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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

1,515 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,515 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 1,515 FDA device recalls.

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DateProductReasonClassFirm
Sep 24, 2014 Discovery Elbow Humeral Trial Product Usage: Biomet manufactures a varie... An investigation identified that the product was incorrectly manufactured as a left humeral trial... Class II Biomet, Inc.
Sep 17, 2014 Compress Face Reamer Product Usage: Correction of revision of unsuccess... Investigation determined that units supplied were missing the 4x21 degree helix angle. Class II Biomet, Inc.
Sep 5, 2014 ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled ele... The software issue described was corrected in the modification to the MXTTOUT controller paramete... Class II Zimmer Biomet, Inc.
Jul 1, 2014 Vanguard 360 Femoral Boss Reamer, Label: REF 32-488474 VANGUARD 360 1NSTRU... The Vanguard 360 Femoral Boss Reamers were manufactured oversized to the print. The instrument ma... Class II Biomet, Inc.
Jun 25, 2014 BIOMET 3i Certain Bellatek Encode Healing Abutment Biomet 3i Healing abut... Identifiers on the label are correct but the label has the incorrect color coding. Class II Biomet 3i, LLC
Jun 23, 2014 Device Brand Name: Distal Radius Fracture Repair System Device Classificatio... The firm received complaints indicating that the drill guide becomes stuck in the jig. The drill ... Class II Biomet, Inc.
Jun 4, 2014 ROSA Surgical Device 2.5.8 It is intended to be used in the operating ro... Software corrections reactivating the cooperative endoscopy mode. Class II Zimmer Biomet, Inc.
May 15, 2014 DISCOVERY ELBOW prosthesis, 4 MM X 100 MM RIGHT HUMERAL FLANGED I BOND COAT T... Surface finish is different than specified. The implant has 30 grit blast on the exterior of the... Class II Biomet, Inc.
May 15, 2014 Biomet Spine, Cypher MIS Screw Inserter, Catalog number 14-501669, instrumen... The Cypher MIS Screw Inserter may exhibit an increased rate of instrument tip failure. Class II Ebi, Llc
May 7, 2014 G7 Acetabular System Positioning Guide Rod, orthopedic surgical instrument fo... Guide rod may fracture during impaction of the acetabular shell and be retained in the inserter o... Class II Biomet, Inc.
May 7, 2014 G7 Acetabular System Positioning Guide Post, orthopedic surgical instrument f... Guide rod may fracture during impaction of the acetabular shell and be retained in the inserter o... Class II Biomet, Inc.
Apr 22, 2014 ExploR 7x26mm Modular Radial Stem, Catalog number 11-210062. Elbow prosthesi... This lot of the ExploR Modular Radial Stem may be missing the wedge ramp threads. If the wedge r... Class II Biomet, Inc.
Apr 15, 2014 EZPass Suture Retriever, Nitinol, Single Pack, Part number 10007380. Orthope... The nitinol wire or monofilament may buckle within the EZPass Suture Passer and become kinked mak... Class II Biomet, Inc.
Apr 15, 2014 EZPass Passer, Sterile single use arthroscopic instrument utilized in conjunc... The nitinol wire or monofilament may buckle within the EZPass Suture Passer and become kinked mak... Class II Biomet, Inc.
Apr 15, 2014 EZPass Nylon Monofilament Single Pack, Part number 110007379, Orthopedic Manu... The nitinol wire or monofilament may buckle within the EZPass Suture Passer and become kinked mak... Class II Biomet, Inc.
Feb 26, 2014 Part 475625, Intramedullary Bone Saw, Cam Assembly Size 13 mm, The Biom... Incorrect labeling on specific lots of the Intramedullary Bone Saw. The Saw Blade Assembly was id... Class II Biomet, Inc.
Feb 26, 2014 Part 475620 Intramedullary Bone Saw CAM Assembly Size 12mm, A unique an... Incorrect labeling on specific lots of the Intramedullary Bone Saw.The Saw Blade Assembly was ide... Class II Biomet, Inc.
Feb 26, 2014 Part 475630, Intramedullary Bone Saw, Cam Assembly Size 14 mm, The Bi... Incorrect labeling on specific lots of the Intramedullary Bone Saw. The Saw Blade Assembly was id... Class II Biomet, Inc.
Feb 14, 2014 ROSA Surgical Device 2.5.8. It is intended to be used in the operating ro... An undetected shift between the information displayed in the navigation software and the actual p... Class II Zimmer Biomet, Inc.
Dec 19, 2013 Locking Cortical Screw 3.5mmX38mm REF 8161-35-038 3.5mmx38mm Locking Cortical Screw, implants are being recalled since an investigation identified ... Class II Biomet, Inc.
Dec 18, 2013 ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled ele... Possible break in the connector of the Force Sensor. Class II Zimmer Biomet, Inc.
Nov 26, 2013 outer box: Ref 906768, CurvTek Eye Needle 22 MM X-large Stainless Steel, Sin... Inner label of PN: 906768 Lot: 055450 CurvTek Eye Needle 22mm X-Large states incorrectly PN: 906... Class II Biomet, Inc.
Nov 26, 2013 G7 Acetabular Screw 6.5mmx35mm Part Number: 010001000 Investigation identified that the outer label, inner label, and patient label all have the incorr... Class II Biomet, Inc.
Oct 25, 2013 REF 200068 Security (TM) Enclosed Carpal Tunnel System Blade ( Single) ABS /... Security Blades were manufactured oversized and potentially won't advance or may be difficult to ... Class II Biomet, Inc.
Oct 23, 2013 Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, ... The user database delivered for download contained an erroneous value. Specifically the "aO" cons... Class II Carl Zeiss Meditec, Inc.
Oct 23, 2013 Zeiss brand IOLMaster 500, Model 500, Biomicroscope, Slit-Lamp, AC-Powered, ... The user database delivered for download contained an erroneous value. Specifically the "aO" cons... Class II Carl Zeiss Meditec, Inc.
Oct 10, 2013 Juggerknotless Drill Bit, REF 110003173, Sterile, Single Use Product Usa... Investigation identified that the design of the drill bit may make the suture anchor difficult to... Class II Biomet, Inc.
Oct 3, 2013 ENDOBON XENOGRAFT GRANULES 0.5 ML (Bovine bone substitute) Endobon is a bo... Individual pieces of a batch of Biomet's Endobon Xenograft Granules 0.5 ML (Bovine Bone substitut... Class III Biomet 3i, LLC
Sep 24, 2013 Shortened Plug Driver; Low Volume Specialty Device; Qty:1; Rx Only; Non Steri... Biomet received a complaint on 5/20/2013 reporting that the tip of the instrument sheared off dur... Class II Ebi, Llc
Sep 20, 2013 Biomet Microfixation Temporomandibular Joint (TMJ) Patient Matched Left Fossa... Product mix occurred prior to final package and labeling process. Class II Biomet Microfixation, LLC
Aug 29, 2013 BIOMET 3i Endosseous Dental Implant. Due to residual machining fluid identified by discoloration (darker in appearance) on the externa... Class II Biomet 3i, LLC
Aug 26, 2013 Dental Abutment labeled in part: "4555 Riverside Drive Palm Beach Gardens, FL... Reports relating to Biomet 3i's BellaTek Zirconia Dental Abutment fractures were received. Class II Biomet 3i, LLC
Aug 22, 2013 Timberline Anchored Lateral Variable Retractable Sleeve LITPCR8600-2101-07, M... The inner diameter of the Sleeve shaft is undersized, resulting in interference fit when insertin... Class II Biomet Spine, LLC
Aug 22, 2013 Anchored Lateral Retractable Drill, Timberline IPF IFU IFU8621-0113, Model 86... The outer diameter of the Drill shaft is oversized; thereby, resulting in interference fit when i... Class II Biomet Spine, LLC
Aug 22, 2013 Timberline Anchored Lateral Fixed Retractable Sleeve Model No. 8630-0205. Ti... The inner diameter of the Sleeve shaft is undersized, resulting in interference fit when insertin... Class II Biomet Spine, LLC
Aug 22, 2013 BIOMET Spine, 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System... Polaris Translation Screw Failures were recently reported to Biomet Spine. These failures are ge... Class II Ebi, Llc
Aug 13, 2013 Cypher MIS Screw System, Biomet Spine Parsippany, NJ 07054. The Cypher MIS Sc... Several complaints were reported to exhibit screw head splay in the Cypher MIS Screw System. Class II Ebi, Llc
Aug 9, 2013 Sonogage EyeScan, A-Scan Biometer, Product Usage: A-Scan Biometer diagno... During an FDA inspection on 7/15-26/2013, it was discovered that the firm lacked registration and... Class II Sonogage Inc
Jul 22, 2013 Contra-Angle Torque Driver Kit For Certain and External Connection Product... During recent revised sterilization validation testing, the included surgical trays did not meet ... Class II Biomet 3i, LLC
Jul 22, 2013 Contra-Angle Torque Driver Kit For Certain Internal Connection Product Usa... During recent revised sterilization validation testing, the included surgical trays did not meet ... Class II Biomet 3i, LLC
Jul 22, 2013 Contra-Angle Torque Driver Kit Product Usage: Molded plastic tray used in... During recent revised sterilization validation testing, the included surgical trays did not meet ... Class II Biomet 3i, LLC
Jul 22, 2013 Navigator Surgical Kit Product Usage: Molded plastic tray used in holding... During recent revised sterilization validation testing, the included surgical trays did not meet ... Class II Biomet 3i, LLC
Jul 22, 2013 Tapered Navigator Certain Surgical Kit Product Usage: Molded plastic tray... During recent revised sterilization validation testing, the included surgical trays did not meet ... Class II Biomet 3i, LLC
Jun 10, 2013 Osseotite Parallel Walled Certain 4mm(D)X 15mm (L) Dental Implant Product ... One of the dental implants do not have the internal hex feature. One of the dental implants do n... Class II Biomet 3i, LLC
Jun 10, 2013 Osseotite 2 Certain Prevail 5mm(D)X 4.1mm (P) X X 11.5mm (L) Dental Implant ... One of the dental implants do not have the internal hex feature. One of the dental implants do n... Class II Biomet 3i, LLC
Jun 7, 2013 REF 154236 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F4... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 REF 154230 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E5... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 REF 154214 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C3... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 REF 154207 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B3... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 REF 154217 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C6... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, 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.