Browse Device Recalls
35,653 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,653 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 35,653 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 19, 2025 | PRIMA 2MM ECCENTRICAL ADAPTOR WITH SCREW REF: 1367.15.702, Sterile | There is the potential that the eccentrical adaptor with screw, black laser marking, use to ident... | Class II | Limacorporate S.p.A |
| 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 | GE Healthcare Versana Ultrasound Systems, sold under the following names and ... | GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on ... | Class II | GE Medical Systems China Co., Ltd. |
| May 16, 2025 | Brand Name: Q-Stop Product Name: Suture Retention Device Model/Catalog Number... | XXX | Class II | Drs Vascular, Inc |
| May 16, 2025 | GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, dia... | GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on ... | Class II | GE Medical Systems China Co., Ltd. |
| May 16, 2025 | Brand Name: Cellex Photopheresis System Product Name: CELLEX Photopheresis K... | Increased difficulty in installing the centrifuge bowl onto the centrifuge bowl holder. Improper ... | Class II | THERAKOS DEVELOPMENT LIMITED |
| May 15, 2025 | ARTIS is a family of dedicated angiography systems developed for single and ... | In very rare situations, communication between the sensor measuring dose applied to the area and ... | Class II | Siemens Medical Solutions USA, Inc |
| May 15, 2025 | interventional fluoroscopic x-ray system | In very rare situations, communication between the sensor measuring dose applied to the area and ... | Class II | Siemens Medical Solutions USA, Inc |
| May 15, 2025 | interventional fluoroscopic x-ray system | In very rare situations, communication between the sensor measuring dose applied to the area and ... | Class II | Siemens Medical Solutions USA, Inc |
| May 15, 2025 | interventional fluoroscopic x-ray system | In very rare situations, communication between the sensor measuring dose applied to the area and ... | Class II | Siemens Medical Solutions USA, Inc |
| May 15, 2025 | Contamac, Nutrifill Physiologic formula, Contact Lens Insertion solution | Contact lens insertion solution may lack sterility. | Class II | Contamac Solutions, Inc. |
| May 15, 2025 | Medline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250 | There is a possible packaging defect impacting the outer Tyvec pouch that protects the sterile pr... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 13, 2025 | SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves w... | Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause del... | Class II | Cardinal Health 200, LLC |
| May 13, 2025 | Ami HTX. | The X-ray safety and manufacturing date labels affixed to the Lago X/ AMI HTX instrument do not c... | Class II | Spectral Instruments Inc |
| May 13, 2025 | Product Name: MR 7700; Model Numbers: (1) 782120, (2) 782153; | Potential for alignment errors in the cross reference line functionality when reviewing images ge... | Class II | Philips North America Llc |
| May 13, 2025 | Product Name: Ingenia 1.5T CX; Model Number: 781262; | Potential for alignment errors in the cross reference line functionality when reviewing images ge... | Class II | Philips North America Llc |
| May 13, 2025 | Allon 2001. Part Number: 200-00263 | An investigation into a report of the patient wrap (ThermoWrap), used with the Allon device, exce... | Class II | Belmont Instrument LLC |
| May 13, 2025 | Product Name: Evolution Upgrade 1.5T; Model Numbers: (1) 782116, (2) 782148; | Potential for alignment errors in the cross reference line functionality when reviewing images ge... | Class II | Philips North America Llc |
| May 13, 2025 | Product Name: SmartPath to dStream for XR and 3.0T; Model Numbers: (1) 78127... | Potential for alignment errors in the cross reference line functionality when reviewing images ge... | Class II | Philips North America Llc |
| May 13, 2025 | Product Name: SmartPath to dStream for 1.5T; Model Numbers: (1) 781260, (2) ... | Potential for alignment errors in the cross reference line functionality when reviewing images ge... | Class II | Philips North America Llc |
| May 13, 2025 | Product Name: MR 5300; Model Numbers: (1) 782110, (2) 782152; | Potential for alignment errors in the cross reference line functionality when reviewing images ge... | Class II | Philips North America Llc |
| May 13, 2025 | Product Name: Ingenia 1.5T; Model Numbers: (1) 781315, (2) 781341, (3) 78139... | Potential for alignment errors in the cross reference line functionality when reviewing images ge... | Class II | Philips North America Llc |
| May 13, 2025 | Product Name: Upgrade to MR 7700; Model Number: 782130; | Potential for alignment errors in the cross reference line functionality when reviewing images ge... | Class II | Philips North America Llc |
| May 13, 2025 | Kendall SCD Blended Comfort Sleeves Knee Length Small - For use with Kendal... | Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause del... | Class II | Cardinal Health 200, LLC |
| May 13, 2025 | Product Name: Ingenia Ambition S; Model Numbers: (1) 781359, (2) 782108, (3)... | Potential for alignment errors in the cross reference line functionality when reviewing images ge... | Class II | Philips North America Llc |
| May 13, 2025 | Kendall SCD Comfort Sleeves Knee Length Small, Pediatric - For use with Ken... | Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause del... | Class II | Cardinal Health 200, LLC |
| May 13, 2025 | Product Name: Ingenia Elition X; Model Numbers: (1) 781358, (2) 782107, (3) ... | Potential for alignment errors in the cross reference line functionality when reviewing images ge... | Class II | Philips North America Llc |
| May 13, 2025 | Product Name: Ingenia 3.0T; Model Numbers: (1) 781342, (2) 781377, (3) 782103; | Potential for alignment errors in the cross reference line functionality when reviewing images ge... | Class II | Philips North America Llc |
| May 13, 2025 | Product Name: Ingenia 1.5T S; Model Number: 781347; | Potential for alignment errors in the cross reference line functionality when reviewing images ge... | Class II | Philips North America Llc |
| May 13, 2025 | Product Name: SmartPath to dStream for 3.0T; Model Number: 782145 | Potential for alignment errors in the cross reference line functionality when reviewing images ge... | Class II | Philips North America Llc |
| May 13, 2025 | Product Name: Ingenia Ambition X; Model Numbers: (1) 781356, (2) 782109, (3)... | Potential for alignment errors in the cross reference line functionality when reviewing images ge... | Class II | Philips North America Llc |
| May 13, 2025 | Product Name: Ingenia Elition S; Model Numbers: (1) 781357, (2) 782106, (3) ... | Potential for alignment errors in the cross reference line functionality when reviewing images ge... | Class II | Philips North America Llc |
| May 13, 2025 | Lago X | The X-ray safety and manufacturing date labels affixed to the Lago X/ AMI HTX instrument do not c... | Class II | Spectral Instruments Inc |
| May 13, 2025 | Product Name: SmartPath to Ingenia Elition X; Model Numbers: (1) 782118, (2)... | Potential for alignment errors in the cross reference line functionality when reviewing images ge... | Class II | Philips North America Llc |
| May 13, 2025 | Product Name: Evolution Upgrade 3.0T; Model Numbers: (1) 782117, (2) 782143; | Potential for alignment errors in the cross reference line functionality when reviewing images ge... | Class II | Philips North America Llc |
| May 13, 2025 | Product Name: Ingenia 3.0T CX; Model Number: 781271; | Potential for alignment errors in the cross reference line functionality when reviewing images ge... | Class II | Philips North America Llc |
| May 12, 2025 | BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241-0500 | Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded... | Class II | BD SWITZERLAND SARL |
| May 12, 2025 | BD Texium: 3 mL, REF: MY8003-0006; 5 mL, REF: MY8005-0006; 10 mL, REF: MY8010... | Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded... | Class II | BD SWITZERLAND SARL |
| May 12, 2025 | da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15 | Robotic-assisted surgical system arm drapes may detach from the instrument arm due to an issue in... | Class II | Intuitive Surgical, Inc. |
| May 12, 2025 | Baxter Novum IQ Syringe Pump, product code 40800BAXUS, | Baxter has identified a design issue which may cause the pump to detect the presence of a syringe... | Class II | Baxter Healthcare Corporation |
| May 12, 2025 | The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue G... | Glucose microcuvettes experienced transit time outside of limits, so stability through the whole ... | Class II | HemoCue AB |
| May 12, 2025 | BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241; BD TEXIUM (China)... | Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded... | Class II | BD SWITZERLAND SARL |
| May 12, 2025 | BD Texium Needle-Free Syringe: 3 mL, REF: MY8003; 5 mL, REF: MY8005; 10 mL, R... | Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded... | Class II | BD SWITZERLAND SARL |
| May 12, 2025 | Alaris Pump Infusion Set: SmartSite Bag Access Non-Vented Bonded Texium With... | Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded... | Class II | BD SWITZERLAND SARL |
| May 9, 2025 | Brand Name: VITROS Product Name: VITROS 4600 Chemistry System Model/Catalog... | a software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent pa... | Class II | Ortho-Clinical Diagnostics, Inc. |
| May 9, 2025 | Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalo... | A software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent pa... | Class II | Ortho-Clinical Diagnostics, Inc. |
| May 9, 2025 | Model: Description/REF: MNA-420: MNA-420 ENC -H/K9303320, MNA-420 DEC -H V2/K... | Cathode ray tube display system encoders and decoders have same MAC address; new system setup wit... | Class II | Barco N.V. |
| May 9, 2025 | Brand Name: VITROS; Product Name: VITROS XT 7600 Integrated System; Model/C... | a software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent pa... | Class II | Ortho-Clinical Diagnostics, Inc. |
| May 9, 2025 | 2.5 V replacement rechargeable batteries for Hillrom WELCH ALLYN PocketScope ... | The replacement rechargeable batteries inserted into the Welch Allyn PocketScope handles have the... | Class II | Baxter Healthcare Corporation |
| 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. |
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.