Browse Device Recalls
3,505 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,505 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 3,505 FDA device recalls in MA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 13, 2021 | Covidien Parietex hydrophilic anatomical mesh 15 cm x 10 cm polyester left - ... | incorrect device is contained in the package. The packaging label indicates that the device is fo... | Class II | Covidien Llc |
| Jan 12, 2021 | Grasper/Retriever, Alligator Jaw 2.4 mm x 5 mm x 230 cm Catalog Number: 7208 ... | Mislabeled: Devices labeled as catalog #7208 (Grasper/Retriever, Alligator Jaw, 2.4 mm x 5 mm x 2... | Class II | Shent USA, Inc. |
| Jan 12, 2021 | Grasper/Retriever, Alligator Jaw, Rat Tooth 2.4 mm x 8 mm x 230 cm Catalog ... | Mislabeled: Devices labeled as catalog #7208 (Grasper/Retriever, Alligator Jaw, 2.4 mm x 5 mm x 2... | Class II | Shent USA, Inc. |
| Jan 11, 2021 | LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA (48 Tests / EN). LumiraDx Sever... | Observations of potential false positive results in the specified lots. Use of these test strips ... | Class II | LumiraDx |
| Dec 24, 2020 | PHILIPS Incisive Computed tomography X-ray system Incisive CT Software Upgra... | Patient tabletop moved out to the home position during scan initialization, may cause operator/by... | Class II | Philips North America |
| Dec 23, 2020 | Infinity Acute Care System (IACS) Monitoring Solution: The IACS is intended ... | The Infinity M540 patient monitor may randomly reboot due to an error to correctly transmit and r... | Class II | Draegar Medical Systems, Inc. |
| Dec 22, 2020 | Wako HDL-C/LDL-C Calibrator - Product Usage: designed to be used with Wako L-... | FUJIFILM has become aware that incorrect concentration values were printed on the bottle label fo... | Class III | Fujifilm Medical Systems U.S.A., Inc. |
| Dec 21, 2020 | SERF Novae Dual Mobility Cup Insert 47/28- ApeX-LNK Poly Liner. Intended for ... | Acetabular Liners have a higher than acceptable oxidation limit, potential for patients to experi... | Class II | OMNIlife science Inc. |
| Dec 21, 2020 | SERF Novae Dual Mobility Cup Insert 51/28- ApeX-LNK Poly Liner. Intended for ... | Acetabular Liners have a higher than acceptable oxidation limit, potential for patients to experi... | Class II | OMNIlife science Inc. |
| Dec 21, 2020 | SERF Novae Dual Mobility Cup Insert 49/28-ApeX-LNK Poly Liner. Intended for u... | Acetabular Liners have a higher than acceptable oxidation limit, potential for patients to experi... | Class II | OMNIlife science Inc. |
| Dec 17, 2020 | Fresenius Medical Care NaturaLyte Liquid Acid concentrate-Liquid Acid Concent... | Bottles Missing Product Label | Class II | Fresenius Medical Care Holdings, Inc. |
| Dec 11, 2020 | FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 - Product Usage: in... | The software does not update measurements and calculations in the Clinical Reporting Application ... | Class II | Fujifilm Medical Systems U.S.A., Inc. |
| Dec 8, 2020 | ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system | After the user selects the Lock-in command, the kV and mA values are not locked immediately and c... | Class II | PHILIPS HOME HEALTHCARE SOLUTION |
| Dec 1, 2020 | AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm UPN: M00... | The rotating luer fitting at the distal end of the delivery system handle may become detached fr... | Class II | Boston Scientific Corporation |
| Dec 1, 2020 | Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm (OUS... | The rotating luer fitting at the distal end of the delivery system handle may become detached fr... | Class II | Boston Scientific Corporation |
| Dec 1, 2020 | AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm UPN: M00... | The rotating luer fitting at the distal end of the delivery system handle may become detached fr... | Class II | Boston Scientific Corporation |
| Dec 1, 2020 | Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm (OUS... | The rotating luer fitting at the distal end of the delivery system handle may become detached fr... | Class II | Boston Scientific Corporation |
| Dec 1, 2020 | AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm UPN: M00... | The rotating luer fitting at the distal end of the delivery system handle may become detached fr... | Class II | Boston Scientific Corporation |
| Dec 1, 2020 | Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm (OUS... | The rotating luer fitting at the distal end of the delivery system handle may become detached fr... | Class II | Boston Scientific Corporation |
| Nov 23, 2020 | Naturalyte Liquid Acid concentrate bottles, Product Code 08-2301-3 - Product ... | The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity... | Class II | Fresenius Medical Care Holdings, Inc. |
| Nov 23, 2020 | Naturalyte Liquid Acid concentrate drums, Product Code 13-3251-9 - Product Us... | The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity... | Class II | Fresenius Medical Care Holdings, Inc. |
| Nov 23, 2020 | Naturalyte Liquid Acid concentrate bottles, Product Code 08-1251-1 - Product ... | The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity... | Class II | Fresenius Medical Care Holdings, Inc. |
| Nov 23, 2020 | Naturalyte Liquid Acid concentrate bottles, Product Code 08-3251-9 - Product ... | The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity... | Class II | Fresenius Medical Care Holdings, Inc. |
| Nov 23, 2020 | Citrasate Liquid Acid concentrate drums, Product Code 13-2251 -CA - Product U... | The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity... | Class II | Fresenius Medical Care Holdings, Inc. |
| Nov 23, 2020 | Naturalyte Liquid Acid concentrate bottles, Product Code 08-2251-0 - Product ... | The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity... | Class II | Fresenius Medical Care Holdings, Inc. |
| Nov 23, 2020 | Covidien TA Auto Suture Vascular Stapler with DST Series Technology 30mm-V 3... | May contain a damaged internal component which could impede staple deployment and result in incom... | Class II | Covidien Llc |
| Nov 23, 2020 | Naturalyte Liquid Acid concentrate drums, Product Code 13-2251-0 - Product Us... | The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity... | Class II | Fresenius Medical Care Holdings, Inc. |
| Nov 23, 2020 | Citrasate Liquid Acid concentrate bottles, Product Code 08-2251-CA - Product ... | The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity... | Class II | Fresenius Medical Care Holdings, Inc. |
| Nov 23, 2020 | Naturalyte Liquid Acid concentrate bottles, Product Code 08-4231-0 - Product ... | The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity... | Class II | Fresenius Medical Care Holdings, Inc. |
| Nov 23, 2020 | Covidien TA Auto Suture Vascular Loading Unit with DST Series Technology 30 m... | May contain a damaged internal component which could impede staple deployment and result in incom... | Class II | Covidien Llc |
| Nov 23, 2020 | Naturalyte Liquid Acid concentrate bottles, Product Code 08-2351-8 - Product ... | The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity... | Class II | Fresenius Medical Care Holdings, Inc. |
| Nov 23, 2020 | Naturalyte Liquid Acid concentrate bottles, Product Code 08-2201-5 - Product ... | The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity... | Class II | Fresenius Medical Care Holdings, Inc. |
| Nov 19, 2020 | Emission Computed Tomography System Image Process System - Product Usage: int... | A software defect that has the potential to result in image misdiagnosis and incorrect treatment ... | Class II | Philips North America, LLC |
| Nov 18, 2020 | Philips IntelliVue X2 Multi measurement Server: M3002A (865039) - Product Usa... | Speakers on IntelliVue X2 and IntelliVue MP2 may fail, identified by the display of a Speaker M... | Class II | Philips North America Llc |
| Nov 18, 2020 | Philips IntelliVue MP2 Patient Monitors (865040) - Product Usage: intended fo... | Speakers on IntelliVue X2 and IntelliVue MP2 may fail, identified by the display of a Speaker M... | Class II | Philips North America Llc |
| Nov 16, 2020 | Contour VL Variable Length Ureteral Stent, UPN M0061801550, M0061801560, M006... | Trace amounts of metallic debris were found on the stent related to the manufacturing process. Th... | Class II | Boston Scientific Corporation |
| Nov 16, 2020 | Capnostream 35 Portable Respiratory Monitor, Product numbers PM35MN02, PM35MN... | The firm has released software update V01.05.02.16 (also known as V1.5.2) in response to customer... | Class II | Covidien Llc |
| Nov 16, 2020 | Contour VL Variable Length Ureteral Stent Set, UPN M006180155090, M0061801560... | Trace amounts of metallic debris were found on the stent related to the manufacturing process. Th... | Class II | Boston Scientific Corporation |
| Nov 7, 2020 | NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2251-0 - Product ... | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. | Class II | Fresenius Medical Care Holdings, Inc. |
| Nov 7, 2020 | NaturaLyte Liquid Acid concentrate drums, Model Number 13-3251-9 - Product Us... | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. | Class II | Fresenius Medical Care Holdings, Inc. |
| Nov 7, 2020 | Citrasate Liquid Acid concentrate drums, Model Number 13-2251-CA - Product Us... | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. | Class II | Fresenius Medical Care Holdings, Inc. |
| Nov 7, 2020 | Citrasate Liquid Acid concentrate drums, Model Number 13-3251-CA - Product Us... | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. | Class II | Fresenius Medical Care Holdings, Inc. |
| Nov 7, 2020 | NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3301-2 - Product ... | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. | Class II | Fresenius Medical Care Holdings, Inc. |
| Nov 7, 2020 | NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3201-4 - Product ... | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. | Class II | Fresenius Medical Care Holdings, Inc. |
| Nov 7, 2020 | NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3231-1 - Product ... | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. | Class II | Fresenius Medical Care Holdings, Inc. |
| Nov 7, 2020 | NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2301-3 - Product ... | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. | Class II | Fresenius Medical Care Holdings, Inc. |
| Nov 7, 2020 | NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2231-2 - Product ... | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. | Class II | Fresenius Medical Care Holdings, Inc. |
| Nov 7, 2020 | NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3251-9 - Product ... | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. | Class II | Fresenius Medical Care Holdings, Inc. |
| Nov 7, 2020 | NaturaLyte Liquid Acid concentrate bottles, Model Number 08-1251-1 - Product ... | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. | Class II | Fresenius Medical Care Holdings, Inc. |
| Nov 7, 2020 | Citrasate Liquid Acid concentrate bottles, Model Number 08-3251-CA - Product ... | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. | Class II | Fresenius Medical Care Holdings, 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.