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.

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DateProductReasonClassFirm
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.