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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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Browse Device Recalls

2,549 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,549 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 2,549 FDA device recalls in IN.

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DateProductReasonClassFirm
Apr 1, 2014 TRABECULAR METAL MODULAR ACETABULAR SYSTEM, Shell with Cluster Holes, Porous... The shell was missing the locking ring. Class II Zimmer, Inc.
Mar 28, 2014 GLOBAL¿ Anchor Peg Glenoid Plus (APG+) 2.5MM Breakaway Guide Pin Part # 223... Urgent Device Correction notifications are being sent to USA distributors with follow-up to surge... Class II DePuy Orthopaedics, Inc.
Mar 19, 2014 DROP LOK" Knee Brace***LATEX FREE" Product Usage: Used in the treatment,... During a transfer of products from a recently shutdown facility, the firm discovered raw material... Class II Zimmer, Inc.
Mar 19, 2014 Cartilage Knee Brace***LATEX FREE" Product Usage: Used in the treatmen... During a transfer of products from a recently shutdown facility, the firm discovered raw material... Class II Zimmer, Inc.
Mar 19, 2014 Hinged Knee Support***LATEX FREE" Product Usage: Provide added lateral st... During a transfer of products from a recently shutdown facility, the firm discovered raw material... Class II Zimmer, Inc.
Mar 19, 2014 Tennis Elbow Support, Neoprene***LATEX FREE" Product Usage: Provides com... During a transfer of products from a recently shutdown facility, the firm discovered raw material... Class II Zimmer, Inc.
Mar 13, 2014 Cobas c8000 Modular Analyzer Series Cobas c502, Part Number 5964067001, a c... The Initial Cassette Volume Check (ICVC) is not activated on the cobas c 502 module of the cobas ... Class II Roche Diagnostics Operations, Inc.
Feb 28, 2014 Omni Micro-electrode/reference electrode for cobas b221 analyzer, Model/Cata... Reference electrode used beyond the guaranteed in-use 52 week lifetime,may leak and potentially ... Class II Roche Diagnostics Operations, 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 25, 2014 Apollo" Knee System: APOLLO PATELLA SZ0 28MM R A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... Class II Zimmer, Inc.
Feb 25, 2014 Apollo" Knee System: PS TIB INS SZ0/16MM APOLL PS TIB INS SZ0/19MM APOLL P... A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... Class II Zimmer, Inc.
Feb 25, 2014 Natural-Knee¿ II System: POLY ULTRA TIB LT SZ00/9M POLY ULTRA TIB LT SZ0/9M... A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... Class II Zimmer, Inc.
Feb 25, 2014 Apollo" Revision/Constrained Knee System: SZ0-16MM AK CCK TIB INSER SZ1-11M... A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... Class II Zimmer, Inc.
Feb 25, 2014 Natural-Knee¿ II System ULTRA CONG INS LT SZA/9MM ULTRA CONG INS LT SZA/13M... A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... Class II Zimmer, Inc.
Feb 25, 2014 Gender Solutions" Natural-Knee¿ Flex System: N-K FLEX MBACK SZ 0 PAT N-K FL... A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... Class II Zimmer, Inc.
Feb 25, 2014 Natural-Knee¿ II Constrained Knee System NKII CCK TIB INS SZ00/0-L NKII CCK... A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... Class II Zimmer, Inc.
Feb 25, 2014 Natural-Knee¿ II Unicompartmental Knee System: UNI ALL-POLY TIB SZ 1-7mm UN... A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... Class II Zimmer, Inc.
Feb 25, 2014 Natural-Knee¿ Congruent Tibial Insert with Screw: SF-CON TIB INS LT SZ1/2 1 ... A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... Class II Zimmer, Inc.
Feb 25, 2014 MOST Options" System (MOST) HINGED TIB INS SZ 1 16MM HINGED TIB INS SZ 4 6M... A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... Class II Zimmer, Inc.
Feb 25, 2014 Natural-Knee¿ N-K II DOMED ALL-POLY PAT, SZ0 N-K II DOMED ALL-POLY PAT, SZ1 A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... Class II Zimmer, Inc.
Feb 25, 2014 Apollo Knee Tibial Baseplate/Knee Tibial Insert: CONG TIB INS SZ0/19MM APO ... A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... Class II Zimmer, Inc.
Feb 25, 2014 Natural-Knee¿ II - Unicompartmental Knee Prosthesis: CONG TIB INS SZ1/2 9MM ... A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... Class II Zimmer, Inc.
Feb 25, 2014 Natural-Knee¿ II Posterior Stabilized (P.S.) Condylar Tibial Inserts: N-K II... A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... Class II Zimmer, Inc.
Feb 25, 2014 Natural-Knee¿/Apollo" Knee: M/B PAT SZ0 NATURAL-KNEE M/B PAT SZ1 NATURAL-KN... A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... Class II Zimmer, Inc.
Feb 24, 2014 REF 623421 RS-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (wit... DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexi... Class II DePuy Orthopaedics, Inc.
Feb 24, 2014 Myriad handpiece Tissue morcellator This recall has been initiated due to a defective component within the handpiece which will caus... Class II Nico Corp.
Feb 24, 2014 REF 623421 L S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (wi... DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexi... Class II DePuy Orthopaedics, Inc.
Feb 24, 2014 REF 623401 L S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (w... DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexi... Class II DePuy Orthopaedics, Inc.
Feb 24, 2014 REF 623411 L, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (w... DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexi... Class II DePuy Orthopaedics, Inc.
Feb 24, 2014 REF 623401 R, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (w... DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexi... Class II DePuy Orthopaedics, Inc.
Feb 24, 2014 REF 623411 R S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (wi... DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexi... Class II DePuy Orthopaedics, 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.
Feb 10, 2014 BencoDental tartar & stain remover ultrasonic cleaning solution Product Us... As the result of a complaint to Heraeus Kulzer's customer service department, Heraues Kulzer is r... Class II Heraeus Kulzer, LLC.
Jan 10, 2014 00434811113, REF I4348-111-13 Zimmer Trabecular Metal Shoulder Humeral St... This single manufacturing lot has the potential for the bond strength between the Trabecular Meta... Class II Zimmer, Inc.
Jan 8, 2014 3.5mm Locking Cortical Bone Screw, T15 Hexalobe, Self Tapping, 20mm Part No.... OrthoPediatrics has initiated a Voluntary RECALL of Part # 00-0903-2620, 3.5MM Locking Cortical ... Class II OrthoPediatrics Corp
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 19, 2013 Zimmer Segmental Systems; Polyethylene Inserts, Size C. Knee replacement. After evaluation of 13 complaints(0.4% rate) for hyper-extension of the Zimmer Segmental System, ... Class II Zimmer, Inc.
Dec 19, 2013 Zimmer Segmental Systems; Polyethylene Inserts, Size B. Designed to addres... After evaluation of 13 complaints(0.4% rate) for hyper-extension of the Zimmer Segmental System, ... Class II Zimmer, 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.
Dec 13, 2013 King Systems KLTSD414 Quantity, 5 PER CASE KING LTSD KIT SIZE 4 King... KLTD214 airways found inside KLTSD414 packages. The KLTSD414 airway has a lumen for use of a gas... Class II King Systems Corp.
Dec 12, 2013 King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is inten... On December 13, 2012, King Systems initiated a voluntary recall of one (1) case(s) (5) individual... Class II King Systems Corp.
Dec 10, 2013 Trabecular Metal (TM) Reverse Glenosphere 36mm Part 00-4349-036-11 The r... Zimmer is initiating a lot specific recall of the CPT Hip Stem, Versys Build-Up Block, and Trabec... Class II Zimmer, Inc.
Dec 10, 2013 CPT Hip System, Parts 00-8114-002-10 and 00-8011-004-00 Hip joint metal/poly... Zimmer is initiating a lot specific recall of the CPT Hip Stem, Versys Build-Up Block, and Trabec... Class II Zimmer, Inc.
Dec 10, 2013 Versys Build-Up Block The VerSys CRC Hip System is indicated for total hip... Zimmer is initiating a lot specific recall of the CPT Hip Stem, Versys Build-Up Block, and Trabec... Class II Zimmer, Inc.
Dec 9, 2013 PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devices; (Size 5/RT) U... Knee implant femoral devices were found to have anomalous microstructure. Porosity and the presen... Class II DePuy Orthopaedics, 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.
Nov 25, 2013 MagNA Pure 96 System Version 1.0 Software Version 2.0 Robotic workstatio... This issue is only relevant for customers importing xml files into the MagNA Pure 96 IVD instrume... Class II Roche Diagnostics Operations, 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.