Browse Device Recalls
3,419 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,419 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 3,419 FDA device recalls in MA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 26, 2025 | RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097. | Siemens Healthcare Diagnostics is recalling the RAPIDPoint 500 Systems Wash/Waste Cartridge Lot W... | Class II | Siemens Healthcare Diagnostics Inc |
| Jun 24, 2025 | LVP Blood Products Administration Set Dual-Inlet, Low-Sorbing, Y-Site, Mesh F... | Potential for external cassette leaks | Class II | Fresenius Kabi USA, LLC |
| Jun 24, 2025 | LVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25). Product C... | Potential for external cassette leaks | Class II | Fresenius Kabi USA, LLC |
| Jun 24, 2025 | LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-... | Potential for external cassette leaks | Class II | Fresenius Kabi USA, LLC |
| Jun 24, 2025 | LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Du... | Potential for external cassette leaks | Class II | Fresenius Kabi USA, LLC |
| Jun 23, 2025 | Automated Impella Controller (AIC), used in left heart support blood pump, in... | A potential issue with the Automated Impella Controller (AIC) not detecting an Impella pump when ... | Class I | Abiomed, Inc. |
| Jun 11, 2025 | ASPRIRE Cristalle Mammography System (cleared under K212873) installed with t... | Devices had an unapproved slabbing software function enabled for use. | Class II | FUJIFILM Healthcare Americas Corporation |
| Jun 10, 2025 | BostonSight PROSE Lens. | Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both. | Class II | Boston Foundation For Sight |
| Jun 10, 2025 | BostonSight SCLERAL Lens | Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both. | Class II | Boston Foundation For Sight |
| 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 | 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 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 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 | 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 27, 2025 | O-arm O2 Imaging System. Mobile X-Ray System. | A mechanical component that supports the O2 gantry to the support structure in affected devices m... | Class II | Medtronic Navigation, Inc.-Boxborough |
| May 23, 2025 | Omnipod 5 Automated Insulin Delivery System, iOS Application. Model Number: P... | Insulet Corporation is recalling Omnipod 5 iOS App, due to a software design issue in which a com... | Class II | Insulet Corporation |
| 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 | 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: 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: 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: 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: 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 | 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: 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 | 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: 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 | 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: 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 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: 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 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: 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 | 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 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 12, 2025 | IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low... | Mis-assembly error of Blood Products Administrations Sets where the 200-micron drip chamber filte... | Class I | Fresenius Kabi USA, LLC |
| May 7, 2025 | Z-800F Infusion System. Intended to provide intravenous infusion of parentera... | Unreleased software versions were installed on distributed devices without verification or valida... | Class I | Zyno Medical LLC |
| May 7, 2025 | Z-800W Infusion System. Intended to provide intravenous infusion of parentera... | Unreleased software versions were installed on distributed devices without verification or valida... | Class I | Zyno Medical LLC |
| May 7, 2025 | Z-800WF Infusion System. Intended to provide intravenous infusion of parenter... | Unreleased software versions were installed on distributed devices without verification or valida... | Class I | Zyno Medical LLC |
| May 7, 2025 | Z-800 Infusion System. Intended to provide intravenous infusion of parenteral... | Unreleased software versions were installed on distributed devices without verification or valida... | Class I | Zyno Medical LLC |
| May 1, 2025 | GM Helix Acqua Implant, Article Number: 140.985 | It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead. | Class II | Straumann USA LLC |
| May 1, 2025 | GM Helix Acqua Implant, Article Number: 140.984 | It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead. | Class II | Straumann USA LLC |
| Apr 29, 2025 | 5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the followin... | Potential of blood leak occurring between the lower port of the venous chamber and the tubing inc... | Class II | Fresenius Medical Care Holdings, Inc. |
| Apr 28, 2025 | NxStage PureFlow-B Solution. Catalog numbers: RFP-400, RFP-401, RFP-402, RFP-... | Potential for the perimeter seal on the small chamber of the two-chamber bag to fail causing the ... | Class II | NxStage Medical Inc |
| Apr 23, 2025 | Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack. Radiopaque u... | Potential breach of sterile barrier packaging. | Class II | Mozarc Medical US 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.