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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 5, 2018 | Thermoset Room Temperature Closed Loop Injectate Delivery System. 1 unit per... | Potential for leakage due to defect in the thermoset check valve component. | Class II | ICU Medical, Inc. |
| Oct 5, 2018 | Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 u... | Potential for leakage due to defect in the thermoset check valve component. | Class II | ICU Medical, Inc. |
| Oct 3, 2018 | Medtronic MiniMed 630G 6025805-003_C, Rx Only Medtronic MiniMed 670G 60258... | Reports of occurrences in which insulin pumps with version 4.10 software have failed to make expe... | Class II | Medtronic Inc. |
| Sep 28, 2018 | TriMed Wrist Hook Dorsal Impactor, REF IMPCT-WHD; and TriMed Wrist Hook Volar... | The WHD/WHV impactors can rust over time due to an improper manufacturing process. | Class II | TriMed Inc. |
| Sep 28, 2018 | TriMed Hex Driver 1.2, 55mm AO Cannulated, REF HXDRIVR-1.2C AO, nonsterile, R... | The epoxy on Apex manufactured epoxy-coated instruments can pop off. | Class II | TriMed Inc. |
| Sep 28, 2018 | TriMed Locking Drill Guide, 2.3mm, REF GUIDELCBS-2.3, nonsterile, Rx. The fi... | The epoxy on Apex manufactured epoxy-coated instruments can pop off. | Class II | TriMed Inc. |
| Sep 28, 2018 | TriMed Peg Guide Extender, REF PEG-XTNDR, nonsterile, Rx. The firm name on t... | The spring on the PEG-Extender can rust due to the type of steel used to manufacture it. | Class II | TriMed Inc. |
| Sep 28, 2018 | TriMed Countersink 1.7mm, HCS, REF HSINK-1.7, nonsterile, Rx. The firm name ... | The epoxy on Apex manufactured epoxy-coated instruments can pop off. | Class II | TriMed Inc. |
| Sep 25, 2018 | PRO-DEX Surgical Driver Battery Pack PDBP-001 Series PRO-DEX Battery Pack, S... | Visual particulates within a battery Tyvek pouch. The battery is provided sterile for use with s... | Class II | Pro-Dex Inc |
| Sep 24, 2018 | Disposable 25GA Vitrectomy Cutter, REF NGP0025, RX Only, Abbott Medical Optic... | Packaging error, 20GA Vitrectomy Cutter may be found in a 25GA package. Use of a Vitrectomy cutt... | Class II | Johnson & Johnson Surgical Vision Inc |
| Sep 18, 2018 | The Access Cortisol Reagent. REF (Catalog Number) 33600, Lot 831755. A param... | Cross contamination may have occurred between wells for the reagent pack. As a result of this def... | Class II | Beckman Coulter Inc. |
| Sep 17, 2018 | Kaluza C Flow Cytometry Software, RX Only in the U.S.A., Beckman Coulter, Inc... | Compatibility issue between the software and Microsoft updates to Windows 7, 8, and 10. The comp... | Class II | Beckman Coulter Inc. |
| Sep 6, 2018 | Implant Direct Scan Adapter Assembly Replant platform for the following part ... | The action is being initiated due to incorrect assembly of the scan adapter . The result of the i... | Class II | Implant Direct Sybron Manufacturing, LLC |
| Aug 24, 2018 | Beckman Coulter Uric Acid, REF OSR6098, OSR6198, and OSR6698. | NAPQI, a metabolite of Acetominophen, causes negative interference with the recalled product assa... | Class II | Beckman Coulter Inc. |
| Aug 24, 2018 | Beckman Coulter Lipase, REF OSR6130 and OSR6230. | NAPQI, a metabolite of Acetaminophen, causes negative interference with the recalled product assa... | Class II | Beckman Coulter Inc. |
| Aug 24, 2018 | TriMed Hex Cortical Screw 4.0, 40 mm, REF HEX4.0-40, non-Sterile, RX, a compo... | The bone screw is shorter than the intended design specification. | Class II | TriMed Inc. |
| 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 |
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.