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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
Apr 15, 2016 Beacon Tip Royal Flush Plus High-Flow Catheter Catheter, Intravascular, Diag... Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or ... Class II Cook Inc.
Apr 15, 2016 Shuttle Select Slip-Cath Catheter, Intravascular, Diagnostic The catheters ... Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or ... Class II Cook Inc.
Apr 15, 2016 Aprima Access Nonvascular Introducer Set Accessories, Catheter Intended for... Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or ... Class II Cook Inc.
Apr 15, 2016 Neff DAgostino Percutaneous Access Set Accessories, Catheter Intended for s... Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or ... Class II Cook Inc.
Apr 11, 2016 PerFuse Decompression Instrument PN: 800-0541, Lot:100650. Designed to acces... The Trocar and Plunger Assemblies are missing from the instrument, which could result in a delay ... Class II Biomet, Inc.
Apr 8, 2016 ROSA Surgical Device 2.5.8 Potential for software to change the final tool orientation for the command position without comm... Class II Zimmer Biomet, Inc.
Apr 1, 2016 Various trauma and sports medicine instruments and implants. guide, surgical... Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... Class II Biomet, Inc.
Apr 1, 2016 Various trauma and sports medicine instruments and implants. Bit, drill. Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... Class II Biomet, Inc.
Apr 1, 2016 Various trauma and sports medicine instruments and implants. Passer. Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... Class II Biomet, Inc.
Apr 1, 2016 Various trauma and sports medicine instruments and implants. Pin, fixation, ... Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... Class II Biomet, Inc.
Apr 1, 2016 Various trauma and sports medicine instruments and implants. Appliance, fixa... Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... Class II Biomet, Inc.
Apr 1, 2016 Various trauma and sports medicine instruments and implants. Fastener, fixat... Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... Class II Biomet, Inc.
Apr 1, 2016 Various trauma and sports medicine instruments and implants. Plate, fixation... Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... Class II Biomet, Inc.
Apr 1, 2016 Various trauma and sports medicine instruments and implants. Reamer. Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... Class II Biomet, Inc.
Apr 1, 2016 Various trauma and sports medicine instruments and implants. cannula, surgic... Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... Class II Biomet, Inc.
Apr 1, 2016 Various trauma and sports medicine instruments and implants. Orthopedic manu... Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... Class II Biomet, Inc.
Apr 1, 2016 Various trauma and sports medicine instruments and implants. Arthroscope. Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... Class II Biomet, Inc.
Apr 1, 2016 Various trauma and sports medicine instruments and implants. Screw, fixation... Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... Class II Biomet, Inc.
Apr 1, 2016 Various trauma and sports medicine instruments and implants. Spinal interlam... Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... Class II Biomet, Inc.
Apr 1, 2016 Various trauma and sports medicine instruments and implants. Rod, fixation, ... Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... Class II Biomet, Inc.
Mar 15, 2016 PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on Cardio... This lot of test strips is showing an under-recovery when tested against a reference method. Class II Polymer Technology Systems, Inc.
Mar 9, 2016 All instrumentation associated with the Prelude PF Resurfacing Knee System. Inadequate design control. Class II Biomet, Inc.
Mar 8, 2016 Liko Universal SlingBars Universal SlingBar" 350, Universal SlingBar" 35... The center bolt of the sling bar, which connects the bar to the patient lift, has failed during u... Class II Hill-Rom, Inc.
Mar 7, 2016 Estradiol III; Elecsys and cobas e analyzers; REF 06656021 190; M 6.5 mL, R1 ... Due to the risk of a recently identified cross reactivity, the Elecsys Estradiol assay should not... Class II Roche Diagnostics Operations, Inc.
Mar 7, 2016 Estradiol II Elecsys and cobas e analyzers REF 03000079 190; M 6.5mL, R1 8 ... Due to the risk of a recently identified cross reactivity, the Elecsys Estradiol assay should not... Class II Roche Diagnostics Operations, Inc.
Feb 26, 2016 Tina-Quant (Latex) HS Test System (C-Reactive Protein (Latex) High Sensitive... Tina-quant Cardiac C-reactive Protein (Latex) High Sensitive (CRPHS) lot number 604450 (catalog n... Class II Roche Diagnostics Operations, Inc.
Feb 23, 2016 cobas p 512 pre-analytical system Pre-analytical sample handling that incl... Due to a false triggering or detection of the lifting gripper READY signal, sample tubes are not ... Class II Roche Diagnostics Operations, Inc.
Feb 16, 2016 Verso Shoulder Forked Retractor (Comprehensive Instrumentation 2 Prong Retrac... Zimmer Biomet Inc. Verso Shoulder Forked Retractor (Comprehensive Instrumentation 2 Prong Retract... Class II Biomet, Inc.
Feb 16, 2016 HipLOC CHS Plate/Lag Screw Introducer A complaint was received where the Hiploc Plate/Lag Screw Introducer was undersized and would not... Class II Biomet, Inc.
Feb 11, 2016 Accu-Chek Inform II Base Unit as a part of the Accu-Chek Inform II Blood Gluc... Accu-Chek Inform II Base Unit might produce physical transmission errors in the form of data loss... Class II Roche Diagnostics Operations, Inc.
Feb 11, 2016 M/L Taper Hip Prosthesis (Item: 00-7711-012-20, Lot: 62937093 Zimmer Biomet initiated a lot-specific voluntary recall on 02/11/2016, of the M/L Taper Hip Prost... Class II Zimmer Biomet, Inc.
Feb 5, 2016 Vanguard XP Knee System Porous Femoral Component various sizes and orientat... The anterior/posterior (AP) dimension may be oversized by 0.016. If the femoral component does... Class II Biomet, Inc.
Jan 29, 2016 Crosslock DVR ePAK -Sterile, Ref 81180050, are complete surgical sets includi... Components of the DVR ePAKs can oxidize during shipment and storage prior to use. A delay in sur... Class II Biomet, Inc.
Jan 27, 2016 UltraxxTM Nephrostomy Balloon Set The Ultraxx" Nephrostomy Balloon Set consi... Cook Medical is voluntarily recalling specific lots of the Ultraxx" Nephrostomy Balloon Set and t... Class II Cook Inc.
Jan 27, 2016 Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set The Ascend¿ AQ¿ Ureteral ... Cook Medical is voluntarily recalling specific lots of the Ultraxx" Nephrostomy Balloon Set and t... Class II Cook Inc.
Jan 20, 2016 Hill-Rom Bariatric Power Recliner, Product Model # P9096 Hill-Roms 660 lb P... The recliners were shipped without the foot rest ottoman linkage side shields, which could result... Class II Hill-Rom, Inc.
Jan 20, 2016 Herga foot switch, model 6289-WS, a component of the ROSA Robotized Stereotac... Complaints were received reporting the system would freeze/shut down while in Fulgurate mode. Class II Zimmer Biomet, Inc.
Jan 20, 2016 Flexor Check-Flo Introducer, Catheter introducer, Catalog #: KCFW-6.0-35-70... Incorrect packaging. Reports of packages labeled as 6.0Fr actually containing 5.0Fr devices. Class II Cook Inc.
Jan 11, 2016 Gender PFJ FEMORAL COMP, prosthesis, knee, patello/femorotibial, semi-const... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 ZIMMER UNI HIGH FLEX PRECOAT FEM prosthesis, knee, femorotibial, non-constr... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 NexGen Knee LPS Porous FEM NexGen Knee LPS Option FEM NexGen Knee Lock FEM ... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 LPS-FLEX GSF OPT prosthesis, knee, patellofemorotibial, semi-constrained, c... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 CR Flex GSF Porous Femoral LPS Flex GSF Porous Femoral LPS Flex Porous Femo... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 PRCT MIS CR MOB PLT prosthesis, knee, patellofemorotibial, semi-constrained,... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 VERSYS 6 INCH BEADED FC 1 prosthesis, hip, semi-constrained, metal/polymer, ... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 Bipolar Shell prosthesis, hip, semi-constrained, metal/ceramic/polymer, ceme... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 NKII CSTI Porous Femoral NKII NP Femoral prosthesis, knee, patellofemorotib... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 CPT 12/14 COCR prosthesis, hip, semi-constrained, metal/polymer, porous unce... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 Metasul Head 40, 12/14, SZ M/0 total hip prosthesis - metal femoral heads N... LDPE bag containing the implant adheres to the highly polished implant surface. Class II Zimmer Biomet, Inc.
Jan 11, 2016 VERSYS 7.5 INCH BEADED FC prosthesis, hip, semi-constrained, metal/polymer, ... LDPE bag containing the implant adheres to the highly polished implant surface. 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.