Browse Device Recalls
3,376 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,376 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 3,376 FDA device recalls in MA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 10, 2026 | EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner ... | Recall of kits which utilized ChloraPrep Triple Swabsticks from BD. Open or compromised seals on ... | Class II | Boston Scientific Corporation |
| Jan 27, 2026 | Impella RP. Product Code: 0046-0011. | Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to... | Class I | Abiomed, Inc. |
| Jan 27, 2026 | Impella RP with SmartAssist. Product Code: 0046-0035. | Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to... | Class I | Abiomed, Inc. |
| Jan 27, 2026 | Impella RP Flex with SmartAssist. Product Code: 1000323. | Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to... | Class I | Abiomed, Inc. |
| Jan 20, 2026 | GEM Premier 5000 PAK; Part No. 00055407504. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... | Class II | Instrumentation Laboratory |
| Jan 20, 2026 | GEM Premier 5000; Part No. 00055445010 & 00055445011. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... | Class II | Instrumentation Laboratory |
| Jan 20, 2026 | GEM Premier 5000 PAK; Part No. 00055415004. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... | Class II | Instrumentation Laboratory |
| Jan 20, 2026 | GEM Premier 5000 PAK; Part No. 00055360010. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... | Class II | Instrumentation Laboratory |
| Jan 20, 2026 | GEM Premier 5000; Part No. 00055430011. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... | Class II | Instrumentation Laboratory |
| Jan 20, 2026 | GEM Premier 5000; Part No: 00055415011. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... | Class II | Instrumentation Laboratory |
| Jan 20, 2026 | GEM Premier 5000; Part No. 00055430004. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... | Class II | Instrumentation Laboratory |
| Jan 20, 2026 | GEM Premier 5000; Part No. 00055415010. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... | Class II | Instrumentation Laboratory |
| Jan 20, 2026 | GEM Premier 5000; Part No. 00055445004. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... | Class II | Instrumentation Laboratory |
| Jan 20, 2026 | GEM Premier 5000 PAK; Part No. 00055360008. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... | Class II | Instrumentation Laboratory |
| Jan 20, 2026 | GEM Premier 5000 PAK; Part No. 00055407510. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... | Class II | Instrumentation Laboratory |
| Jan 20, 2026 | GEM Premier 5000; Part No. 00055445008. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... | Class II | Instrumentation Laboratory |
| Jan 20, 2026 | GEM Premier 5000 PAK; Part No. 00055407508. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... | Class II | Instrumentation Laboratory |
| Jan 20, 2026 | GEM Premier 5000 PAK; Part No. 00055360011. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... | Class II | Instrumentation Laboratory |
| Jan 20, 2026 | GEM Premier 5000 PAK; Part No. 00055407511. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... | Class II | Instrumentation Laboratory |
| Jan 20, 2026 | GEM Premier 5000; Part No. 00055415008. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... | Class II | Instrumentation Laboratory |
| Jan 20, 2026 | GEM Premier 5000; Part No. 00055430008. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... | Class II | Instrumentation Laboratory |
| Jan 20, 2026 | GEM Premier 5000; Model No. 00055430010. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... | Class II | Instrumentation Laboratory |
| Jan 20, 2026 | GEM Premier 5000; Part No. 00055415005. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... | Class II | Instrumentation Laboratory |
| Jan 20, 2026 | GEM Premier 5000 PAK, Part No. 00055360004. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... | Class II | Instrumentation Laboratory |
| Jan 9, 2026 | FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 5... | It was found that the contacts of the electromagnetic contactors used inside the cabinet of the X... | Class II | FUJIFILM Healthcare Americas Corporation |
| Jan 7, 2026 | Spectral CT 7500 on Rails; Product Code (REF): 728334; | As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to... | Class II | Philips North America Llc |
| Jan 7, 2026 | IQon Spectral CT; Product Code (REF): 728332; | As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to... | Class II | Philips North America Llc |
| Jan 7, 2026 | Spectral CT; Product Code (REF): 728333; | As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to... | Class II | Philips North America Llc |
| Jan 7, 2026 | Brilliance iCT; Product Code (REF): 728306; | As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to... | Class II | Philips North America Llc |
| Jan 6, 2026 | WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM | The mix up of the impression caps provided in the package. The provided impression caps are magen... | Class III | Straumann USA LLC |
| Dec 31, 2025 | Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit. | A systematic positive bias of up to 20% was identified across the reportable potassium range, res... | Class II | Medica Corporation |
| Dec 31, 2025 | BEAR Implant. Model Number: 1000. | Incorrect expiration date on label that extends beyond the product's documented/approved shelf li... | Class II | Miach Orthopaedics |
| Dec 22, 2025 | Patient Information Center iX; Software Version Number: 4.5.0 | A recent software (SW) patch modifies Mobile Event Notification filter settings without providing... | Class II | Philips North America |
| Dec 19, 2025 | AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm; Materia... | Increased reports of stent deployment and expansion issues. The most common outcome reasonably fo... | Class I | Boston Scientific Corporation |
| Dec 19, 2025 | *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm; Ma... | Increased reports of stent deployment and expansion issues. The most common outcome reasonably fo... | Class I | Boston Scientific Corporation |
| Dec 19, 2025 | AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Materia... | Increased reports of stent deployment and expansion issues. The most common outcome reasonably fo... | Class I | Boston Scientific Corporation |
| Dec 19, 2025 | *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; ... | Increased reports of stent deployment and expansion issues. The most common outcome reasonably fo... | Class I | Boston Scientific Corporation |
| Dec 19, 2025 | AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Mater... | Increased reports of stent deployment and expansion issues. The most common outcome reasonably fo... | Class I | Boston Scientific Corporation |
| Dec 19, 2025 | HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Mat... | Increased reports of stent deployment and expansion issues. The most common outcome reasonably fo... | Class I | Boston Scientific Corporation |
| Dec 15, 2025 | Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument. | Presence of particulates in affected devices that can be deposited into breast tissue during use. | Class II | Hologic, Inc |
| Dec 12, 2025 | Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor. | It was found that the MX40 device could not reconnect to the PIC iX when moving between Radiohead... | Class II | Philips North America Llc |
| Dec 12, 2025 | ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution. | Fungal contamination of affected lot with Parengyodontium album. | Class II | Hologic, Inc |
| Dec 11, 2025 | The product is used for the evaluation of the intrinsic coagulation pathway, ... | Potential for microbial contamination. | Class II | Instrumentation Laboratory |
| Dec 10, 2025 | MAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of a ... | Potential Elevated Laser Output A disconnected cable or a poorly crimped cable under mechanical b... | Class II | REPLIGEN CORPORATION |
| Dec 5, 2025 | BVI Leos Laser and Endoscopy System. Model Number: OME6000U. | Manufacturing deviation in which the ferrites specified for the USB cable assembly linking the Nu... | Class II | Beaver-Visitec International, Inc. |
| Dec 4, 2025 | Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU. | Device packaged in incorrect outer box carton. | Class II | Abiomed, Inc. |
| Dec 4, 2025 | Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (C... | AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label. | Class II | Mobius Imaging, LLC |
| Dec 4, 2025 | Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (C... | AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label. | Class II | Mobius Imaging, LLC |
| Dec 3, 2025 | Ingenia 1.5T. Product Code (REF): (1) 781341, (2) 781396. MR systems with... | The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness ma... | Class II | Philips North America |
| Dec 3, 2025 | Upgrade to MR 7700. Product Code (REF): 782130. MR systems with SW versio... | The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness ma... | Class II | Philips North America |
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.