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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

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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

4,686 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4,686 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 4,686 FDA device recalls in CA.

Clear
DateProductReasonClassFirm
Nov 14, 2019 Optium EZ Blood Glucose Monitoring System, UDI: 00093815710653 Instructions sent in a letter or in instructions for use for disinfecting blood glucose and/or ke... Class II Abbott Diabetes Care, Inc.
Nov 14, 2019 Precision Xtra Blood Glucose & Ketone Monitoring System, UDI: 00093815715023,... Instructions sent in a letter or in instructions for use for disinfecting blood glucose and/or ke... Class II Abbott Diabetes Care, Inc.
Nov 7, 2019 iChem VELOCITY Urine Chemistry Analyzer Beckman Coulter has become aware of an issue affecting Specific Gravity chemistry settings for th... Class II Beckman Coulter Inc.
Nov 6, 2019 The FastPack System Comlete Immunoassay Kit Immunoassay for the Quantitati... The chemiluminescent immunoassay has been noted to have higher than expected results which may re... Class II Qualigen Inc
Nov 6, 2019 NATRELLE Resterilizable Sizers for the styles and sizes: Style 15, Style 20, ... The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-... Class III Allergan PLC
Nov 6, 2019 Natrelle Inspira Sillicone-Filled Breast Implants for the following Styles an... The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-... Class III Allergan PLC
Nov 6, 2019 Natrelle Saline-Filled Breast Implant, for the following Styles and sizes, St... The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-... Class III Allergan PLC
Nov 6, 2019 Natrelle Silicone Filled Breast Implants for the following Styles and Sizes: ... The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-... Class III Allergan PLC
Nov 4, 2019 Trinias DAP Meter, a component of the Digital Anglo System Trinias contained ... The DAP meters were found to be outside of tolerance. Class II Shimadzu Medical Systems
Oct 30, 2019 XEN Gel Stent, REF 5513-001(US Model), Sterile, RX Only, (01)10888628032439 ;... Residual polishing compounds, that are used in the needle sleeve manufacturing process, may be pr... Class II Allergan PLC
Oct 28, 2019 iQ200 Series Urine Microscopy Analyzer, Catalog numbers: 700-3345, 700-3375,... Customers have reported incidents where two sets of results report the same Specimen Identifier (... Class II Beckman Coulter Inc.
Oct 28, 2019 iChemVELOCITY, Urine Chemistry System, Catalog numbers: 700-7176-001, 700-71... Customers have reported incidents where two sets of results report the same Specimen Identifier (... Class II Beckman Coulter Inc.
Oct 24, 2019 Bard Embolectomy Catheter & 1 ml SYRINGE, REF numbers/UDI: CE0340DR/(01)H69... The firm has received reports of tip separation during usage of the catheters, which may expose ... Class I Applied Medical Resources Corp
Oct 24, 2019 Applied Medical Dual Lumen Graft Cleaning Catheter & 1cc SYRINGE Nonpyrogenic... The firm has received reports of tip separation during usage of the catheters, which may expose ... Class I Applied Medical Resources Corp
Oct 24, 2019 Python Embolectomy Catheters, Sterile EO, CE, Ref numbers/UDI: A4E01/(01)0060... The firm has received reports of tip separation during usage of the catheters, which may expose ... Class I Applied Medical Resources Corp
Oct 23, 2019 GENTLEWAVE REF: FG-002-0001 The console would continue to run for extended period when the foot pedal was released. Class II Sonendo Inc
Oct 22, 2019 EZ Glide Aortic Cannula, 24 Fr. (8.0mm) x 37.6 cm (14.8") 3/8" (9.5 mm) vente... Their is a possibility that the cannula may separate from its connector, potentially causing a br... Class II Edwards Lifesciences, LLC
Oct 21, 2019 MicroScan WalkAway-96 plus Instrument REF B1018-284 WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet wi... Class II Beckman Coulter Inc.
Oct 21, 2019 MicroScan WalkAway-96 plus Reconditioned Instrument REF B1018-396R WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet wi... Class II Beckman Coulter Inc.
Oct 21, 2019 MicroScan WalkAway-40 plus Reconditioned Instrument REF B1018-340R WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet wi... Class II Beckman Coulter Inc.
Oct 21, 2019 DxM 1040 MicroScan WalkAway Instrument REF B1018-440 WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet wi... Class II Beckman Coulter Inc.
Oct 21, 2019 DxM 1096 MicroScan WalkAway Instrument REF B1018-496 WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet wi... Class II Beckman Coulter Inc.
Oct 21, 2019 MicroScan WalkAway-40 plus Instrument REF B1018-283 WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet wi... Class II Beckman Coulter Inc.
Oct 18, 2019 CapsoCAM Plus, UDI: 00867770000209 Capsule Endoscopy System: a defect present in the capsule window may be stressed through the prod... Class II Capso Vision, Inc.
Oct 14, 2019 Levo Arm Label: LEVO ARM REF 7887-050 MIZUHO OSI Refurbished Levo Arm Labe... Due to the potential for fluid ingress into the Arm which could affect the device's electrical sy... Class II Mizuho OSI
Oct 11, 2019 The PolarCath Balloon Catheter consists of a coaxial catheter shaft with two ... Peripheral Dilation Catheters that were E-Beam Sterilized were inadvertently mislabeled with EO s... Class II Nucryo Vascular Inc.
Oct 11, 2019 Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, S... Through a customer complaint and and internal investigation it was determined that some implant p... Class II Implant Direct Sybron Manufacturing LLC
Oct 10, 2019 4plus Streptavidin HRP Label, Conjugated Streptavidin Horseradish Peroxidase... Firm has identified product has no staining. If used, may result in invalid test results when use... Class II Biocare Medical, LLC
Oct 10, 2019 Panther Fusion Extraction Reagent-S, Ref PRD-04331, IVD, CE, Rx Only consisti... Reagent component included in flu test kit may cause both high background signal in a true negati... Class II Hologic, Inc
Oct 7, 2019 Oxymetry Cable, Rxonly. REF/UDI: HEMOXSC100/(01)00690103196986 - Product Usag... Intermittent communication due to inconsistent crimping of connectors onto cables. Class II Edwards Lifesciences, LLC
Oct 7, 2019 Star 8 Rolling Walker/Rollator, Items: 4258/ BK(Black)/ BL(Blue)/ DB(Sky Blue... Walkers within the identified serial range have the potential for the front fork to unscrew itsel... Class II Nova Ortho-Med Inc
Oct 7, 2019 Legacy 3 Implant, Size: 4.2mmD x 13mmL, 3.5mmD Platform, REF: 864213 Some dental implant packages contain incorrect implants, which could lead to surgery rescheduling. Class II Implant Direct Sybron Manufacturing LLC
Oct 4, 2019 REF: B9900-287, 82" (208 cm) Appx 10.4 ml, 10 Drop Admin Set, w/Pre-Slit Port... There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of ... Class II ICU Medical, Inc.
Oct 4, 2019 REF: Z3806, 131" (333 cm) 10 Drop Primary Set w/2 MicroClave, Remv 4 Gang 4-w... There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of ... Class II ICU Medical, Inc.
Oct 4, 2019 REF: Z3239, 126" 10 Drop Primary Set w/3 MicroClave, 2 Gang 4-Way Stopcocks, ... There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of ... Class II ICU Medical, Inc.
Oct 4, 2019 REF: MC330424, 145" (368 cm) Appx 19.8 ml, 10 Drop Primary Set w/4 MicroClave... There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of ... Class II ICU Medical, Inc.
Oct 4, 2019 REF: B30211, 37" (94 cm) Appx 4.2 ml, 10 Drop Admin Set W/Luer Lock, Bag Hang... There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of ... Class II ICU Medical, Inc.
Oct 4, 2019 REF: AH7117 111" 10 Drop Admin Set w/2 Inj Sites, Rotating Luer, Sterile R, F... There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of ... Class II ICU Medical, Inc.
Oct 4, 2019 REF: Z2850, 112" (284 cm) 10 Drop Primary set w/2 Clave, Remv 3 Gang 1o2 Mani... There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of ... Class II ICU Medical, Inc.
Oct 4, 2019 REF: B90240-50, 96" (244 cm) Appx 11.2 ml, 10 Drop Admin Set w/Coiled Tubing,... There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of ... Class II ICU Medical, Inc.
Oct 4, 2019 REF: Z2560, 100" 10 Drop Admin Set w/Hand Pump, 2 Clave", Rotating Luer, 1 Pr... There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of ... Class II ICU Medical, Inc.
Oct 4, 2019 REF: Z2812, 121" 10 Drop Primary Set w/5 MicroClave, Remv 2 Gang 4-Way Stopco... There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of ... Class II ICU Medical, Inc.
Sep 24, 2019 MOSAIQ, oncology information system - Product Usage: MOSAIQ is an oncology in... The user may inadvertently enter Metric values into Height and Weight fields labeled with US Stan... Class II Elekta Impac Software
Sep 19, 2019 Pacific Medical GE Corometrics Nautilus Ultrasound, 5700 (Old Style), FFCM5660 Fetal transducers distributed in advance of receiving 510(k) and international clearances. Class II Pacific Medical Group Inc.
Sep 19, 2019 Pacific Medical GE Corometrics Nautilus Toco Transducer w/knob, 2264HAX, FFCM... Fetal transducers distributed in advance of receiving 510(k) and international clearances. Class II Pacific Medical Group Inc.
Sep 19, 2019 Pacific Medical GE Corometrics Nautilus Toco Transducer w/wing (2264LAX), FFC... Fetal transducers distributed in advance of receiving 510(k) and international clearances. Possib... Class II Pacific Medical Group Inc.
Sep 19, 2019 Pacific Medical Philips M1356A Ultrasound Transducer with belt/wire knob, FFP... Fetal transducers distributed in advance of receiving 510(k) and international clearances. Class II Pacific Medical Group Inc.
Sep 19, 2019 Pacific Medical Philips M1355A Toco Transducer with belt wire/knob, FFPH3250 Fetal transducers distributed in advance of receiving 510(k) and international clearances. Class II Pacific Medical Group Inc.
Sep 19, 2019 Ra Medical Systems DABRA Catheter 5F (1.5mm), REF: 1222-5000-01, LOT: 18-0904... The firm has become aware there is a potential problem with its DABRA catheters resulting in high... Class II Ra Medical Systems, Inc.
Sep 19, 2019 Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/knob, 5700HAX... Fetal transducers distributed in advance of receiving 510(k) and international clearances. Class II Pacific Medical Group 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.