Browse Device Recalls
35,290 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,290 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 35,290 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 4, 2025 | ADVIA¿ 120/2120/2120i SETpoint Calibrator | Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematol... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jun 4, 2025 | UROSKOP Omnia. Model Number: 10094910 | A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housi... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 4, 2025 | ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control) | Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematol... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jun 3, 2025 | BD Heyman Follower Coude Tip for following sizes: 12Fr - REF:021312 14Fr... | Cather packaging may contain the incorrect French size. | Class II | C.R. Bard Inc |
| 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 | REF: 123400,Bard Urologist's Tray, For the Obstructed Urethra | Cather packaging may contain the incorrect French size. | Class II | C.R. Bard 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 |
| 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 | BD Heyman Follower Straight Tip for following sizes: 10Fr - REF:21110, 1... | Cather packaging may contain the incorrect French size. | Class II | C.R. Bard Inc |
| Jun 2, 2025 | Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KN... | Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use ... | Class II | Encore Medical, LP |
| Jun 2, 2025 | Medshape Universal Joints, REF: DNE-9000-UJ | Bone external fixation system may have the pin that can become dislodged resulting in frame insta... | Class II | Medshape, INC. |
| Jun 2, 2025 | Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KN... | Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use ... | Class II | Encore Medical, LP |
| May 30, 2025 | Inseego USB8 4G Dongle Kit, Part Number: 01-2298, which contains USB Flash Dr... | Kit USB flash drive contains outdated software, which could result in reverting patient monitor t... | Class II | Remote Diagnostic Technologies Ltd. |
| May 30, 2025 | Platelia Toxo IgM Catalog Number 26211 UDI Code: 03610520005552 The Plate... | Due to a risk of false positive results that could lead to unnecessary medical treatment. | Class II | Bio-Rad Laboratories, Inc. |
| 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 29, 2025 | Achieva XR Product Numbers: (1) 781153, (2) 781253; | identified an issue where a component failure in the specific Gradient Coil type of affected syst... | Class II | Philips North America |
| May 29, 2025 | Intera 1.5T Omni/Stellar; Product Number: 781104; | identified an issue where a component failure in the specific Gradient Coil type of affected syst... | Class II | Philips North America |
| May 29, 2025 | Intera 1.5T Master/Nova Product Number: 781106; | identified an issue where a component failure in the specific Gradient Coil type of affected syst... | Class II | Philips North America |
| May 29, 2025 | Intera Achieva 1.5T Pulsar; Product Number: 781171; | identified an issue where a component failure in the specific Gradient Coil type of affected syst... | Class II | Philips North America |
| May 29, 2025 | Intera 1.5T Achieva Nova Product Number: 781172; | identified an issue where a component failure in the specific Gradient Coil type of affected syst... | Class II | Philips North America |
| May 29, 2025 | Spectral CT. Computed tomography X-ray system. | Devices with affected software may experience two unintended motion issues that may lead to conta... | Class II | Philips North America Llc |
| May 29, 2025 | Intera 1.5T Achieva Nova-Dual Product Number: 781173; | identified an issue where a component failure in the specific Gradient Coil type of affected syst... | Class II | Philips North America |
| May 29, 2025 | SmartPath to dStream for 1.5T¿; Product Number: 782146; | identified an issue where a component failure in the specific Gradient Coil type of affected syst... | Class II | Philips North America |
| May 29, 2025 | Intera 1.5T Explorer/Nova Dual Product Number: 781108; | identified an issue where a component failure in the specific Gradient Coil type of affected syst... | Class II | Philips North America |
| May 29, 2025 | Intera 1.5T Achieva IT Nova Product Number: 781175 | identified an issue where a component failure in the specific Gradient Coil type of affected syst... | Class II | Philips North America |
| May 28, 2025 | Philips S5-1 Transducer. | Ultrasound transducer devices were refurbished beyond their useful life. | Class II | Philips Ultrasound, Inc |
| May 28, 2025 | Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL ... | Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actua... | Class II | Encore Medical, LP |
| May 28, 2025 | Philips S7-2 Transducer. | Ultrasound transducer devices were refurbished beyond their useful life. | Class II | Philips Ultrasound, Inc |
| May 28, 2025 | Philips L12-3 Transducer. | Ultrasound transducer devices were refurbished beyond their useful life. | Class II | Philips Ultrasound, Inc |
| May 28, 2025 | Philips X6-1 Transducer. | Ultrasound transducer devices were refurbished beyond their useful life. | Class II | Philips Ultrasound, Inc |
| May 28, 2025 | Philips V6-2 Transducer. | Ultrasound transducer devices were refurbished beyond their useful life. | Class II | Philips Ultrasound, Inc |
| May 28, 2025 | CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Ca... | Due to an error in assembly of the thermistor within some units, the affected probes will experie... | Class II | Terumo Cardiovascular Systems Corporation |
| May 28, 2025 | Philips X8-2t Transducer. | Ultrasound transducer devices were refurbished beyond their useful life. | Class II | Philips Ultrasound, Inc |
| May 28, 2025 | Philips 3D9-3v Transducer. | Ultrasound transducer devices were refurbished beyond their useful life. | Class II | Philips Ultrasound, Inc |
| May 28, 2025 | Philips S7-3t Transducer. | Ultrasound transducer devices were refurbished beyond their useful life. | Class II | Philips Ultrasound, Inc |
| May 28, 2025 | Philips L9-3 Transducer. | Ultrasound transducer devices were refurbished beyond their useful life. | Class II | Philips Ultrasound, Inc |
| May 28, 2025 | Azurion R1.x and R2.x systems; Model Numbers: (1) 722063, (2) 722064, (3) 72... | A software issue was identified in the internal communication process between the system softwar... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| May 28, 2025 | Philips L8-4 Transducer. | Ultrasound transducer devices were refurbished beyond their useful life. | Class II | Philips Ultrasound, Inc |
| May 28, 2025 | Philips VL13-5 Transducer. | Ultrasound transducer devices were refurbished beyond their useful life. | Class II | Philips Ultrasound, Inc |
| May 28, 2025 | Philips L12-4 Transducer. | Ultrasound transducer devices were refurbished beyond their useful life. | Class II | Philips Ultrasound, Inc |
| May 28, 2025 | Philips X7-2t Transducer. | Ultrasound transducer devices were refurbished beyond their useful life. | Class II | Philips Ultrasound, Inc |
| May 28, 2025 | Philips C5-1 Transducer. | Ultrasound transducer devices were refurbished beyond their useful life. | Class II | Philips Ultrasound, Inc |
| May 28, 2025 | Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL ... | Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actua... | Class II | Encore Medical, LP |
| May 28, 2025 | Philips XL14-3 Transducer. | Ultrasound transducer devices were refurbished beyond their useful life. | Class II | Philips Ultrasound, Inc |
| May 28, 2025 | Philips S8-3t Transducer. | Ultrasound transducer devices were refurbished beyond their useful life. | Class II | Philips Ultrasound, Inc |
| May 28, 2025 | Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catal... | Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a l... | Class II | Stryker GmbH |
| May 28, 2025 | Philips X5-1 Transducer. | Ultrasound transducer devices were refurbished beyond their useful life. | Class II | Philips Ultrasound, Inc |
| May 28, 2025 | Philips C5-2 Transducer. | Ultrasound transducer devices were refurbished beyond their useful life. | Class II | Philips Ultrasound, Inc |
| May 28, 2025 | Philips eL18-4 EMT Transducer. | Ultrasound transducer devices were refurbished beyond their useful life. | Class II | Philips Ultrasound, Inc |
| May 28, 2025 | Philips eL18-4 Transducer. | Ultrasound transducer devices were refurbished beyond their useful life. | Class II | Philips Ultrasound, Inc |
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.