Browse Device Recalls
3,494 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,494 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 3,494 FDA device recalls in MA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Apr 23, 2025 | MAHURKAR Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter. | Potential breach of sterile barrier packaging. | Class II | Mozarc Medical US LLC |
| Apr 23, 2025 | Palindrome Precision SI Chronic Hemodialysis Catheter Sport Pack. Radiopaque ... | Potential breach of sterile barrier packaging. | Class II | Mozarc Medical US LLC |
| Apr 23, 2025 | Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Pack. Radiopaque... | Potential breach of sterile barrier packaging. | Class II | Mozarc Medical US LLC |
| Apr 23, 2025 | Palindrome Precision Chronic Hemodialysis Catheter Sport Pack. Radiopaque ure... | Potential breach of sterile barrier packaging. | Class II | Mozarc Medical US LLC |
| Apr 17, 2025 | WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments. | Incorrect blister labelling. | Class II | Straumann USA LLC |
| Apr 15, 2025 | ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376. | Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator do not meet ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Apr 15, 2025 | Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498 | Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator do not meet ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Apr 14, 2025 | Plus Initial Drill, Article Number: 103.170; | The referred batch was produced without the laser engraving of 7 mm. | Class II | Straumann USA LLC |
| Apr 11, 2025 | Pruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09, E2102-09. | During internal product testing, it was observed that some packages to have incomplete seals (ste... | Class II | LeMaitre Vascular, Inc. |
| Apr 11, 2025 | TufTex Over-the-Wire Embolectomy Catheter. All Catalog numbers: 1651-34, 1651... | During internal product testing, it was observed that some packages to have incomplete seals (ste... | Class II | LeMaitre Vascular, Inc. |
| Apr 11, 2025 | Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-... | During internal product testing, it was observed that some packages to have incomplete seals (ste... | Class II | LeMaitre Vascular, Inc. |
| Apr 9, 2025 | FoundationOne Companion Diagnostic (F1CDx) | Four (4) total reports were sent to customers with clinically relevant variants requiring amendme... | Class II | Foundation Medicine, Inc. |
| Apr 7, 2025 | Microstream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as Adt... | Disconnection of the adapter from the endotracheal tube can potentially be difficult or not possi... | Class II | Philips North America Llc |
| Apr 1, 2025 | Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomogr... | Unintended motion issues related to Interventional Control that may lead to collision of the Gant... | Class II | Philips North America Llc |
| Mar 31, 2025 | Straight Inflow/Bifurcated Outflow Line Kit. Model Number: 902-00038. St... | Potential crack in the female connector located on the Heat Exchanger in the set, which will lead... | Class II | Belmont Instrument LLC |
| Mar 31, 2025 | Straight Inflow/Outflow Patient Line Kit. Model Number: 902-00037. Steri... | Potential crack in the female connector located on the Heat Exchanger in the set, which will lead... | Class II | Belmont Instrument LLC |
| Mar 31, 2025 | Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparin... | Siemens Healthcare Diagnostics Inc., is recalling their Stratus CS Acute Care cTNI TestPak, an IV... | Class II | Siemens Healthcare Diagnostics Inc |
| Mar 31, 2025 | Hyperthermia Pump Procedure Kit. Model Number: 902-00045. Sterile, singl... | Potential crack in the female connector located on the Heat Exchanger in the set, which will lead... | Class II | Belmont Instrument LLC |
| Mar 31, 2025 | 3.0 Liter Disposable Set (4 sets/case). Model Number: 903-00032. The P/... | Potential crack in the female connector located on the Heat Exchanger/patient line set, which wil... | Class II | Belmont Instrument LLC |
| Mar 25, 2025 | restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: H... | The hip cup liner that was packaged with the incorrect labeling. HDL-060-C22S-000101 from Lot 178... | Class II | Conformis Inc. |
| Mar 19, 2025 | epoc BGEM Crea Test Card (25 pk) for the epoc Blood Analysis System; Siemens ... | The occurrence of discrepant high pH results in samples introduced with higher injection volumes ... | Class II | Siemens Healthcare Diagnostics Inc |
| Mar 19, 2025 | epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens M... | The occurrence of discrepant high pH results in samples introduced with higher injection volumes ... | Class II | Siemens Healthcare Diagnostics Inc |
| Mar 10, 2025 | Philips DXR System, DuraDiagnost 4.1. Stationary X-Ray System. | Potential for collimator to fall as a result of incorrect installation. | Class II | Philips North America Llc |
| Mar 10, 2025 | Philips DXR System, DuraDiagnost Rel. 4. Stationary X-Ray System. | Potential for collimator to fall as a result of incorrect installation. | Class II | Philips North America Llc |
| Mar 8, 2025 | TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002; | The devices are missing the laser marked depth markings. | Class II | Straumann USA 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.