Tip; Catalog numbers:STT0412-10 and STT0412-5 (10 and 5 c... The expiration date on the outer box label and the pouch label for the iovera Smart Tip product i... Class II Myoscience Inc
Jun 29, 2015 ReSolve Locking Drainage Catheters The ReSolve Locking Catheters are inten... Merit Medical Systems, Inc. is voluntarily conducting a recall due to a potential discrepancy bet... Class II Merit Medical Systems, Inc.
Jun 23, 2015 O-Two Adult Ventilation Timer, MODEL #(s): 01BM1000-CS, 01BM3201-MOTP-CS, 01... Malfunction of an O-Two Adult Ventilation Timer, where the flash rate of the malfunctioning devic... Class II O-Two Medical Technologies, Inc.
Jun 19, 2015 Atrium 36Fr Right Angled Firm PVC Thoracic Catheter, (Pkg of 10) Part Number... Inner pouches incorrectly labeled as part 8136, 36Fr Right Angled Thermosensitive PVC catheter, b... Class II Atrium Medical Corporation
Jun 19, 2015 Milex Vaginal-Hymenal Silicone Dilators Set of 4 P/N MX20 Product Usage... Incorrect expiration date on outer carton kit label Class II CooperSurgical, Inc.
Jun 17, 2015 Invivo Expression MRI Patient Monitoring System. The device's labeling inaccurately indicates Endotracheal as a body temperature application site.... Class II Philips Electronics North America Corporation
Jun 17, 2015 Mission -Breath Alcohol Detector -15 tests - 0.08% BAC - Blow bags inc... Acon Laboratories, Inc. is recalling Mission Breath Alcohol Detector due to a labeling amendment. Class III Acon Laboratories, Inc.
Jun 15, 2015 BD Flow Cytometers; used on all BD FACSCount, BD FACSCalibur, BD FACSCanto, B... Instruments installed between June 2007 and September 2011 do not contain labeling pursuant to th... Class III BD Biosciences, Systems & Reagents
Jun 12, 2015 On-X Prosthetic Heart Valve Product Usage: Indicated for the replacement ... Incorrect product label. The type of Sewing Ring was mislabeled as being a Standard Sewing Ring ... Class II CryoLife, Inc.
Jun 10, 2015 Carepak Sheer Adhesive Bandages 50 Sterile Bandages Assorted Sizes Contain 0.1% Benzalkonium Chloride in the 5/8 bandages inside the assortment which is not listed ... Class II ASO, LLC
Jun 8, 2015 Natrelle Re-sterilizable Breast Implant Sizer, Size: 410 cc, Style No. MSZFX4... Allergan is recalling the NATRELLE 410cc Re-Sterilizable Breast Implant Sizer because the expired... Class II Allergan Inc
Jun 4, 2015 Volcano PV .035 Catheter: Part number: 88901; Product Usage: The Volcano... During a relabeling procedure at the manufacturing facility, the products were labeled with a she... Class II Volcano Corporation
Jun 4, 2015 Merit Medical Prelude Pro Sheath Introducter, 6F (2.0mm) 11cm, REF PRO-6F-11-... Some of these introducer sheaths were packaged with a 0.035 inch dilator, rather than the labeled... Class II Merit Medical Systems, Inc.
Jun 4, 2015 Prestige Plus 185cm J-Tip: Part number: 9185J; Product Usage: The Presti... During a relabeling procedure at the manufacturing facility, the products were labeled with a she... Class II Volcano Corporation
Jun 3, 2015 WIZARD2 5-detector, 550 samples Product Code: 2470-0050, 3470-0050 The Wi... Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results Class II Perkinelmer
Jun 3, 2015 WIZARD2 2-detector, 550 samples Product Code: 2470-0020 The Wizard¿" gamm... Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results Class II Perkinelmer
Jun 3, 2015 Perkin Elmer WIZARD2 10-detector, 1000 samples Product Code: 2470-0200, 3470... Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results Class II Perkinelmer
Jun 3, 2015 Perkin Elmer WIZARD2 1-detector, 550 samples Product Code: 2470-0010 The ... Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results Class II Perkinelmer
Jun 3, 2015 Perkin Elmer WIZARD2 5-detector, 1 000 samples Product Code: 2470-0150, 3470... Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results Class II Perkinelmer
Jun 3, 2015 Perkin Elmer WIZARD2 1-detector,3", 1000 samples Product Code: 2480-0010 ... Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results Class II Perkinelmer
Jun 3, 2015 Perkin Elmer WIZARD2 10-detector, 550 samples Product Code: 2470-0100, 3470-... Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results Class II Perkinelmer
May 29, 2015 Songer Spinal Cable System, Single Cable, Crimp, Bar, Stainless Steel, Steril... The box end label is incorrectly labeled as Titanium instead of Stainless Steel on one lot of imp... Class II RTI Surgical, Inc. (dba Pioneer Surgical Techno...
May 29, 2015 Stryker Orthopaedics Triathlon X3 Tibial Bearing Insert - CR REF 5530-G-209 ... Stryker has received a report which identified that a Triathlon Tibial Bearing Insert CS X3 Size ... Class II Stryker Howmedica Osteonics Corp.
May 29, 2015 Triathlon PS X3 Tibial Insert; No. 3 Triathlon TS Plus Tibial Insert X3 Poly ... Stryker Orthopaedics received a report that 5537-G-319 No 3. Triathlon TS Plus Tibial Insert X3 P... Class II Stryker Howmedica Osteonics Corp.
May 27, 2015 PowerPICC SOLO Catheter with Sherlock 3CG TPS Stylet 4F Maximal Barrier Tray ... Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates o... Class III Bard Access Systems
May 27, 2015 PowerPICC SOLO2 Catheter 4F Maximal Barrier Tray with Microintroducer (Single... Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates o... Class III Bard Access Systems
May 27, 2015 PowerPICC SOLO Catheter with Sherlock 3CG (TPS) Stylet 5F Maximal Barrier Tra... Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates o... Class III Bard Access Systems
May 27, 2015 Allofix Insertion Kit, 2.0 mm, Single Drill, Product Usage: MTF Surgical... Musculoskeletal Transplant Foundation is recalling a certain lot of Allofix Insertion Kits becaus... Class II Musculoskeletal Transplant Foundation, Inc.
May 27, 2015 Cortical Pin 2.0 mm,Sterile, FREEZE DRIED: Store at ambient temperature. Do ... Musculoskeletal Transplant Foundation (MTF) is recalling one lot of MTF's Allograft Cortical Pins... Class II Musculoskeletal Transplant Foundation, Inc.
May 27, 2015 PowerPICC SOLO Catheter with Tip Location System (TLS) Stylet 4F Nurse Full T... Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates o... Class III Bard Access Systems
May 21, 2015 Bullet-Tip PEEK VBR/IBF System, 32mm(l) 13mm(H) Implant 32-13-32 UDI (01)0084... Three lots of the Bullet -Tip VBR 13mm x 32 mm implants are mislabeled with a light green colored... Class II RTI Surgical, Inc. (dba Pioneer Surgical Techno...
May 20, 2015 MILEX OMNIFLEX DIAPHRAGM SIZE 80 Model: MXWF80 A diaphragm size 80 labeled box was incorrectly packaged with a size 85. Class II CooperSurgical, Inc.
May 18, 2015 ORTHOFIX Firebird Spinal Fixation System 6.5mm x 55mm Multi-Axial Screw, Sta... The Firebird Spinal Fixation System 6.5 mm x 55 mm Bone Screw, Self-Tapping is currently mislabel... Class II Orthofix, Inc
May 15, 2015 Gelseal Straight Diameter 8mm Length 30cm. Vascular graft prosthesis is an... Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft. Class II Vascutek, Ltd.
May 15, 2015 Gelseal Straight Diameter 8mm Length 15cm. Vascular graft prosthesis is an... Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft. Class II Vascutek, Ltd.
May 13, 2015 The spare component Anti-HBs Cutoff Calibrator, 10 mLU/mL, Catalog number 261... The spare component Anti-HBs Cutoff Calibrator, Catalog number 26154, is recalled because the exp... Class III Bio-Rad Laboratories, Inc.
May 13, 2015 3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the C... Certain lots of the 3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws were foun... Class II Synthes, 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.