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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

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
Feb 28, 2017 Segmental fluted stem, 19x190mm str, Sterile, Knee joint femorotibial meta/... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Segmental fluted stem, 18x190mm str, Sterile, Knee joint femorotibial meta/... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Xl por st 24.0x220mm, bowed, Sterile, Rod, fixation, intramedullary and acc... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Segmental malefemale taper, 220mm, Sterile, Knee joint femorotibial meta/po... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Fem IM Nail 16mmdx38cm, Sterile, Rod, fixation, intramedullary and accessor... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Fem IM Nail 14mmdx48cm left, Sterile, Rod, fixation, intramedullary and acc... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Segmental fluted stem, 17x190mm str, Sterile, Knee joint femorotibial meta/... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Por fullct fem st 17x200mm, Sterile, Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 27, 2017 MEDTECH ROSA Brain 3.0 The device is intended for the spatial positioning an... Unapproved change made by the supplier. Class II Zimmer Biomet, Inc.
Feb 27, 2017 MEDTECH ROSA Spine 1.0.2 The device is intended for the spatial positioning ... Unapproved change made by the supplier. Class II Zimmer Biomet, Inc.
Feb 23, 2017 TotalCare Bed Systems, Model Numbers P1900, PR1900, and U1900 with 3-Level Pa... The bed exit alarm may not function properly if the alarm has been armed for a period longer than... Class II Hill-Rom, Inc.
Feb 17, 2017 various polyethylene implants Custom parts Product Usage: Custom Endotoxin levels higher than process maximum limits were discovered in the identified polyethylen... Class II Zimmer Biomet, Inc.
Feb 17, 2017 various polyethylene implants Extremities, Shoulders and Elbows BioModular... Endotoxin levels higher than process maximum limits were discovered in the identified polyethylen... Class II Zimmer Biomet, Inc.
Feb 17, 2017 various polyethylene implants Hips Active Articulation ArComXL Bearings A... Endotoxin levels higher than process maximum limits were discovered in the identified polyethylen... Class II Zimmer Biomet, Inc.
Feb 17, 2017 various polyethylene implants BIO PLUG 10MM Product Usage: Non-weig... Endotoxin levels higher than process maximum limits were discovered in the identified polyethylen... Class II Zimmer Biomet, Inc.
Feb 17, 2017 various polyethylene implants Knees Revision Tibial Tray Systems Oxford P... Endotoxin levels higher than process maximum limits were discovered in the identified polyethylen... Class II Zimmer Biomet, Inc.
Feb 17, 2017 various polyethylene implants Sports Med Repicci II Tibial Components P... Endotoxin levels higher than process maximum limits were discovered in the identified polyethylen... Class II Zimmer Biomet, Inc.
Feb 14, 2017 Orthosize Templating Version 1.2.6 Echo Bi-Metric Hip Stem Digital Templates... Digital templates were created with the incorrect files. Class II Zimmer Biomet, Inc.
Feb 1, 2017 Flexor Radial Access Set, Individual product is packaged in a Tyvek-film ster... Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene val... Class II Cook Inc.
Feb 1, 2017 Check-Flo Introducer Hausdorf-Lock Atrial, Individual product is packaged in ... Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene v... Class II Cook Inc.
Feb 1, 2017 Check-Flo Performer Introducer Set, Individual product is packaged in a Tyvek... Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene v... Class II Cook Inc.
Feb 1, 2017 Check-Flo Performer Introducer, Individual product is packaged in a Tyvek-fil... Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene v... Class II Cook Inc.
Feb 1, 2017 Check-Flo Hemostasis Assembly, Individual product is packaged in a Tyvek-film... Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene v... Class II Cook Inc.
Feb 1, 2017 TriForce Peripheral Crossing Set, Individual product is packaged in a Tyvek-f... Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene v... Class II Cook Inc.
Feb 1, 2017 Micropuncture Check-Flo Performer Introducer Set, Individual product is packa... Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene v... Class II Cook Inc.
Jan 10, 2017 1.5mm System, Cranio-maxillofacial Bone Screws 1.5 x 4mm HT SD X-DR Screw, B... The identification of the devices was non-conforming with off-centered slots and the no-go gage s... Class II Zimmer Biomet, Inc.
Jan 6, 2017 DePuy Synthes various orthopedic instruments modified by U.S. Distributors ... Products were made outside of Quality System Regulation, and potentially outside of premarket sub... Class II DePuy Orthopaedics, Inc.
Jan 4, 2017 Vanguard Total Knee System Vanguard Open Box Femoral Components Item Numb... packaging of some femoral components was incorrectly labeled as either smaller or larger and/or a... Class II Zimmer Biomet, Inc.
Dec 27, 2016 cobas p 612 pre-analytical system; Pre-analytical sample handling that inc... Class II Roche Diagnostics Corporation
Dec 20, 2016 Accu-Chek Connect Diabetes Management App iOS and Android: Under certain conditions the affected app versions may disregard historical bolu... Class II Roche Diabetes Care, Inc.
Dec 20, 2016 Comprehensive Reverse Shoulder System Humeral Tray Model 115340 Higher than anticipated rate of fracturing due to design. Risk of revision surgery due to fractu... Class I Zimmer Biomet, Inc.
Dec 19, 2016 Active Articulation ArComXL Polyethylene Bearings Active Articulation ArComX... Product complaints indicated that the part and lot numbers on the packaging differed from the phy... Class II Zimmer Biomet, Inc.
Dec 19, 2016 RingLoc ArComXL Highly Crosslinked Polyethylene Liners ArComXL High Wall +3m... Product complaints indicated that the part and lot numbers on the packaging differed from the phy... Class II Zimmer Biomet, Inc.
Dec 16, 2016 Orthopedic Salvage System (OSS) 9cm prosthesis, knee, femorotibial, constrai... labeling for specific lots of the Standard OSS Modular Proximal Tibia incorrectly identifies the ... Class II Zimmer Biomet, Inc.
Dec 15, 2016 Vanguard Total Knee, PUNCH THRU TRL PLATES, 63 MM Item No: 32-487261, 67 MM I... Zimmer Biomet is conducting a medical device recall for ARCOS & TPRLC broaches and rasps due to p... Class II Zimmer Biomet, Inc.
Dec 6, 2016 Oxford Fixed Lateral Bearing Size F Right, Part Number 154375 Lot 744260, Ste... Zimmer Biomet is initiating a removal of a single lot of Oxford Fixed Lateral Bearings due to mis... Class II Zimmer Biomet, Inc.
Dec 2, 2016 Walgreens At-Home A1C Test Kit, Software Version Revision D, REF Number 3056 A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% o... Class II Polymer Technology Systems
Dec 2, 2016 ReliOn FastA1C Test, Software Version Revision D, REF Number 3055 A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% o... Class II Polymer Technology Systems
Dec 2, 2016 A1CNow+ Systems (professional use product), Software Version Revision D, REF ... A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% o... Class II Polymer Technology Systems
Dec 2, 2016 CVS Health At Home A1C Test Kit, Software Version Revision D, REF Number 3059 A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% o... Class II Polymer Technology Systems
Dec 2, 2016 A1CNow SELF CHECK (European), Software Version Revision D, REF Numbers 3054, ... A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% o... Class II Polymer Technology Systems
Nov 28, 2016 Cook Spectrum Minocycline/Rifampin Impregnated Double Lumen Central Venous Ca... Cook Medical has received reports of the trays containing the incorrect needle, which in some cas... Class II Cook Inc.
Nov 18, 2016 OrthoPediatrics PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical... Labeled as a 48mm Cortical Screw but measuring at 50mm Class III OrthoPediatrics Corp
Nov 8, 2016 LCS Complete Knee Revision System VVC Insert Product Usage: LCS VVC Inser... DePuy Orthopaedics, Inc. is voluntarily recalling one lot of the LCS Complete Knee Revision Syste... Class II DePuy Orthopaedics, Inc.
Oct 31, 2016 MSS CASSETTE GLU/LAC/UREA (BUN) as a part of the Roche OMNI S Analyzer: coba... Incorrect Urea results may be generated sporadically on cobas b 221<6>Roche OMNI S6 system and ca... Class II Roche Diagnostics Operations, Inc.
Oct 25, 2016 ACTIS Flex Reamers SZ 0/1; 2/3; 4/5; 6/7; 8/9; 10/11; 12, Product is sold non... DePuy Orthopaedics, Inc. is issuing a voluntary recall for all lots of the ACTIS Flex Reamers due... Class II Depuy Orthopaedics Inc.
Oct 11, 2016 ROSA Brain, 3.0.0 The device is intended for the spatial positioning and ori... Complaint of the head holder connector locking up mechanically when tightened. Class II Zimmer Biomet, Inc.
Oct 4, 2016 Tina-Quant Hemoglobin A1c Gen. 2 Hemoglobin A1c test Catalog number 0452812... Roche Diagnostics has confirmed elevated QC and patient sample recovery for individual Tina-quan... Class II Roche Diagnostics Operations, Inc.
Oct 4, 2016 COBAS INTEGRA 800 Tina-Quant Hemoglobin A1cDX Gen.2 Hemoglobin A1cDX test Ca... .Roche Diagnostics has confirmed elevated QC and patient sample recovery for individual Tina-qua... Class II Roche Diagnostics Operations, Inc.
Sep 28, 2016 Zimmer¿ Gender Solutions" Patellofemoral Joint Prosthesis Milling Handpiece Complaints have been reported that the handpiece is inoperable. The investigation found that the ... Class II Zimmer 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.