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.

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DateProductReasonClassFirm
Aug 24, 2018 TriMed Dorsal Wrist Hook Plate, Dorsal, 4-Hole, REF WHD-4, contained in a tra... Modifications to the specification were not appropriately qualified through the company's design ... Class II TriMed Inc.
Aug 20, 2018 TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy ... Reports have been received of an anomaly that can result in a treatment without intended gating (... Class II Varian Medical Systems
Aug 20, 2018 ICU Medical 14" (36 cm) Appx 3.6 ml, Bifuse Transfer Set w/Rotating Luer, REF... Design change implemented changing the device from a blood set with a filter to a transfer set wi... Class II ICU Medical, Inc.
Aug 20, 2018 VitalBeam Radiotherapy Delivery System Version 2.5 Product Usage: The Vit... Reports have been received of an anomaly that can result in a treatment without intended gating (... Class II Varian Medical Systems
Aug 15, 2018 da Vinci X/Xi EndoWrist 8mm Monopolar Curved Scissors Model No. 470179-14 ... Monopolar Curved Scissor (MCS) instruments may be susceptible to developing cracks near the proxi... Class II Intuitive Surgical, Inc.
Aug 15, 2018 MassHunter Quantitative Analysis Software, Version B.07.01, used with Triple ... When utilizing specific software versions of an LC/MS device, and Batch at a Glance in Compound T... Class II Agilent Technologies, Inc.
Aug 15, 2018 TriMed Olecranon Hook Plate, Lt, 6-Holes, REF: OHOOKL-6, Non-Sterile, RX only... The firm has become aware that the angled-hole of certain semi-tubular design bone plates may hav... Class II TriMed Inc.
Aug 15, 2018 da Vinci S/Si EndoWrist 8mm Monopolar Curved Scissors Model No. 420179-16 ... Monopolar Curved Scissor (MCS) instruments may be susceptible to developing cracks near the proxi... Class II Intuitive Surgical, Inc.
Aug 10, 2018 ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL... The Distal Flush Tool (DFT) accessories that were packaged in this lot number are not compatible ... Class II Micro Therapeutics Inc, Dba Ev3 Neurovascular
Aug 8, 2018 ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mm... Two units in distribution were found to be mislabeled on the vial cap with the incorrect part num... Class II Implant Direct Sybron Manufacturing, LLC
Aug 7, 2018 Minimed Model 500 Remote Control (MMT-500, MMT-500RU, MMT-500RUS, MMT-500RSE,... There is a potential security vulnerability related to the use of the remote controller accessori... Class I Medtronic Inc.
Aug 7, 2018 Minimed Model 503 Remote Transmitter (MMT-503, MMT-503EU, MMT-503NA, MMT-503U... There is a potential security vulnerability related to the use of the remote controller accessori... Class I Medtronic Inc.
Aug 7, 2018 ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, R... The incorrect device was packaged in the vial. Class II Implant Direct Sybron Manufacturing, LLC
Jul 31, 2018 ENDOLOGIX AFX/AFX2, Limb (Iliac) Extension Endograft, Rx Only, Sterile EO, AF... Endologix is notifying physicians of patient tailored surveillance recommendations as well as gen... Class I Endologix
Jul 31, 2018 ENDOLOGIX AFX2 Bifurcated Endograft System, Stent Graft System, Rx Only, Ster... Endologix is notifying physicians of patient tailored surveillance recommendations as well as gen... Class I Endologix
Jul 31, 2018 ENDOLOGIX AFX Endovascular AAA System, Stent Graft System, Rx Only, Sterile E... Endologix is notifying physicians of patient tailored surveillance recommendations as well as gen... Class I Endologix
Jul 31, 2018 ENDOLOGIX AFX/AFX2, Proximal (Aortic) Extension Endograft, Rx Only, Sterile E... Endologix is notifying physicians of patient tailored surveillance recommendations as well as gen... Class I Endologix
Jul 30, 2018 UniCel DxH 900 Coulter Cellular Analysis System, REF number C11478 Product... Complaints received of sporadic erroneously elevated platelet results without flags or system mes... Class I Beckman Coulter Inc.
Jul 30, 2018 UniCel DxH 600 Coulter Cellular Analysis System, REF number B23858. Produc... Complaints received of sporadic erroneously elevated platelet results without flags or system mes... Class I Beckman Coulter Inc.
Jul 30, 2018 UniCel DxH 800 Coulter Cellular Analysis System, REF numbers 629029, B24465, ... Complaints received of sporadic erroneously elevated platelet results without flags or system mes... Class I Beckman Coulter Inc.
Jul 27, 2018 ZIMMER Oscillating Saw Blade -Cutting 75mm x 19mm x 1.00/1.27mm.intended for ... Mislabeled: Actual blade width is 19 mm but the label indicates a width of 25 mm. Class II Synvasive Technology Inc
Jul 25, 2018 HYTEC Stop Solution (Allergy), 300ml bottle containing 1N sodium hydroxide so... Some of the Stop Solution bottles, a caustic solution, have been reported to leak. Class II Hycor Biomedical LLC
Jul 18, 2018 The Shockwave S4 IVL Catheters are intended for lithotripsy-enhanced balloon ... Catheter unable to maintain inflation pressure during treatment (4ATM) and/or during IVL post dil... Class II Shockwave Medical, Inc.
Jul 16, 2018 da Vinci Si/X/Xi Surgical System Redundant Medical Grade Power Supply (RMGPS)... Certain Redundant Medical Grade Power Supply (RMGPS) units specific to Surgeon Console and Patien... Class II Intuitive Surgical, Inc.
Jul 13, 2018 Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution Immersion time stated on the bottle is 45 minutes while the product instructions say 90 minutes. Class II Kerr/Pentron, DBA Kerr Corporation and Pentron ...
Jul 11, 2018 POM Procedural Oxygen Masks, Endoscopic, Conscious Sedation, Bronchoscopy Mas... Complaints were received on the product, such as the re-breather bag would not fill/inflate or th... Class II POM Medical LLC
Jul 6, 2018 UroLift System REF Catalog Number: UL400-4 Tray Contents: UroLift System wi... Upon implant deployment, the Capsular Tab may not be delivered as the needle is retracted. In th... Class II Neotract Inc
Jul 4, 2018 Guardian Connect App CSS7200 used on the iPhone, iPad, and iPod Touch devices. The application may be closed by the operating system without alerting the user the app is no lon... Class II Medtronic Inc.
Jul 3, 2018 PLUS 30 PRIORITY PACK Accessory Kit Product Usage: Is recommended for use... Incorrect expiration being entered for one lot. Class II Abbott Vascular
Jul 3, 2018 ABL800 analyzer, model numbers 393-800 and 393-801. The analyzer software may cause a mis-match of patient demographics and test results when a certa... Class II Radiometer America Inc
Jul 2, 2018 Product: ABL800 FLEX with Crea. The ABL800 with Crea is available in the foll... From three incidents in Denmark and Sweden, comparison studies on patient blood samples carried o... Class II Radiometer America Inc
Jun 25, 2018 This is an accessory to Intelect Advanced, Intelect Mobile, Intelect Neo, and... The device accessories were not labeled with appropriate latex warning. Class II DJO, LLC
Jun 21, 2018 Ossur, LIL Angel Vest, Part/ Description: 545100K/ LIL ANGEL VEST P2 KOD... Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm M... Class II Ossur Americas
Jun 21, 2018 Ossur, Sterile, Part/ Description: 505300T/ CB RING KIT TI SM; 505300V2... Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm M... Class II Ossur Americas
Jun 21, 2018 Abbott TECNIS 1-Piece Aspheric Acrylic IOL with the TECNIS iTEC Preloaded Del... Expired intraocular lenses were distributed. Class II Johnson & Johnson Surgical Vision Inc
Jun 21, 2018 Ossur, J Tong, Sterile, Part/ Description: JT-115/ J TONG MED/LGE-No App... Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm M... Class II Ossur Americas
Jun 21, 2018 Ossur Skull Pin, Sterile Ceramic Tip Pin, Part/ Description: 516CS/ Skul... Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm M... Class II Ossur Americas
Jun 21, 2018 Ossur OB Resolve, Sterile, Part/ Description: 505300D/ OB RESOLVE STERIL... Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm M... Class II Ossur Americas
Jun 21, 2018 Ossur CB Resolve, Sterile, Part/ Description: 505300C/ CB RESOLVE STERIL... Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm M... Class II Ossur Americas
Jun 21, 2018 Ossur, ReSolve Halo Vest, Part/ Description: 545700K/ ReSolve Halo Vest-... Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm M... Class II Ossur Americas
Jun 21, 2018 Ossur Skull Pin, Sterile Titanium Pin, Part/Description: 516TS/ Skull Pi... Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm M... Class II Ossur Americas
Jun 15, 2018 TRINIAS Digital Angiographic System intended to be used for cardiac angiograp... Due to a software issue the C-arm may unexpectedly moved when being moved to the park position an... Class II Shimadzu Medical Systems Usa Com
Jun 14, 2018 RT-5100 Refractor, a component of the Epic-5100 System. The lens bonding was incomplete on the refractor. Class III Nidek Inc.
Jun 11, 2018 Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm SAPIEN 3 THV was packaged with the incorrect valve size with respect to the label. Class II Edwards Lifesciences, LLC
Jun 8, 2018 Synchro2, 0.014in x 200cm, SOFT PRE-SHAPED Guidewire with Hydrophilic Coatin... The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.0... Class II Stryker Neurovascular
Jun 8, 2018 Synchro2, 0.014in x 300cm SOFT Guidewire with Hydrophilic Coating , UPN Produ... Class II Stryker Neurovascular
Jun 8, 2018 Synchro2, 0.014in. x 200cm STANDARD PRE-SHAPED Guidewire with Hydrophilic Coa... The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.0... Class II Stryker Neurovascular
Jun 8, 2018 Synchro2, 0.014in x 300cm STANDARD Guidewire with Hydrophilic Coating UPN Pro... The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.0... Class II Stryker Neurovascular
Jun 8, 2018 Synchro2, 0.014in x 300cm STANDARD PRE-SHAPED Guidewire with Hydrophilic Coat... The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.0... Class II Stryker Neurovascular
Jun 8, 2018 Synchro2, 0.014in x 200cm STANDARD Guidewire with Hydrophilic Coating, UPN Pr... The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.0... Class II Stryker Neurovascular

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.