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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

4,606 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4,606 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 4,606 FDA device recalls in CA.

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DateProductReasonClassFirm
Nov 2, 2012 Sterile Rigid Tip Suction Wand The Suction Wands are indicated for use to ... California Medical Laboratories, Inc. has identified an issue with the Rigid Tip Suction Wand. D... Class II California Medical Laboratories Inc
Nov 1, 2012 Access Immunoassay System, Access 2 Immunoassay System, Synchron LXi 725 Cl... It has been determined that, in some cases, pulley drive components have broken parts or have be... Class II Beckman Coulter Inc.
Oct 31, 2012 Posey Biothane Restraint Cuffs, Catalog Number 2900. The device is intende... The firm voluntarily recalled Biothane Restraint Cuffs, Catalog No. 2900, that did not meet the r... Class II J T Posey Company
Oct 26, 2012 Beckman Coulter AU5800 Clinical Chemistry Analyzer, All Serial Numbers. An... Beckman Coulter is recalling the AU8500 Clinical Chemistry Analyzer because there is no labeling ... Class II Beckman Coulter Inc.
Oct 25, 2012 INTRABEAM Balloon Applicator Set; 4.0 cm, Carl Zeiss Meditec AG, Oberkochen... A manufacturing defect has been identified which could results in the small tube becoming dislodg... Class II Carl Zeiss Meditec, Inc.
Oct 25, 2012 BioPlant, a dental bone grafting material. BioPlant has been assigned the pr... The firm initiated the recall becaue disturbing the BioPlant product soon after it is placed may ... Class II Kerr Corporation
Oct 25, 2012 INTRABEAM Balloon Applicator Set; 3.0 cm, Carl Zeiss Meditec AG, Oberkochen... A manufacturing defect has been identified which could results in the small tube becoming dislodg... Class II Carl Zeiss Meditec, Inc.
Oct 25, 2012 INTRABEAM Balloon Applicator Set; 3.5 cm, Carl Zeiss Meditec AG, Oberkochen... A manufacturing defect has been identified which could results in the small tube becoming dislodg... Class II Carl Zeiss Meditec, Inc.
Oct 24, 2012 Superstat Modified Collagen Hemostatic Sponge.115mmx115mm Pledget, 1.5%, Part... The recall was initiated because Superstat Corporation has confirmed that no documentation are av... Class II Superstat Corp
Oct 24, 2012 Superstat Modified Collagen Hemostatic Sponge, 85mm x 85mm Pledget, 3.0%, Par... The recall was initiated because Superstat Corporation has confirmed that no documentation are av... Class II Superstat Corp
Oct 24, 2012 Superstat Modified Collagen Hemostatic Sponge, 32mm Disc, 1.5%, Part# 9120-15... The recall was initiated because Superstat Corporation has confirmed that no documentation are av... Class II Superstat Corp
Oct 24, 2012 Superstat Modified Collagen Hemostatic Sponge, 7.5mm x 19mm Cone, 3.0%, Part#... The recall was initiated because Superstat Corporation has confirmed that no documentation are av... Class II Superstat Corp
Oct 24, 2012 Superstat Modified Collagen Hemostatic Sponge, 115mm x 115mm Pledget, 3.0%, P... The recall was initiated because Superstat Corporation has confirmed that no documentation are av... Class II Superstat Corp
Oct 24, 2012 Superstat Modified Collagen Hemostatic Sponge, 2x2 Pledget, 3.0%, Part# 9106-... The recall was initiated because Superstat Corporation has confirmed that no documentation are av... Class II Superstat Corp
Oct 24, 2012 Superstat Modified Collagen Hemostatic Sponge, 50mm Disc, 3.0%, Part# 9200-30... The recall was initiated because Superstat Corporation has confirmed that no documentation are av... Class II Superstat Corp
Oct 24, 2012 Superstat Modified Collagen Hemostatic Sponge, 50mm Disc, 1.5%, Part# 9200-15... The recall was initiated because Superstat Corporation has confirmed that no documentation are av... Class II Superstat Corp
Oct 24, 2012 Nidek MC-500 Multicolor Laser Photocoagulator using software version 2.20. O... When the MC-500 is turned on and coagulation is performed without changing the laser color, the d... Class II Nidek Inc
Oct 24, 2012 Superstat Modified Collagen Hemostatic Sponge, 50mm Disc, 3.0%, Part# 9200-30... The recall was initiated because Superstat Corporation has confirmed that no documentation are av... Class II Superstat Corp
Oct 24, 2012 Superstat Modified Collagen Hemostatic Sponge, 2x2 Pledget, 1.5%, Part# 9105-... The recall was initiated because Superstat Corporation has confirmed that no documentation are av... Class II Superstat Corp
Oct 24, 2012 Superstat Modified Collagen Hemostatic Sponge, 85mm x 85mm Pledget, 1.5%, Par... The recall was initiated because Superstat Corporation has confirmed that no documentation are av... Class II Superstat Corp
Oct 24, 2012 Superstat Modified Collagen Hemostatic Sponge, 4x4 Pledget, 3.0%, Part# 9102-... The recall was initiated because Superstat Corporation has confirmed that no documentation are av... Class II Superstat Corp
Oct 24, 2012 Superstat Modified Collagen Hemostatic Sponge, 32mm Disc, 3.0%, Part# 9100-30... The recall was initiated because Superstat Corporation has confirmed that no documentation are av... Class II Superstat Corp
Oct 22, 2012 Alere Cholestech LDX Multianalyte Control, 2 vial set, Catalog Number: 88769 ... Out of range (increased) HDL Cholesterol results. Class III Alere San Diego, Inc.
Oct 22, 2012 Alere Cholestech LDX Calibration Verification, 4 vial set, Catalog Number: 88... Out of range (increased) HDL Cholesterol results. Class III Alere San Diego, Inc.
Oct 19, 2012 TriVascular brand Fill Polymer Kit, Endovascular Graft, Aneurysm Treatment Sy... Selected lots of the Fill Polymer Kit (European Model Number: TVFP14- B) in European distributor... Class II Trivascular, Inc
Oct 15, 2012 The SYMBIONIC LEG is an integrated prosthetic leg for transfemoral and knee d... OSSUR is recalling the Symbionic Leg because it is not recognizing the low battery warning signal... Class II Ossur Americas, Inc.
Oct 15, 2012 MRT-1504/A4 - Titan X MRI System MRT-30 I0A/5 - Titan 3T MRI System Produ... It was found that there is a problem with the LCD monitor used in the console. The LCD monitor ma... Class II Toshiba American Medical Systems Inc
Oct 10, 2012 PENTRA C200, Part Number: A11A01629. The Pentra C200 system is a fully aut... Horiba Medical is recalling the ABX PENTRA AST CP because during the AST application validation o... Class II Horiba Instruments, Inc dba Horiba Medical
Oct 10, 2012 ABX PENTRA AST CP, Part Number: A11A01629. The ABX Pentra AST CP reagent i... Horiba Medical is recalling the ABX PENTRA AST CP because during the AST application validation o... Class II Horiba Instruments, Inc dba Horiba Medical
Oct 3, 2012 West Nile Virus IgG DxSelect" kit Catalog No. EL0300G Kit Lots 122150, 12215... The firm recalled due to higher reactivity with some samples in the effected lots, which may refl... Class III Focus Diagnostics Inc
Oct 3, 2012 STERRAD CYCLESURE 24 Biological Indicator (BI) product, P/N 14324. Validat... Advanced Sterilization Products (ASP) is recalling all lots of Sterrad Cyclesure 24 Biological In... Class II Advanced Sterilization Products
Sep 28, 2012 3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod¿, Part Number (Item #)... ICU Medical, Inc. has identified a potential comingling of components where a 60 drop micro drip ... Class II ICU Medical, Inc.
Sep 27, 2012 VACUETTE Cellestis 1 ml QuantiFERON¿ - TB ANTIGEN; Shake 10x; REF 454074; HE0... Cellestis is recalling QuantiFERON¿¿ - TB Gold TB Blood Collection Tubes and HA TB Blood Collecti... Class II Cellestis Inc
Sep 27, 2012 Vacuette Cellestis 1 ml QuantiFERON¿ TB ANTIGEN (HA) High Altitude: Shake 10x... Cellestis is recalling QuantiFERON¿¿ - TB Gold TB Blood Collection Tubes and HA TB Blood Collecti... Class II Cellestis Inc
Sep 25, 2012 ILLlCO¿ MIS Posterior Fixation System, Bone-screw Internal Spinal Fixation S... The firm initiated the recall because the stainless steel guide-wire of the Illico MIS Fixation ... Class II Alphatec Spine, Inc.
Sep 24, 2012 ARIA Radiation Oncology, Version 11. Varian Medical Systems, Palo Alto, CA. T... An anomaly has been identified with the ARIA Oncology Information System Version 11 where Monitor... Class II Varian Medical Systems, Inc. Oncology Systems
Sep 20, 2012 STERRAD NX Cassettes, P/N 10133. The STERRAD NX sterilizations systems are... Advanced Sterilization Products is recalling three lots of STERRAD NX System Cassettes because it... Class II Advanced Sterilization Products
Sep 20, 2012 ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2 Horiba Medical is recalling ABX PENTRA ML because they have confirmed an issue with the ABX PENTR... Class II Horiba Instruments, Inc dba Horiba Medical
Sep 19, 2012 Male, 16Fr, Straight-tip Intermittent Urinary Catheters M16. The product is d... The firm initiated the product recall because labeling on some of the intermediate boxes of cathe... Class II Cure Medical LLC
Sep 19, 2012 Valiant Thoracic Stent Graft with Captivia Delivery System, Talent Thoracic ... Firm received reports of difficulty in flushing the graft cover of the delivery system during dev... Class II Medtronic Vascular, Inc.
Sep 18, 2012 Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Num... The firm initiated this recall because complaints from customers reported that the recovery comp... Class II Iris Diagnostics
Sep 14, 2012 ABX PENTRA Creatinine 120 CP, Model Number Creatinine Part # A11A01868, Lot N... This recall was initiated because some customers were experiencing an alarm during Creatinine cal... Class III Horiba Instruments, Inc dba Horiba Medical
Sep 14, 2012 Minotrol 16, Model Numbers: 2043748, 2043752, 2043756, Lot Number: MX090(Leve... HORIBA Medical Irvine Technical Support received reports from some customers that have experience... Class III Horiba Instruments, Inc dba Horiba Medical
Sep 7, 2012 Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped ... Devices labeled for an intended use not included in the existing 510(k) or PMA. Specifically, "Th... Class II Optovue Inc.
Sep 3, 2012 UniCel¿ DxC 600/800 with Software v5.0.11, Part Number B12218. The UniCel... Beckman Coulter has confirmed that the Shuttle to Barcode Reader and Cap Piercer alignment proce... Class II Beckman Coulter Inc.
Aug 24, 2012 Volcano brand Intravascular Ultrasound, Volcano s5/s5i Family Software Versio... The display on the system has the potential to change. In house testing eventually identified the... Class II Volcano Corporation
Aug 20, 2012 Armada 35/ Armada 35 LL PTA Catheters. The device is intended for dilatation ... Abbott Vascular is recalling the Armada 35 and Armada 35 LL PTA Catheters because they have disco... Class II Abbott Vascular
Aug 20, 2012 Thermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO; Liquid Assayed Integr... In house testing confirmed that CK-MS and Insulin claimed in both Omni IMMUNE and Omni IMMUNE PRO... Class III Microgenics Corporation
Aug 17, 2012 Varian brand Eclipse Treatment Planning System, Model Number: H48; Eclipse 8.... Varian has identified an anomaly with the Eclipse Treatment Planning where an outdated assigned H... Class II Varian Medical Systems, Inc. Oncology Systems
Aug 16, 2012 KARL STORZ Photodynamic Diagnosis (PDD) D-Light C System, Instruction Manual... The recall was initiated because Karl Storz has confirmed that the Photodynamic Diagnosis (PDD) D... Class II Karl Storz Endoscopy America 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.