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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

3,010 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,010 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 3,010 FDA device recalls in 2019.

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DateProductReasonClassFirm
Jan 10, 2019 AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonad... hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG con... Class II PerkinElmer Life and Analytical Sciences, Walla...
Jan 10, 2019 DELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotro... hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG con... Class II PerkinElmer Life and Analytical Sciences, Walla...
Jan 10, 2019 EVOLIS Microplate System (Catalog no. 89700) with TimeLiner Data Management S... User-induced circumstances can contribute to the EVOLIS Microplate Processor System not handling ... Class II Bio-Rad Laboratories, Inc
Jan 10, 2019 21Y14 PushValve Product Usage: The PushValves/ MagValves is intended ex... Some of the installed valve-inserts have a diameter smaller than the specification. Class II Ottobock Orthopedic Industrie
Jan 10, 2019 21Y15 MagValve Product Usage: The PushValves/ MagValves is intended exclu... Some of the installed valve-inserts have a diameter smaller than the specification. Class II Ottobock Orthopedic Industrie
Jan 10, 2019 AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonad... hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG con... Class II PerkinElmer Life and Analytical Sciences, Walla...
Jan 9, 2019 SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708 Due to a complaint received and internal investigation it was determined that implant vials were ... Class II Implant Direct Sybron Manufacturing LLC
Jan 9, 2019 PageWriter TC50 Government Bundle, Product 860429, Software revisions up to a... Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing ... Class II Philips North America, LLC
Jan 9, 2019 PageWriter TC70 w/o trolley Government Bundle, Product 860353, Software revis... Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing ... Class II Philips North America, LLC
Jan 9, 2019 PageWriter TC70 w/trolley Government Bundle, Product 860352, Software revisio... Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing ... Class II Philips North America, LLC
Jan 9, 2019 Forceps Blue, disposable, sterile, 100 eaches per sales unit. Product Usag... An internal assessment of packaging confirmed the potential for a breach in the sterile barrier. Class II ConvaTec, Inc
Jan 9, 2019 PageWriter TC30 w/ trolley Government Bundle, Product 860354, Software revisi... Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing ... Class II Philips North America, LLC
Jan 9, 2019 PageWriter TC30 w/o trolley Government Bundle, Product 860355, Software revis... Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing ... Class II Philips North America, LLC
Jan 9, 2019 PageWriter TC30, Product 860306, Software revisions up to and including A.07.... Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing ... Class II Philips North America, LLC
Jan 9, 2019 PageWriter TC20, Product 860332, Software revisions up to and including A.07.... Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing ... Class II Philips North America, LLC
Jan 9, 2019 FilterFlow Suction Handle CH24, 20 eaches per sales unit. Product Usage: ... An internal assessment of packaging confirmed the potential for a breach in the sterile barrier. Class II ConvaTec, Inc
Jan 9, 2019 PageWriter TC50, Product 860310, Software revisions up to and including A.07.... Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing ... Class II Philips North America, LLC
Jan 9, 2019 PageWriter TC70, Product 860315, Software revisions up to and including A.07.... Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing ... Class II Philips North America, LLC
Jan 9, 2019 Insufflation tubing to be used with varies insufflator units. REF 031200-10; ... The sterile single-use tubing may contain higher ethylene oxide (EO) residues than the acceptable... Class III Karl Storz Endoscopy
Jan 9, 2019 NeuViz 128 Multi-slice CT Scanner System with software version 1.0.8.5010O+P... For surview scan length more than 500mm,if the user aborts or skips the reconstructed surview, th... Class II NEUSOFT MEDICAL SYSTEMS IMP & EX
Jan 9, 2019 Feeding Tube Metric, disposable, sterile, 100 eaches per sales unit. Labeled ... An internal assessment of packaging confirmed the potential for a breach in the sterile barrier. Class II ConvaTec, Inc
Jan 9, 2019 Nelaton Urinary Catheter, disposable, sterile, 100 eaches per sales unit. Lab... An internal assessment of packaging confirmed the potential for a breach in the sterile barrier. Class II ConvaTec, Inc
Jan 8, 2019 Maquet XS Flat Screen Monitor Holder, SAT XS32 12 SPE, Configuration Part Num... The affected flat screen monitor holders might not be compliant with grounding requirements. As a... Class II GETINGE US SALES LLC
Jan 8, 2019 Maquet XS Flat Screen Monitor Holder, PWD70+DF HD R XS32 K3 SPE, Configuratio... The affected flat screen monitor holders might not be compliant with grounding requirements. As a... Class II GETINGE US SALES LLC
Jan 8, 2019 Maquet XS Flat Screen Monitor Holder, PWD50+DF XS32 K3 SPE, Configuration Par... The affected flat screen monitor holders might not be compliant with grounding requirements. As a... Class II GETINGE US SALES LLC
Jan 8, 2019 Maquet XS Flat Screen Monitor Holder, XS32 SPE, Configuration Part Number ARD... The affected flat screen monitor holders might not be compliant with grounding requirements. As a... Class II GETINGE US SALES LLC
Jan 7, 2019 Pilling COOLEY SUMP-SUCTION TUBE, REF 351547 The internal tip is missing from the device, causing the device to not function as intended. Class II Teleflex Medical
Jan 7, 2019 A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z ... Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly ... Class II Acuity Surgical Devices, LLC
Jan 7, 2019 SL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613 The pin that holds the spring mechanism is not properly mounted. The pin could potentially disass... Class II Smith & Nephew, Inc.
Jan 7, 2019 A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z ... Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly ... Class II Acuity Surgical Devices, LLC
Jan 7, 2019 AVE 2 Birthing Bed LINET has recently become aware of a potential safety issue for the AVE 2 Birthing Bed caused by ... Class II Linet Spol. S.r.o.
Jan 4, 2019 Fixed Core Straight Safety Wire Guide, Guidewire, Global Product Number G14285 The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of ... Class II Cook Inc.
Jan 4, 2019 SWIN 2017 database, Model YSW4000 Potential for out of range microbial results Class II Remel Inc.
Jan 4, 2019 Sof-Flex Multi-Lenqth Ureteral Stent Set, Global Product No. G14773 G15000 ... The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of ... Class II Cook Inc.
Jan 4, 2019 Elekta Unity In rare circumstances, due to reasons such as inadequate hospital facility maintenance, water lea... Class II Elekta Limited
Jan 4, 2019 Universa Soft Ureteral Stent, Global Product No. G49887 G49933 G49934 G499... The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of ... Class II Cook Inc.
Jan 4, 2019 Percutaneous Pigtail Nephrostomy Set , Global Product No. G14094 G14095 G1... The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of ... Class II Cook Inc.
Jan 4, 2019 Acusnare Polypectomy (Duck Bill Shaped) Snare Used with an electrosurgical... Complaints of the snare loop not completely retracting and/or misshaping of the snare loop. Class II Wilson-Cook Medical Inc.
Jan 4, 2019 Percutaneous Malecot Nephrostomy Set, Global Product No. G16714 G19107 G19108 The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of ... Class II Cook Inc.
Jan 4, 2019 iTotal Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-... The labeling of the boxes and sterile pouches did not match the contents. Class II Conformis, Inc.
Jan 4, 2019 C-Flex Double Pigtail Ureteral Stent Set, Global Product No. G14364 G14365 ... The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of ... Class II Cook Inc.
Jan 4, 2019 Heavy Duty PTFE Wire Guide, Guidewire, Global Product Number G14323 G14260 ... The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of ... Class II Cook Inc.
Jan 4, 2019 Angled Tip Ureteral Catheter Set, Ureteral Catheter, Global Product No. G14598 The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of ... Class II Cook Inc.
Jan 4, 2019 King LTS-D Kit Size 1, Model Number KLTSD431 Size 0 products were incorrectly packaged and labeled as a size 1 products. Class II King Systems Corp. dba Ambu, Inc.
Jan 4, 2019 Bentson PTFE Wire Guide, Guidewire, Global Product Number G14589, G14590 The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of ... Class II Cook Inc.
Jan 4, 2019 Roadrunner Hydrophilic PC Wire Guide, Guidewire, Global Product Number G18629... The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of ... Class II Cook Inc.
Jan 4, 2019 Urethral Dilator Set, Global Product No. G14185 The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of ... Class II Cook Inc.
Jan 4, 2019 Wire Guide, Guidewire, Global Product Number G14326 The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of ... Class II Cook Inc.
Jan 4, 2019 Kwart Retro-Inject Ureteral Stent Set, Global Product No. G15016 G14836 G1... The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of ... Class II Cook Inc.
Jan 4, 2019 Sof-Flex Double Pigtail Ureteral Stent Set, Global Product No. G15076 G1490... The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of ... 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.