Browse Device Recalls

4,538 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4,538 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 4,538 FDA device recalls in CA.

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DateProductReasonClassFirm
Jul 3, 2025 Orascoptic Superior Visualization Custom loupes with Dragonfly frames Due to complaints, loupe nose pads containing nickel may cause an allergic reaction. Class II Orascoptic Surgical Acuity
Jul 3, 2025 Orascoptic Superior Visualization Dragonfly Nose Pad Accessory Kit ( nose pa... Due to complaints, loupe nose pads containing nickel may cause an allergic reaction. Class II Orascoptic Surgical Acuity
Jul 3, 2025 Orascoptic Superior Visualization Phantom Nose Pad Accessory Kit ( nose pad ... Due to complaints, loupe nose pads containing nickel may cause an allergic reaction. Class II Orascoptic Surgical Acuity
Jul 3, 2025 t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobi... an app defect that occurs when the phone is set to a right-to-left language, which causes app-pu... Class II Tandem Diabetes Care, Inc.
Jul 3, 2025 Orascoptic Superior Visualization Dragonfly Essentials Kit ( Nose pad, a scr... Due to complaints, loupe nose pads containing nickel may cause an allergic reaction. Class II Orascoptic Surgical Acuity
Jun 26, 2025 UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205, Beckman Coulter identified that the Unsaturated Iron Binding Capacity (UIBC) assay is not meeting... Class II Beckman Coulter Inc.
Jun 25, 2025 NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662 Engaging titanium base was manufactured 180 degrees around the post from where it should be locat... Class II Preat Corp
Jun 24, 2025 Preat, Astra EV-compatible 4.2mm Digital Analog REF: 9006603 (single) and 90... Due to manufacturing error, digital analog rotational feature is 180 degrees off. Class II Preat Corp
Jun 23, 2025 Brand Name: HeartMate Product Name: Mobile Power Unit Model/Catalog Number:... Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking... Class I Thoratec LLC
Jun 23, 2025 Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/... Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking... Class I Thoratec LLC
Jun 18, 2025 Stryker, StrykeFlow , REF: 0250070500, 2, Disposable Suction/Irrigator withou... Due to complaints their is the potential that irrigation solution may leaked into the handpiece ... Class II Stryker Corporation
Jun 18, 2025 Stryker, StrykeFlow REF: 0250070520 / 2, Disposable Suction/Irrigator with Di... Due to complaints their is the potential that irrigation solution may leaked into the handpiece ... Class II Stryker Corporation
Jun 17, 2025 QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, ... Dipstick strep A test has potential for false positive results. Class II Quidel Corporation
Jun 16, 2025 InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users) Medtronic MiniMed, Inc. is recalling InPen App for iOS and Android users due to software design e... Class II Medtronic MiniMed, Inc.
Jun 13, 2025 Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P; PV.01... Reports of IVUS catheter and guide wire entanglement during radial-to-peripheral procedures, due ... Class II Volcano Corp
Jun 12, 2025 Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative m... A specific lot of bovine serum albumin (BSA) used for manufacturing of coated tubes (CT) that are... Class II Beckman Coulter Inc.
Jun 6, 2025 Superion IDS Kit Superion Indirect Decompression System 8MM, VF Implant 101... As a result of a comprehensive product performance review it was determine that the device and in... Class II Boston Scientific Neuromodulation Corporation
Jun 3, 2025 REF: 335775 , BD FACS, 7-Color Setup Beads, 25 setups per kit, Rx Only, IVD. ... Due to customer complaints, errors in spectral overlap factors table for 7-color setup beads ma... Class II Becton, Dickinson and Company, BD Bio Sciences
Jun 3, 2025 SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-... Due to a manufacturing issue, disinfecting cap for needle-free connectors may have an incomplete ... Class II ICU Medical, Inc.
Jun 3, 2025 REF: 666289 , BD FACS, 7-Color Setup Beads, 25 Runs, CE, IVD. Used in flow cy... Due to customer complaints, errors in spectral overlap factors table for 7-color setup beads ma... Class II Becton, Dickinson and Company, BD Bio Sciences
May 29, 2025 LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200; ... Drug Elutable Microspheres have a smaller actual average diameter that is not within specificatio... Class II MICROVENTION INC.
May 21, 2025 Bigfoot Unity Diabetes Management System SW-300689-01 Bigfoot Inject v1 Pen C... Due to a software/firmware issue diabetes management system may provide a device error and cause ... Class II BIGFOOT BIOMEDICAL
May 21, 2025 Newport HT70 Ventilator, REF: HT70M-JP-NA, HT70M-CN-NA, HT70M-ES-EU, HT70M-PT... Ventilator Printed Circuit Board Assembly may have two separate capacitors that may fail, which m... Class I Covidien
May 19, 2025 Brand Name: Hummingbird Product Name: Stimulated EMG Kit with Hummingbird - ... Product packaging contains the wrong part number and kit contents. Class II Neurovision Medical Products Inc
May 16, 2025 Brand Name: Q-Stop Product Name: Suture Retention Device Model/Catalog Number... XXX Class II Drs Vascular, Inc
May 14, 2025 Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannul... due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the... Class I Edwards Lifesciences, LLC
May 14, 2025 Brand Name: FEM-FLEXII Product Name: Femoral Arterial Cannula Model/Catalog... due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the... Class I Edwards Lifesciences, LLC
May 14, 2025 Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalo... due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the... Class I Edwards Lifesciences, LLC
May 14, 2025 Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalo... due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the... Class I Edwards Lifesciences, LLC
May 14, 2025 Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalo... due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the... Class I Edwards Lifesciences, LLC
May 14, 2025 Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannul... due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the... Class I Edwards Lifesciences, LLC
May 12, 2025 Dexcom G7 Glucose Receiver, SKUs (part number): STK-AT-011(MT26403-0), STK-... Defective foam or an assembly error may cause the receiver speaker to lose contact with the print... Class I Dexcom, Inc.
May 12, 2025 Dexcom G6 Glucose Receiver, SKUs (Part Number): STK-FM-001 (MT27408-1) & ST... Defective foam or an assembly error may cause the receiver speaker to lose contact with the print... Class I Dexcom, Inc.
May 12, 2025 Dexcom One Continuous Glucose Monitoring System, SKUs(Part Number): STK-DO-00... Defective foam or an assembly error may cause the receiver speaker to lose contact with the print... Class I Dexcom, Inc.
May 12, 2025 Dexcom One+ Continuous Glucose Monitoring System, SKU(Part Number): STK-D7-01... Defective foam or an assembly error may cause the receiver speaker to lose contact with the print... Class I Dexcom, Inc.
May 8, 2025 Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BL... Due to radiopaque (RO) marker was not visible during angiography and it was determined that the R... Class II BALT USA, LLC
May 8, 2025 BD Pyxis Product Name / UDI-DI code / Catalog No. BD Pyxis" MedStation" 400... Antivirus software was not consistently installed on impacted devices during the implementation p... Class II CareFusion 303, Inc.
May 8, 2025 Prestige Coil System REFs/UDI-DI codes: PRES0153CXPPLT 00810068567311 PRES1... Due to radiopaque (RO) marker was not visible during angiography and it was determined that the R... Class II BALT USA, LLC
May 8, 2025 Product Name [REF]: Supply Server, CCE Enterprise SW Site License (2-5), BD P... During automated dispensing cabinet upgrade/installation/reimaging, component manager was left in... Class II CareFusion 303, Inc.
May 7, 2025 Medtronic, Simplera Sensor, REF: MMT-5100JD1 The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and ... Class II Medtronic MiniMed, Inc.
May 6, 2025 HardyCHROM CRE, selective and differential culture medium for antimicrobial s... Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Kl... Class II Hardy Diagnostics
May 5, 2025 Dexcom G7 iOS Application, Ref: SW12300 used in conjunction with the Dexcom G... A bug in the 2.7.0 version of the G7 iOS App can cause the app to enter a state where it stops up... Class II Dexcom, Inc.
May 2, 2025 Brand Name: Canturio¿ Smart Extension Product Name: CSE Implant Model/Catal... Due to labeling error. Product incorrectly labeled. Class II Canary Medical, Inc.
May 1, 2025 The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used ... The Drill stop kit contains incorrect components. Class II Implant Direct Sybron Manufacturing LLC
Apr 25, 2025 Brand Name: Tecfen Medical Product Name: 2.4mm Slit Knife, Angled Model/Cat... Sterility assurance for Ophthalmic knives. Class II Tecfen Medical
Apr 25, 2025 Brand Name: Tecfen Medical Product Name: 2.2mm Slit Knife, Angled Model/Cat... Sterility assurance for Ophthalmic knives. Class II Tecfen Medical
Apr 25, 2025 Brand Name: Tecfen Medical Product Name: 20G (1.2mm) MVR Sideport Knife Stra... Sterility assurance for Ophthalmic knives. Class II Tecfen Medical
Apr 25, 2025 Brand Name: Tecfen Medical Product Name: 2.8mm Slit Knife, Angled Model/Cat... Sterility assurance for Ophthalmic knives. Class II Tecfen Medical
Apr 25, 2025 Brand Name: Tecfen Medical Product Name: 15 degree Stab Knife Model/Catalog... Sterility assurance for Ophthalmic knives. Class II Tecfen Medical
Apr 25, 2025 Brand Name: Tecfen Medical Product Name: 2.0mm Crescent Knife Angled Bevel U... Sterility assurance for Ophthalmic knives. Class II Tecfen Medical

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.