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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
Aug 8, 2015 Fundus Grasper; used with the da Vinci Si Surgical System (IS3000); Model nu... In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip ... Class II Intuitive Surgical, Inc.
Aug 4, 2015 NebuTech Nebulizer, Model number: Series 8660, 8960, 8961, 8966, 8984. Nebuli... The Inspiratory valve cap on the nebulizer reservoir tower may be loose and may detach before or ... Class II Salter Labs
Jul 31, 2015 Voyant Open Fusion Device Models: EB040 and EB040+ Product Usage: The Ap... Potential to improperly characterize tissue within the jaws, which may result in nonoptimal power... Class II Applied Medical Resources Corp
Jul 31, 2015 Edwards Pressure Monitoring Kit with TruWave disposable pressure transducer. ... Flow restriction issues in a trifurcated IV set included in the pressure transducer kits. A restr... Class II Edward Lifesciences, Llc
Jul 30, 2015 AU480 Chemistry Analyzers, Reference No. B28624 The AU series are automated,... Beckman coulter has received complaints regarding leaking and cracked C cups. When the cup cracks... Class II Beckman Coulter Inc.
Jul 30, 2015 AU5800 Chemistry Analyzers, Reference No. A98352 The AU series are automated... Beckman coulter has received complaints regarding leaking and cracked C cups. When the cup cracks... Class II Beckman Coulter Inc.
Jul 30, 2015 AU680 Chemistry Analyzers, Reference No. B04779 The AU series are automated,... Beckman coulter has received complaints regarding leaking and cracked C cups. When the cup cracks... Class II Beckman Coulter Inc.
Jul 28, 2015 Access Thyroglobulin Assay; 100 determinations, 2 packs, 50 tests/pack. For t... Beckman Coulter, Inc. is recalling Access Thyroglobulin reagent packs because some may exhibit gr... Class II Beckman Coulter Inc.
Jul 27, 2015 Xpert CT/NG Urine Specimen Collection Kit Part number GXCT/NGURINE-50; Mi... Firm determined that some lots of CT/NG Swab 50 and CT/NG Urine collection kits contain a sub com... Class III Cepheid
Jul 27, 2015 Xpert CT /NG Vaginal/Endocervical/ Specimen Collection Kit: Part number CT/N... Firm determined that some lots of CT/NG Swab 50 and CT/NG Urine collection kits contain a sub com... Class III Cepheid
Jul 27, 2015 CIDEX Activated Dialdehyde Solution, 4 bottles/case, P/N: 2266 Advanced Sterilization Products (ASP) is recalling the CIDEX Activated Dialdehyde Solution becaus... Class II Advanced Sterilization Products
Jul 27, 2015 Quickie IRIS Wheelchair. model EIZ4-2 in combination with option code 183M02 ... Quickie IRIS and Zippie IRIS tilt-in-space wheelchairs with MONO Backrest System with Dynamic Bac... Class II Sunrise Medical (US) LLC
Jul 27, 2015 Zippie IRIS Wheelchair. model EIZ5A in combination with option code 188M02 - ... Quickie IRIS and Zippie IRIS tilt-in-space wheelchairs with MONO Backrest System with Dynamic Bac... Class II Sunrise Medical (US) LLC
Jul 22, 2015 COULTER LH Series Diluent, Catalog No. 8547194, Product Labeling A40192-AD. ... Beckman Coulter is recalling the LH 750 and LH780 Hematology Systems because the use of the dilue... Class II Beckman Coulter Inc.
Jul 22, 2015 COULTER ISOTON 4 Diluent, Catalog No. 8547148. The diluent provides the abil... Beckman Coulter is recalling the LH 750 and LH780 Hematology Systems because the use of the dilue... Class II Beckman Coulter Inc.
Jul 22, 2015 Guardian Real-Time Monitor, Model No. CSS7100. Indicated for continuous or p... Medtronic MiniMed is recalling the Guardian Real-Time Continuous Glucose Monitoring System becaus... Class II Medtronic MiniMed Inc.
Jul 22, 2015 Volcano Pioneer Plus Re-Entry Catheter; Product Code PPLUS20, Catheter for C... Due to a manufacturing defect, there is the possibility that a small wire could extend through th... Class II Volcano Corporation
Jul 21, 2015 Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affect... Channel Error code is displayed on the PC unit with an audio and visual alarm, and on the syring... Class I CareFusion 303, Inc.
Jul 17, 2015 MicroScan LabPro Information Manager System, Version 1.0 to Version 4.11, Cat... The software incorrectly allows the operator to manually edit the carbohydrate substrates when ma... Class II Beckman Coulter Inc.
Jul 17, 2015 Wall Chart for STERRAD 100NX System, P/N 10104. The STERRAD 100NX Steriliz... Advanced Sterilization PRoducts (ASP) is recalling the Wall Chart for STERRAD 100NX System becaus... Class II Advanced Sterilization Products
Jul 17, 2015 BD CD56 PE Cy 7: NCAM16.2 ASR Analyte Specific Reagent, Catalog number 33580... Three lots of CD56 PE Cy 7, Catalog number 335809, contain a low amount of HLA-DR PE antibody whi... Class II Becton, Dickinson and Company, BD Biosciences
Jul 16, 2015 Radiometer Fixation Kit N20 for the TCM CombiM monitoring system, REF 905-873... When the fixation ring is taken off the paper liner there is a potential for fractions of the pap... Class II Radiometer America Inc
Jul 15, 2015 iChemVELOCITY Automated Urine Chemistry Catalog No. 800-3049, 800-3050, 800-3... Iris International is recalling the iChemVELOCITY systems because they do not maintain the on-boa... Class II Iris Diagnostics
Jul 15, 2015 EnVeo R Loading System, Model No. LS-EnVeoR-23, LS-EnVeoR-2629, LS-EnVeoR-23-... Medtronic is recalling the EnVeo R Loading Systems because of the presence of particulate. Class I Medtronic Cardiovascular Surgery-the Heart Valv...
Jul 9, 2015 HardyCHROM MRSA Cat no: G307 Lot no: H15155 Expires: 2015-08-13 Container... Hardy Diagnostics is recalling HardyCHROm MRSA due to a report of the potential for breakthrough ... Class II Hardy Diagnostics
Jul 2, 2015 Silhouette Lift brochure Silhouette Sutures are for use in midface suspens... Silhouette Lift is recalling the Silhouette Suture brochure because it does not include a comple... Class II Silhouette Lift, Inc.
Jul 1, 2015 iovera 155 Smart Tip; Catalog numbers:STT0412-10 and STT0412-5 (10 and 5 c... The expiration date on the outer box label and the pouch label for the iovera Smart Tip product i... Class II Myoscience Inc
Jun 29, 2015 ACUSON S Family ultrasound systems utilizing the 18L6 HD and/or 6C1 HD biopsy... When using the CIVCO biopsy attachments in combination with the ACUSON S Family on-screen guideli... Class II Siemens Medical Solutions USA, Inc.
Jun 26, 2015 Hardy Diagnostics BEA Broth with Vancomycin container type: 13x100mm tube... Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with... Class II Hardy Diagnostics
Jun 26, 2015 Hardy Diagnostics MDR Acinetobacter container type: 15x100mm monoplate p... Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with... Class II Hardy Diagnostics
Jun 26, 2015 Hardy Diagnostics BEA Agar with Vancomycin container type: 15x100mm monop... Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with... Class II Hardy Diagnostics
Jun 26, 2015 Hardy Diagnostics MacConkey Agar with CiPRP, 1ug/ml Container type: 15x10... Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with... Class II Hardy Diagnostics
Jun 26, 2015 Hardy Diagnostics BHI with CIPRO, 1ug/ml container type: 16x100mm tube p... Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with... Class II Hardy Diagnostics
Jun 26, 2015 Hardy Diagnostics BEA Agar with VGA container type: 15x100mm monoplate p... Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with... Class II Hardy Diagnostics
Jun 26, 2015 Hardy Diagnostics VRE Broth, 5ml container type: 16x100mm tube packaged:... Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with... Class II Hardy Diagnostics
Jun 25, 2015 ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ op... Potential measurement error on ACUSON S Family ultrasound system. When repositioning the Virtual ... Class II Siemens Medical Solutions USA, Inc.
Jun 25, 2015 ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with softw... Potential measurement error on ACUSON S Family ultrasound system when using the Doppler manual t... Class II Siemens Medical Solutions USA, Inc.
Jun 24, 2015 HardyCHROM VRE Agar-RSR Cat no: GA333 Lot no: H15055 Expires: 2015-07-04 ... Hardy Diagnostics is recalling HardyCHROM VRE Agar due to lack of 510(k) clearance. Class II Hardy Diagnostics
Jun 22, 2015 Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 an... A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certa... Class II Volcano Corporation
Jun 22, 2015 Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 an... A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certa... Class II Volcano Corporation
Jun 22, 2015 Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 an... A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certa... Class II Volcano Corporation
Jun 22, 2015 Volcano s5/s5i/CORE Intravascular Ultrasound Systems with software versions 3... A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certa... Class II Volcano Corporation
Jun 22, 2015 Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 an... A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certa... Class II Volcano Corporation
Jun 22, 2015 Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 an... A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certa... Class II Volcano Corporation
Jun 22, 2015 Abutment Retrieval Instrument Zirconia CC RP/WP, Article No. 37882 and Abutme... One dimension of the affected instrument is incorrect. Therefore this instrument cannot be used t... Class II Nobel Biocare Usa Llc
Jun 19, 2015 MiniMed NGP 640G 1.8ml (mmol/L), Model No. MMT-1511; NGP 640G 1.8ml (mg/dL), ... Medtronic MiniMed is recalling the MiniMed 620G and 640G insulin pumps because there are certain ... Class II Medtronic MiniMed Inc.
Jun 18, 2015 Natrelle CUI Series Tissue Expanders. Product Usage: Natrelle CUI Series ... Allergan is recalling the NATRELLE 133 and CUI Series Tissue Expanders because the products shipp... Class II Allergan Inc
Jun 18, 2015 Natrelle 133 Series Tissue Expanders Product Usage: Natrelle 133 Series T... Allergan is recalling the NATRELLE 133 and CUI Series Tissue Expanders because the product shippe... Class II Allergan Inc
Jun 17, 2015 Mission -Breath Alcohol Detector -15 tests - 0.08% BAC - Blow bags inc... Acon Laboratories, Inc. is recalling Mission Breath Alcohol Detector due to a labeling amendment. Class III Acon Laboratories, Inc.
Jun 17, 2015 Bond Elut OMS (Dried Matrix Spotting)' Product; Catalog model numbers: 50... The product was marketed without 510(k) clearance. Class II Agilent Technologies, 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.