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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

3,313 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,313 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 3,313 FDA device recalls in 2017.

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DateProductReasonClassFirm
May 9, 2017 Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter... Arrow International is recalling the affected product because the packaging may not be completely... Class II Arrow International Inc
May 9, 2017 Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+a... Arrow International is recalling the affected product because the packaging may not be completely... Class II Arrow International Inc
May 9, 2017 Access System-GI Monitor (CA19-9), A83873D, Catalog No. 387687 The Access immunoassays are susceptible to biotin interference. Class II Beckman Coulter Inc.
May 9, 2017 1) Pressure Injectable Multi-Lumen Central Venous Catheterization Kit 2) Pre... Arrow International is recalling the affected product because the packaging may not be completely... Class II Arrow International Inc
May 9, 2017 1) Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The ... Arrow International is recalling the affected product because the packaging may not be completely... Class II Arrow International Inc
May 9, 2017 Arterial Catheterization Kit, Arterial Line Kit with Sharps Safety Features... Arrow International is recalling the affected product because the packaging may not be completely... Class II Arrow International Inc
May 9, 2017 1) Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Fea... Arrow International is recalling the affected product because the packaging may not be completely... Class II Arrow International Inc
May 9, 2017 Hudson RCI, Pediatric Nasal Cannula, Non-Flared Prongs, Rx only, Incorrect labeling; the box label indicates Pediatric, the product insert indicates an Adult ... Class II Teleflex Medical
May 9, 2017 Arrow Pressure Injectable PICC Kit Catheter, Intravascular, Therapeutic, Lon... The Arrow Pressure Injectable PICC is intended for short-term or long-term peripheral access to t... Class II Arrow International Inc
May 8, 2017 Merge PACS software. The firm name on the label is Merge Healthcare, Hartlan... Merge PACS did not show unviewed images when the last view was skipped. There is a potential risk... Class II Merge Healthcare, Inc.
May 8, 2017 Reusable instruments in the Knee, Hip, Trauma, and Extremities segments. Durability characteristics of reusable instruments were not established Class II Zimmer Biomet, Inc.
May 8, 2017 MiniMed 640G Insulin Infusion Pump, Catalog No. MMT-1511, MMT-1711, MMT-1512,... Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporar... Class II Medtronic Inc.
May 8, 2017 MiniMed 630G Insulin Infusion Pump, Catalog No. MMT-1715, MMT-1755. Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporar... Class II Medtronic Inc.
May 8, 2017 MiniMed 670G Insulin Infusion Pump, Catalog No. MMT-1580, MMT-1780, MMT-1782,... Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporar... Class II Medtronic Inc.
May 8, 2017 MiniMed 620G Insulin Infusion Pump, Catalog No. MMT-1510, MMT-1710, MMT-1550,... Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporar... Class II Medtronic Inc.
May 8, 2017 Beekley Medical 0-SPOT Mammography Skin Markers REF 652 Mammography Skin Marker 0 -SPOT (REF 652) product was mis-labeled with A-SPOT (REF 651) labels Class III Beekley Corporation
May 8, 2017 Electrophysiology catheter cables are designed as electrode cables with a mu... Sterilmed is recalling all lots of specific product codes of unexpired Sterilmed Reprocessed EP A... Class II Sterilmed Inc
May 8, 2017 Merge PACS software. Merge PACS (Picture Archiving Communication System) is... When cut lines are shown on an image, the lines may go from being vertical and then shift to hori... Class II Merge Healthcare, Inc.
May 5, 2017 Her2/Neu (c-erbB-2) (CB-1 1); 7.0 mL Catalog number 237M-18. In vitro diagn... Cell Marque has determined the need to issue a product recall after identifying product intended ... Class II Cell Marque Corporation
May 5, 2017 Estrogen Receptor (EP1) 7.0 mL Catalog number 249R-28; 1.0 mL Catalog num... Cell Marque has determined the need to issue a product recall after identifying product intended ... Class II Cell Marque Corporation
May 5, 2017 SV40 (MRQ-4) 0.5 ml catalog number 351 M-15. Microbiology - Analyte Spec... Cell Marque has determined the need to issue a product recall after identifying product intended ... Class II Cell Marque Corporation
May 5, 2017 Estrogen Receptor (SP1) 7.0 mL Catalog number 249R-18; Hematology - Anal... Cell Marque has determined the need to issue a product recall after identifying product intended ... Class II Cell Marque Corporation
May 5, 2017 Arsenal Spinal Fixation System, Set Screw, Part No. 47027 Product Usage:... Alphatec Spine is recalling the Arsenal Spinal Fixation System Set Screw due to a trend in set sc... Class II Alphatec Spine, Inc.
May 5, 2017 CD117, c-kit (YR145) 1.0 ml catalog number 117R-16 7.0 ml catalog number-18... Cell Marque has determined the need to issue a product recall after identifying product intended ... Class II Cell Marque Corporation
May 5, 2017 Adenovirus (20/11 & 2/6); 0.5 mL Catalog # 212M-15; and 7.0 mL Catalog nu... Cell Marque has determined the need to issue a product recall after identifying product intended ... Class II Cell Marque Corporation
May 5, 2017 Herpes Simplex Virus II 0.5 ml catalog number 362A-15 7.0 mL Catalog number... Cell Marque has determined the need to issue a product recall after identifying product intended ... Class II Cell Marque Corporation
May 5, 2017 Her2/Neu (EP3); 0.5 mL Catalog number 237R-25; 1.0 mL Catalog number 237R-2... Cell Marque has determined the need to issue a product recall after identifying product intended ... Class II Cell Marque Corporation
May 5, 2017 Opteryx Variable Rescue Screw, Part #CP2214, UDI: *+M711CP22140/$$801716012*.... Opteryx Variable Rescue Screws are engraved with incorrect (larger) size (16 instead of 14). Class II Innovasis, Inc
May 5, 2017 Herpes Simplex Virus I; 7.0 mL Catalog number 361A-18. Microbiology - Ana... Cell Marque has determined the need to issue a product recall after identifying product intended ... Class II Cell Marque Corporation
May 5, 2017 Varicella Zoster Virus 7.0 ml catalog number 364M-18 Microbiology - Analy... Cell Marque has determined the need to issue a product recall after identifying product intended ... Class II Cell Marque Corporation
May 5, 2017 H. pylori (polyclonal} 1.0 mL Catalog number 215A-76; Hematology - Analyt... Cell Marque has determined the need to issue a product recall after identifying product intended ... Class II Cell Marque Corporation
May 5, 2017 Infant Warmer System (IWS) GE Healthcare has recently become aware of a potential safety issue related to loose screws in t... Class II GE Healthcare, LLC
May 5, 2017 HHV-8 (13810); 1.0 ml catalog number 265M-16; 7.0 ml catalog number-265M-18... Cell Marque has determined the need to issue a product recall after identifying product intended ... Class II Cell Marque Corporation
May 4, 2017 Kii Shielded Bladed trocars (CTB14), Kii Low profile trocars (CTB23), and K... Due to possibility of insufficient sterilization. Class II Applied Medical Resources Corp
May 4, 2017 NMT Patient Cable (989803174581) in use with lntelliVue NMT Module (Part# 865... Manufacturing defect may cause localized heating, which may result in localized skin burn. Class II Philips Electronics North America Corporation
May 3, 2017 Vue Optic Visualization Source, Flexor Vue Deflecting Endoscopic System, Endo... Cook Inc. is initiating a voluntary recall of the Vue Optic Visualization Source and the Flexor V... Class II Cook Inc.
May 3, 2017 Sutures. POLYSORB: POLSORB 0 18 U/D PRECUT 126R, Item Number: L4; POLSORB 0 ... Potential for an incomplete seal on the inner package, which may result in premature degradation ... Class II Medtronic
May 3, 2017 Sutures. MAXON: MAXON 4/0 5X18" GREEN CV-24 D-TACH; Item Number: 8886621933;... Potential for an incomplete seal on the inner package, which may result in premature degradation ... Class II Medtronic
May 3, 2017 USPACK-SUTURE KIT; Item Number: US1672 Potential for an incomplete seal on the inner package, which may result in premature degradation ... Class II Medtronic
May 3, 2017 Best Practice Kit, Item Numbers: 00Z2064, 00Z2150, 00Z2190, 00Z2192, 00Z2211,... Potential for an incomplete seal on the inner package, which may result in premature degradation ... Class II Medtronic
May 3, 2017 Sutures. ENDO STITCH: ENDO STITCH POLYSORB 0 48" U/D DLU SU, Item Number: 17... Potential for an incomplete seal on the inner package, which may result in premature degradation ... Class II Medtronic
May 3, 2017 Sutures. BIOSYN: BIOSYN 4/0 18" VIOLET CV-25 DT, Item Number: GMJ34M Potential for an incomplete seal on the inner package, which may result in premature degradation ... Class II Medtronic
May 3, 2017 OptiLite Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxid... Cook Inc. is initiating a voluntary recall of the OptiLite Multi-Use Holmium Laser Fibers because... Class II Cook Inc.
May 3, 2017 CUSTOM SUTURE PACK; Item Number: US1540 and US1614 Potential for an incomplete seal on the inner package, which may result in premature degradation ... Class II Medtronic
May 3, 2017 SCHRITTMACHER ANGIO X3; Item Number: 4045255423347 Potential for an incomplete seal on the inner package, which may result in premature degradation ... Class II Medtronic
May 2, 2017 Arietta 70 Ultrasound System Intended for use by trained personnel (doctor... The strength of the arm mounting mechanism was insufficient and had to be redesigned. Class II Hitachi Medical Systems America Inc
May 2, 2017 Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD Implant Direct Sybron Manufacturing is recalling the Legacy Full-Contour Abutment 3.5mmD Assembly... Class II Implant Direct Sybron Manufacturing, LLC
May 2, 2017 Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1 Carestation 620, 650 and 650c has Potential for Elevated FiCO2 and Unexpected System Malfunction Class II GE Healthcare, LLC
May 1, 2017 APLIO 300 TUS-A300 diagnostic ultrasound system When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace ... Class II Toshiba American Medical Systems Inc
May 1, 2017 APLIO i-series: a) APLIO i700 TUS AI700 b) APLIO i800 TUS AI800 diagnostic... When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace ... Class II Toshiba American Medical Systems 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.