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 |
|---|---|---|---|---|
| Jul 24, 2025 | Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: D... | The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iO... | Class I | Dexcom, Inc. |
| Jul 24, 2025 | Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dex... | The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iO... | Class I | Dexcom, Inc. |
| Jul 22, 2025 | RefleXion X1 Model RXM1000 UDI Codes: (01)00860003983812(11)230504(21)X1100... | Due to incorrect software configuration that potentially allows more than two (2) fractions withi... | Class II | Reflexion Medical, Inc. |
| Jul 21, 2025 | Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF:... | Insulin pumps manufactured with speakers from Revision A and B may malfunction ("Malfunction 16")... | Class I | Tandem Diabetes Care, Inc. |
| Jul 10, 2025 | Description/REF: BD PYXIS MEDBANK MINI 1FH-1FM/169-137, BD PYXIS MEDBANK MI... | Reports of delayed access to medication in automated dispensing cabinets because of the override/... | Class III | CareFusion 303, Inc. |
| Jul 8, 2025 | BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions | Infusion pump module used with compatible pump infusion sets may perform outside the establishe... | Class I | CareFusion 303, Inc. |
| Jul 8, 2025 | BD Alaris Pump Infusion Sets REF: 10013186, BD Alaris Pump Infusion Set, B... | Infusion pump module used with compatible pump infusion sets may perform outside the establishe... | Class I | CareFusion 303, Inc. |
| Jul 8, 2025 | BD Trucount Controls, 30 Test - REF: 340335 | Control kits contain incorrect standard deviation (SD) values for the low and high control beads ... | Class II | Becton, Dickinson and Company, BD Bio Sciences |
| Jul 8, 2025 | BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD | Control kits contain incorrect standard deviation (SD) values for the low and high control beads ... | Class II | Becton, Dickinson and Company, BD Bio Sciences |
| Jul 8, 2025 | Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Numb... | Wire break(s) have occurred in rechargeable deep brain stimulation implantable pulse generators, ... | Class II | Boston Scientific Neuromodulation Corporation |
| Jul 8, 2025 | Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M36... | Resistance and difficulties could occur while closing the retaining clip locking mechanism, which... | Class II | Boston Scientific Neuromodulation Corporation |
| Jul 3, 2025 | Orascoptic Superior Visualization Phantom Essential kit ( Nose pad, a screw... | Due to complaints, loupe nose pads containing nickel may cause an allergic reaction. | Class II | Orascoptic Surgical Acuity |
| Jul 3, 2025 | Orascoptic Superior Visualization Custom loupes configured with Phantom 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 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 | MicroScan Neg MIC 3J REF C54814 | Due to a manufacturing issue - missing a drug in well 4/4 but contain double the amount of antibi... | 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 |
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.