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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

4,602 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4,602 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 4,602 FDA device recalls in CA.

Clear
DateProductReasonClassFirm
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.
Sep 19, 2019 Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/wing 5700LAX,... Fetal transducers distributed in advance of receiving 510(k) and international clearances. Class II Pacific Medical Group Inc.
Sep 12, 2019 Stryker, REF: 0250070460, 5.0 mm x 32 cm, Strykeprobe, Outer Sheath Replaceme... Potential diff. in the length of the sheath tube and the sheath/probe. A diff. in length could le... Class II Stryker Corporation
Sep 12, 2019 Stryker, REF: 0250070450, 5.0 mm x 45 cm, Strykeprobe, Outer Sheath Replaceme... Potential diff. in the length of the sheath tube and the sheath/probe. A diff. in length could le... Class II Stryker Corporation
Sep 12, 2019 CODAN SWAN-LOCK Swabable Needlefree Connector, Catalog #BC1000N, REF 16.7220,... Individual packages of connectors may have incomplete or bad seals which would compromise sterility. Class II Codan US Corporation
Sep 11, 2019 Respironics V680 Ventilator, Service # 850011, (OUS Only) Ventilator touchscreen may become frozen and fail to respond to touch commands. If a patient requ... Class II Respironics California, LLC
Sep 11, 2019 Ultrasound Transducer (M2736A), that may have been serviced with the followin... Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent com... Class II Pacific Medical Group Inc.
Sep 11, 2019 Button-Style Tocotransducer (Nautilus), 8-foot Cord 2264HAX, that may have be... Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent com... Class II Pacific Medical Group Inc.
Sep 11, 2019 Toco+ transducer with ECG/IUP capability (wired), that may have been serviced... Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent com... Class II Pacific Medical Group Inc.
Sep 11, 2019 Respironics RP-UI Assy, V60 Ventilators User Interface RP-Kits, REF/P/N: 45... Ventilator touchscreen may become frozen and fail to respond to touch commands. If a patient requ... Class II Respironics California, LLC
Sep 11, 2019 External Toco Transducer (M1355A), that may have been serviced with the follo... Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent com... Class II Pacific Medical Group Inc.
Sep 11, 2019 Respironics RP-Touch Screen, V60/V680 Ventilator Serviced with Touchscreen RP... Ventilator touchscreen may become frozen and fail to respond to touch commands. If a patient requ... Class II Respironics California, LLC
Sep 11, 2019 Loop-Style Ultrasound Transducer (Nautilus), 8-foot Cord 5700LAX, that may ha... Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent com... Class II Pacific Medical Group Inc.
Sep 11, 2019 Toco M2734A, that may have been serviced with the following: Pacific Medical ... Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent com... Class II Pacific Medical Group Inc.
Sep 11, 2019 Respironics V60 Ventilator, Service # 850008, REF: 1053613, 1053614, 1053617,... Ventilator touchscreen may become frozen and fail to respond to touch commands. If a patient requ... Class II Respironics California, LLC
Sep 11, 2019 Button-Style Ultrasound Transducer (Nautilus), 8-foot Cord 5700HAX, that may ... Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent com... Class II Pacific Medical Group Inc.
Sep 11, 2019 Toco MP Transducer (M2734B), that may have been serviced with the following: ... Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent com... Class II Pacific Medical Group Inc.
Sep 11, 2019 Microsurgical Operating Room Tables;7300B (18-350-70); Unintended tilting of the Tabletop MST 7300BX and incorrect operation due to infrared operating s... Class II Mizuho America, Inc.
Sep 11, 2019 Loop-Style Tocotransducer (Nautilus) 2264LAX, that may have been serviced wit... Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent com... Class II Pacific Medical Group Inc.
Sep 11, 2019 Microsurgical Operating Room Tables;7300BX (18-351-70). Unintended tilting of the Tabletop MST 7300BX and incorrect operation due to infrared operating s... Class II Mizuho America, Inc.
Sep 11, 2019 Ultrasound Transducer (M1356A), that may have been serviced with the followin... Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent com... Class II Pacific Medical Group Inc.
Sep 4, 2019 Opiate 300 Ng Reagent (OP 1 X 250) for use in conjunction with UniCel DxC 600... Cross-reactivity testing may not meet the claims indicated in the Opiate 300 ng (OP)Instructions ... Class II Beckman Coulter Inc.
Sep 4, 2019 MicroScan WalkAway-96 plus Instrument Instruments were manufactured with a shortened 30mL reagent draw straw which may result in reagen... Class II Beckman Coulter Inc.
Sep 4, 2019 MicroScan WalkAway-96 plus Reconditioned Instrument Instruments were manufactured with a shortened 30mL reagent draw straw which may result in reagen... Class II Beckman Coulter Inc.
Sep 4, 2019 Synchron Systems Opiate 2000 ng Reagent (OP2 1 x 250); catalogue no. 475006 f... Cross-reactivity testing may not meet the claims indicated in the Opiate 2000 ng (OP2) Instructio... Class II Beckman Coulter Inc.
Sep 4, 2019 MicroScan WalkAway-40 plus Reconditioned Instrument Instruments were manufactured with a shortened 30mL reagent draw straw which may result in reagen... Class II Beckman Coulter Inc.
Sep 4, 2019 MicroScan WalkAway-40 plus Instrument Instruments were manufactured with a shortened 30mL reagent draw straw which may result in reagen... Class II Beckman Coulter Inc.
Aug 28, 2019 NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant); R... The top label of article no. 37965, lot 12129104 (immediate packaging of endosseous dental implan... Class II Nobel Biocare Usa Llc
Aug 27, 2019 Karl Storz, Model # 11161C2, Flexible Neuroscope During a complaint investigation it was determined that an error was observed within the instruc... Class II Karl Storz Endoscopy
Aug 27, 2019 Karl Storz RHINO-LARYNGO-BRONCHO FIBERSCOPE, Model # 11005BC1 During a complaint investigation it was determined that an error was observed within the instruc... Class II Karl Storz Endoscopy
Aug 27, 2019 Karl Storz NEURO-FIBERSCOPE, Model # 11282BN1, Flexible Pediatric Neuroscope During a complaint investigation it was determined that an error was observed within the instruc... Class II Karl Storz Endoscopy
Aug 23, 2019 Pharos Excimer Laser, Model: EX-308 - Product Usage: The Pharos EX-308 Excime... At doses of less than 100 mJ, in custom and auto repeat modes, a software error in the excimer la... Class II Ra Medical Systems, Inc.
Aug 19, 2019 BD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument, REF: 654587, when us... Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (... Class II Becton, Dickinson and Company, BD Biosciences
Aug 19, 2019 BD FACSLyric Flow Cytometer, 2-Laser 6 Color Instrument, REF: 651165, when us... Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (... Class II Becton, Dickinson and Company, BD Biosciences
Aug 19, 2019 BD FACSLyric Flow Cytometer,3-Laser 10 Color Instrument, REF: 659180 and 6591... Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (... Class II Becton, Dickinson and Company, BD Biosciences

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.