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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.