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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

2,560 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,560 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 2,560 FDA device recalls in IN.

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DateProductReasonClassFirm
May 30, 2018 Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size ... M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior... Class II Zimmer Biomet, Inc.
May 30, 2018 Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size ... M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior... Class II Zimmer Biomet, Inc.
May 30, 2018 Zimmer¿ M/L Taper Hip Prosthesis Plasma Sprayed, Size 4 Standard Offset; 00-7... M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior... Class II Zimmer Biomet, Inc.
May 30, 2018 Zimmer¿ M/L Taper Hip Prosthesis With Kinectiv¿ Technology Cementless, Size 6... M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior... Class II Zimmer Biomet, Inc.
May 30, 2018 Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size ... M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior... Class II Zimmer Biomet, Inc.
May 24, 2018 Vanguard Complete Knee System; E1 Vanguard PS Tibial Bearing; Model Numbers E... Two lots of tibial bearings were commingled. There is a possibility that a 14mm tibial bearing is... Class II Zimmer Biomet, Inc.
May 18, 2018 Biomet Modular Primary Tibial Tray Implants; Modular Interlok Primary Tray (s... One lot of 75mm tibial tray is potentially etched and labeled as a 79 mm tibial tray. This may le... Class II Zimmer Biomet, Inc.
May 16, 2018 G-PIN 2.8BL 3.2PL 60CM 2PK; 467265 Intended to be used as a guide pin for... The firm is recalling various trauma guide wires due to insufficient packaging design verificatio... Class II Zimmer Biomet, Inc.
May 16, 2018 3.2MM X 510MM COCR THD TIP; 14-443053 Intended to be used as a guide pin ... The firm is recalling various trauma guide wires due to insufficient packaging design verificatio... Class II Zimmer Biomet, Inc.
May 16, 2018 BALL TIP GUIDE WIRE 2.0MMX60CM; 469020 Intended to be used as a guide pin... The firm is recalling various trauma guide wires due to insufficient packaging design verificatio... Class II Zimmer Biomet, Inc.
May 16, 2018 BALL TIP GUIDE WIRE 3.2MMX98CM; 469060 Intended to be used as a guide pin... The firm is recalling various trauma guide wires due to insufficient packaging design verificatio... Class II Zimmer Biomet, Inc.
May 16, 2018 DRILL PT GUIDE WIRE 3.2MMX98CM, 469360 Intended to be used as a guide pin... The firm is recalling various trauma guide wires due to insufficient packaging design verificatio... Class II Zimmer Biomet, Inc.
May 16, 2018 BEAD TIP GD WIRE 3.0MM X 60CM; 29402 Intended to be used as a guide pin ... The firm is recalling various trauma guide wires due to insufficient packaging design verificatio... Class II Zimmer Biomet, Inc.
May 16, 2018 DRILL PT GUIDE WIRE 2MM X 60CM; 469320 Intended to be used as a guide pin... The firm is recalling various trauma guide wires due to insufficient packaging design verificatio... Class II Zimmer Biomet, Inc.
May 16, 2018 GUIDE WIRE w/ BALL TIP 2.0MMX98CM; 469040 Intended to be used as a guide ... The firm is recalling various trauma guide wires due to insufficient packaging design verificatio... Class II Zimmer Biomet, Inc.
May 16, 2018 RECON DRILL 6MM X 439MM; 14-443023 Intended to be used as a guide pin for... The firm is recalling various trauma guide wires due to insufficient packaging design verificatio... Class II Zimmer Biomet, Inc.
May 16, 2018 BALL TIP GUIDE WIRE 3.2MMX55CM; 469055 Intended to be used as a guide pin... The firm is recalling various trauma guide wires due to insufficient packaging design verificatio... Class II Zimmer Biomet, Inc.
May 16, 2018 3.2MM X 560MM COCR THD TIP; 14-441053 Intended to be used as a guide pin ... The firm is recalling various trauma guide wires due to insufficient packaging design verificatio... Class II Zimmer Biomet, Inc.
May 16, 2018 G-PIN 2.8BL 3.2PL 98CM 2PK; 467260 NL DRIVING GUIDE 4.4MM X 80CM; 467220 ... The firm is recalling various trauma guide wires due to insufficient packaging design verificatio... Class II Zimmer Biomet, Inc.
May 16, 2018 G-PIN 2.8BL 3.2PL 98CM 2PK; 467260 Intended to be used as a guide pin for... The firm is recalling various trauma guide wires due to insufficient packaging design verificatio... Class II Zimmer Biomet, Inc.
May 11, 2018 Vanguard Knee System PS Tibial Bearing, Part Number 183621 Intended for u... The label master file was errantly set up as a 63/37mm instead of a 63/67mm. There is no 63/37 si... Class II Zimmer Biomet, Inc.
May 7, 2018 Accu-Chek Inform II Test Strip, Whole blood glucose test system, Catalog no. ... The recalling firm has identified two lots of test strips that are out of specification. Affected... Class II Roche Diabetes Care, Inc.
May 7, 2018 Accu-Chek Aviva Plus Test Strip, Blood glucose monitoring system, Catalog nos... The recalling firm identified four US lots of test strips out of specification. Affected strips s... Class II Roche Diabetes Care, Inc.
May 7, 2018 Accu-Chek Performa Test Strip, Blood glucose monitoring system, Catalog no. 0... The recalling firm has identified two lots of test strips that are out of specification. Affected... Class II Roche Diabetes Care, Inc.
May 1, 2018 Jasper Vektor, Class II Correction Appliance, Part No. 610-536R used for corr... The firm has received 106 complaints of the device breaking in the patient's mouth. Device breaka... Class II TP Orthodontics, Inc.
May 1, 2018 Jasper Vektor, Class II Correction Appliance, Part No. 610-527 used for corre... The firm has received 106 complaints of the device breaking in the patient's mouth. Device breaka... Class II TP Orthodontics, Inc.
May 1, 2018 Jasper Vektor, Class II Correction Appliance, Part No. 610-500 used for corre... The firm has received 106 complaints of the device breaking in the patient's mouth. Device breaka... Class II TP Orthodontics, Inc.
May 1, 2018 Jasper Vektor, Class II Correction Appliance, Part No. 610-536 used for corre... The firm has received 106 complaints of the device breaking in the patient's mouth. Device breaka... Class II TP Orthodontics, Inc.
May 1, 2018 Jasper Vektor, Class II Correction Appliance, Part No. 610-530L used for corr... The firm has received 106 complaints of the device breaking in the patient's mouth. Device breaka... Class II TP Orthodontics, Inc.
May 1, 2018 Jasper Vektor, Class II Correction Appliance, Part No. 610-533R used for corr... The firm has received 106 complaints of the device breaking in the patient's mouth. Device breaka... Class II TP Orthodontics, Inc.
May 1, 2018 Jasper Vektor, Class II Correction Appliance, Part No. 610-530R used for corr... The firm has received 106 complaints of the device breaking in the patient's mouth. Device breaka... Class II TP Orthodontics, Inc.
May 1, 2018 Jasper Vektor, Class II Correction Appliance, Part No. 610-527L used for corr... The firm has received 106 complaints of the device breaking in the patient's mouth. Device breaka... Class II TP Orthodontics, Inc.
May 1, 2018 Jasper Vektor, Class II Correction Appliance, Part No. 610-530 used for corre... The firm has received 106 complaints of the device breaking in the patient's mouth. Device breaka... Class II TP Orthodontics, Inc.
May 1, 2018 Jasper Vektor, Class II Correction Appliance, Part No. 610-533 used for corre... The firm has received 106 complaints of the device breaking in the patient's mouth. Device breaka... Class II TP Orthodontics, Inc.
May 1, 2018 Jasper Vektor, Class II Correction Appliance, Part No. 610-536L used for corr... The firm has received 106 complaints of the device breaking in the patient's mouth. Device breaka... Class II TP Orthodontics, Inc.
May 1, 2018 Jasper Vektor, Class II Correction Appliance, Part No. 610-533Lused for corre... The firm has received 106 complaints of the device breaking in the patient's mouth. Device breaka... Class II TP Orthodontics, Inc.
May 1, 2018 Jasper Vektor, Class II Correction Appliance, Part No. 610-527R used for corr... The firm has received 106 complaints of the device breaking in the patient's mouth. Device breaka... Class II TP Orthodontics, Inc.
Apr 27, 2018 Elecsys Vitamin D total II, Vitamin D Test System, Material number 0702814819... The device may give a falsely elevated result that is non-reproducible. If vitamin D level is mon... Class II Roche Diagnostics Corporation
Apr 27, 2018 Elecsys Vitamin D total II, Vitamin D Test System, Material number 0746421516... The device may give a falsely elevated result that is non-reproducible. If vitamin D level is mon... Class II Roche Diagnostics Corporation
Apr 16, 2018 Advance¿ 35LP Low-Profile PTA Balloon Dilatation Catheter; Catalog numbers: P... Incorrect product labeling. Product labeled as 6mm x 2cm balloon are packaged with a 4mm x 4 cm b... Class II Cook Inc.
Apr 16, 2018 ATTUNE Revision CRS Femoral LT SZ 5 Cemented, Catalog No. 150440105, Femoral ... There may be burrs on the extraction hole threads. Class II DePuy Orthopaedics, Inc.
Apr 16, 2018 ATTUNE Revision CRS Femoral RT SZ 5 Cemented, Catalog No. 150440205, Femoral ... There may be burrs on the extraction hole threads. Class II DePuy Orthopaedics, Inc.
Apr 5, 2018 Lactosorb RapidFlap, bone plate, Model No. 915-0020 The RapidFlap LS Crani... The recalling firm has confirmed that the Outer Plate component exhibits an excessive chamfer on ... Class II Zimmer Biomet, Inc.
Apr 3, 2018 Orthopedic Salvage System (OSS) Modular Arthrodesis 0 Degree Locking Collar, ... There is a potential dry blast irregularity on the locking collar screws packaged with the lockin... Class II Zimmer Biomet, Inc.
Apr 3, 2018 cobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is ... The syringe plunger on the device may be mounted in a tilted position, which applies mechanical s... Class II Roche Diagnostics Corporation
Apr 2, 2018 Modular Head Component, Biomet Hip System; Item No. 11-363661, Hip Joint, met... Two lots of different sized modular heads potentially commingled. Risks include delay in surgery ... Class II Zimmer Biomet, Inc.
Apr 2, 2018 Modular Head Component, Biomet Hip System; Item No. 163669, Hip Joint, metal/... Two lots of different sized modular heads potentially commingled. Risks include delay in surgery ... Class II Zimmer Biomet, Inc.
Mar 29, 2018 Connecting Tube - Female to Male Luer Lock, HPCT8.8-60-M-FM Product Usage:... Cap-adapter assembly of the device may potentially not be adequately tightened, possibly leading ... Class II Cook Inc.
Mar 29, 2018 Connecting Tube - Female to Male Luer Lock, HPCT8.8-30-M-FM Product Usage:... Cap-adapter assembly of the device may potentially not be adequately tightened, possibly leading ... Class II Cook Inc.
Mar 29, 2018 Connecting Tube - Female to Male Luer Lock, HPCT8.8-80-M-FM Product Usage:... Cap-adapter assembly of the device may potentially not be adequately tightened, possibly leading ... Class II Cook 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.