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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
Aug 14, 2012 Varian brand Clinac, Trilogy, Novalis Tx, Unique, linear accelerators; Model ... Some X-jaw (lower collimator jaw) carriers were made using the incorrect metal alloy, which can c... Class II Varian Medical Systems, Inc. Oncology Systems
Aug 13, 2012 Progel Pleural Air Leak Sealant, Model #: PGPS002 Lot #: 111202-002 Produ... Product was distributed with an incorrect expiration date. Product was labeled with an expiratio... Class II Neomend Inc
Aug 9, 2012 Tip Cover for 8mm Monopolar Curved Scissors (Hot Shears)Accessory, Disposable... There is potential for the sterility of the product to be compromised. Class II Intuitive Surgical, Inc.
Aug 9, 2012 Embolectomy Catheters (Models A44XX, A4FXX, CE0XXXST, and CE0XXX): Model Num... Applied Medical is recalling specific lot numbers of its Vascular Catheters because they may have... Class II Applied Medical Resources Corp
Aug 9, 2012 Irrigation Catheters (Models IRR-XXX-XX): Model Numbers & Description: IR... Applied Medical is recalling specific lot numbers of its Vascular Catheters because they may have... Class II Applied Medical Resources Corp
Aug 9, 2012 Biliary Catheters (Models A47XX and CB0XXXXX): Model Numbers & Description: ... Applied Medical is recalling specific lot numbers of its Vascular Catheters because they may have... Class II Applied Medical Resources Corp
Aug 8, 2012 AutoPulse Resuscitation System Model 100, Mfg by:Zoll Circulation Sunnyva... Complaints associated with an unexpected stop in AutoPulse compressions. Class II Zoll Circulation, Inc.
Aug 6, 2012 Nidek Excimer Laser Corneal Surgery System, model EC-5000 CXIII. Opthalmic D... Contact failure in F1 and F4 fuse holders was detected on the EC-5000 CXIII Excimer Laser Corneal... Class II Nidek Inc
Aug 3, 2012 Newport HT70 and HT70 Plus Ventilators, Model Number: HT70 and HT70 Plus. ... May emit a continuous high priority alarm and the ventilator may stop ventilating, due to a compo... Class I Newport Medical Instruments Inc
Aug 3, 2012 HALO Flex Energy Generators Manufactured by B¿RRX Medical (now Covidien) ... Potential failure of HALO Energy Generator to enter "stand by" mode when initially powered on; an... Class II Covidien LLC
Jul 31, 2012 V60 Ventilator, Continuous Ventilator, Model# V60, PN 1056490 Product Usag... Respironics is recalling the V60 ventilator because certain blower motor assemblies in the V60 ve... Class I Respironics California Inc
Jul 24, 2012 Access Folate Calibrators, Part Number: A14207. The Access Folate assay is... Beckman Coulter is recalling the Access Folate Calibrators because it may produce falsely elevate... Class II Beckman Coulter Inc.
Jul 24, 2012 Access Folate WHO Calibrators, Part Number: A98033. The Access Folate Cali... Beckman Coulter is recalling the Access Folate Calibrators because it may produce falsely elevate... Class II Beckman Coulter Inc.
Jul 23, 2012 Cisco brand HealthPresence, version 2.1; Model/Catalog Number: CHP-ENTPRSYR2.... Software anomaly may result in incorrect values and interpretations. The initial vital signs read... Class II Cisco Systems Inc
Jul 13, 2012 INSTRUMENT ARM DRAPE IS2000, 20 PACK: Product Usage: The intended use ... Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have... Class II Intuitive Surgical, Inc.
Jul 13, 2012 KIT,DISPOSABLE ACCESSORY,3ARM,IS2000,5 PACK; Product Usage: The intend... Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have... Class II Intuitive Surgical, Inc.
Jul 13, 2012 KIT,DISPOSABLE ACCESSORY,4ARM,IS3000,5 PACK; Product Usage: The inten... Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have... Class II Intuitive Surgical, Inc.
Jul 13, 2012 ACCESSORY BASE STARTER KIT,IS3000; Product Usage: The intended use of... Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have... Class II Intuitive Surgical, Inc.
Jul 13, 2012 KIT,DISPOSABLE ACCESSORY,4ARM,IS2000,5 PACK; Product Usage: The intend... Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have... Class II Intuitive Surgical, Inc.
Jul 13, 2012 KIT,DISPOSABLE ACCESSORY,3ARM,IS3000,5 PACK; Product Usage: The intend... Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have... Class II Intuitive Surgical, Inc.
Jul 12, 2012 Alere Triage TOX Drug Screen 9 Panel, P/N: 94402. The Alere Triage TOX Dru... Alere San Diego is recalling Alere Triage TOX Drug Screen because there is a possibility that aft... Class II Alere San Diego, Inc.
Jul 11, 2012 ACUSON SC2000 ultrasound systems at software versions VA20A or VA20B. Model ... In certain situations, loss of post exercise images can occur in Stress Echo. Class II Siemens Medical Solutions USA, Inc.
Jul 9, 2012 IRISpec" CA/CB two-part urine chemistry control twin set, Iris Diagnostics pa... The firm recalled after it received complaints of IRISpec CA/CB two part Urine Chemistry Control,... Class III Iris Diagnostics
Jul 6, 2012 Unicel Closed Tube Aliquotter (UCTA) for UniCel DxC 660i, UniCel DxC 680i, Un... The recall was initiated because Beckman Coulter has confirmed that the current sample syringe pu... Class II Beckman Coulter Inc.
Jul 2, 2012 Varian brand Varian ARIA Oncology Information System, Import Export applicat... A software anomaly has been identified with the Import Export Application version 11.0 where MLC... Class II Varian Medical Systems, Inc. Oncology Systems
Jun 29, 2012 Alaris Pump Module model 8100. Subsequent product code: FPA The Pump mo... The recall was initiated because Carefusion identified a potential risk associated with the Alari... Class I CareFusion 303, Inc.
Jun 29, 2012 BD FACS 7-color Setup beads BD Biosciences, San Jose, CA 95131. BD FACS... Incorrect version of the CD was included with BD FACS 7 Color Setup Beads. Class II BD Biosciences, Systems & Reagents
Jun 28, 2012 STERRAD Cyclesure Biological Indicator (BI), P/N 14324 are sold in cases, pac... Advanced Sterilization Products (ASP) is recalling certain lots of the STERRAD CYCLESURE 24 Biolo... Class II Advanced Sterilization Products
Jun 26, 2012 Padded Swing Away Arm Rest with Receiver; Uses on wheelchair models: Quicki... Reports of injury when the Padded Swing Away Armrest is used for full body weight. Owner's manual... Class II Sunrise Medical (US) LLC
Jun 25, 2012 ARTISTE or ONCOR Digital Linear Accelerators with syngo RT Therapist version ... Potential safety issue when using the IMMEDIATE RESUMPTION feature after a Control Console interl... Class II Siemens Medical Solutions USA, Inc
Jun 19, 2012 Stryker brand Arthroscope and Hardware Set Tray (sterilization tray); Model/P... The gravity steam, Ethylene Oxide (EO) and STERRAD 100S sterilization methods are being removed f... Class II Stryker Endoscopy
Jun 19, 2012 STERRAD 100S Cassette, Batch # 12A077. The STERRAD 100S and STERRAD NX ste... Advanced Sterilization Products (ASP) is recalling (removing) the Sterrad 100S and Sterrad NX Sys... Class III Advanced Sterilization Products
Jun 19, 2012 STERRAD NX Cassette, Batch # 12A078. The STERRAD 100S and STERRAD NX steri... Advanced Sterilization Products (ASP) is recalling (removing) the Sterrad 100S and Sterrad NX Sys... Class III Advanced Sterilization Products
Jun 18, 2012 Varian brand Varian Eclipse Treatment Planning System for radiotherapy; Model... Varian has identified an anomaly with the Eclipse Treatment Planning (for radiotherapy treatments... Class II Varian Medical Systems, Inc. Oncology Systems
Jun 15, 2012 Alaris Pump Module Model 8100 (formerly Medley Pump Module) Subsequent Pro... The recall was initiated because Carefusion has identified a potential risk associated with the A... Class I CareFusion 303, Inc.
Jun 8, 2012 MOSAIQ Oncology Information Systems interfaced to Elekta Treatment machines. ... Impac Medical became aware of a problem with the recording of the Wedge Motor Units in MOSAIQ whe... Class II Impac Medical Systems Inc
Jun 6, 2012 ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) - ... The firm recalled because the glucose measurements from a patient sample that the customer felt w... Class II Sendx Medical Inc
Jun 1, 2012 I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Kit, Model #TB089T ... I-Flow initiated two voluntary product removals of the ON-Q Pain Relief System: T-Block Needle/Ca... Class II I-Flow LLC
Jun 1, 2012 I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Tray, Model #TBTB1089... I-Flow initiated two voluntary product removals of the ON-Q Pain Relief System: T-Block Needle/Ca... Class II I-Flow LLC
Jun 1, 2012 CIDEX OPA, High Level Disinfectant Solution, Glutaraldehyde-free (0.55% ortho... The recall was initiated because Advanced Sterilization Products has discovered instances of miss... Class II Advanced Sterilization Products
May 30, 2012 Adult Divided Cannula end tidal C)2 sampling w/male luer-lock connector. 7 f... A complaint was received, and later verified, that product labeled as SO-1296 with male luer lock... Class II SALTER LABS
May 29, 2012 TRESTLE LUXE¿ Anterior Cervical Plating System, Product code KWQ. 510(k) K102... On May 9th 2012 Alphatec Spine received a complaint which reported that the distal tip of the Tr... Class II Alphatec Spine, Inc.
May 25, 2012 Alaris PC unit model 8015 Product Usage: The device is labeled for prescr... The recall was initiated because the Alaris PC unit model 8015 has a component on the PC unit pow... Class I CareFusion 303, Inc.
May 23, 2012 LMA Esophageal Intubation Detector (EID), Catalog Number EID100 The device... The recall was initiated because LMANA has received a complaint that the Esophageal Intubation De... Class II LMA North America Inc
May 22, 2012 CYTO-STAT tetraCHROME CD45- FITC/CD56-RD1/CD19-ECD/CD3-PC5, Part Number 66070... The recall was initiated because Beckman Coulter has determined that the specimen and prepared sa... Class II Beckman Coulter Inc.
May 22, 2012 Alere Triage BNP PN 98000XR Intended to be used as an aid in the diagnosis... Certain lots of the affected products may have significantly decreased precision relative to the ... Class I Alere San Diego, Inc.
May 22, 2012 Alere Triage Cardiac Panel PN 97000HS Used for the quantitative determinat... Certain lots of the affected products may have significantly decreased precision relative to the ... Class I Alere San Diego, Inc.
May 22, 2012 Triage D-dimer PN 98100 Used as an aid in the assessment and evaluation of... Certain lots of the affected products may have significantly decreased precision relative to the ... Class I Alere San Diego, Inc.
May 22, 2012 TetraCXP Software System, Part Number A40051. Allows simultaneous identifi... The recall was initiated because Beckman Coulter has determined that the specimen and prepared sa... Class II Beckman Coulter Inc.
May 22, 2012 Alere Triage Profiler SOB Panel PN 97300 Used for the determination of cre... Certain lots of the affected products may have significantly decreased precision relative to the ... Class I Alere San Diego, 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.