Browse Device Recalls
3,378 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,378 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 3,378 FDA device recalls in MA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Feb 25, 2025 | Zenition 50. Product Code 718096. The devices are used for radiological guid... | A wireless foot switch pedal may get stuck in the active position when the user releases the peda... | Class II | Philips North America Llc |
| Feb 25, 2025 | Veradius Unity. Product Code 718132. The devices are used for radiological gu... | A wireless foot switch pedal may get stuck in the active position when the user releases the peda... | Class II | Philips North America Llc |
| Feb 25, 2025 | Zenition 70. Product Code 718133. The devices are used for radiological guida... | A wireless foot switch pedal may get stuck in the active position when the user releases the peda... | Class II | Philips North America Llc |
| Feb 24, 2025 | COR Disposable Kit, 8 mm w/ Perpendicularity. Cartilage Transplant System. | Device is missing the pin in the graft loader component. | Class II | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| Feb 24, 2025 | COR Disposable Kit, 8 mm. Cartilage Transplant System. | Device is missing the pin in the graft loader component. | Class II | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| Feb 13, 2025 | Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-... | The potential for devices to fail their self-test as a result of prolonged exposure to extreme en... | Class II | ZOLL Medical Corporation |
| Feb 13, 2025 | Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) ... | The potential for devices to fail their self-test as a result of prolonged exposure to extreme en... | Class II | ZOLL Medical Corporation |
| Feb 13, 2025 | Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) ... | The potential for devices to fail their self-test as a result of prolonged exposure to extreme en... | Class II | ZOLL Medical Corporation |
| Feb 13, 2025 | Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-... | The potential for devices to fail their self-test as a result of prolonged exposure to extreme en... | Class II | ZOLL Medical Corporation |
| Feb 13, 2025 | Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) ... | The potential for devices to fail their self-test as a result of prolonged exposure to extreme en... | Class II | ZOLL Medical Corporation |
| Feb 13, 2025 | Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) ... | The potential for devices to fail their self-test as a result of prolonged exposure to extreme en... | Class II | ZOLL Medical Corporation |
| Feb 13, 2025 | Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) ... | The potential for devices to fail their self-test as a result of prolonged exposure to extreme en... | Class II | ZOLL Medical Corporation |
| Feb 13, 2025 | Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) ... | The potential for devices to fail their self-test as a result of prolonged exposure to extreme en... | Class II | ZOLL Medical Corporation |
| Feb 11, 2025 | Synapse PACS Software Version 7.4.x; Software Versions: 7.4.000, 7.4.001, 7.4... | The incorrect computed patient age is showing in VX for patients less than 3 months old. | Class II | FUJIFILM Healthcare Americas Corporation |
| Feb 7, 2025 | CardiFocus Heartlight X3 Catheter- Intended in the treatment of atrial fibril... | Damage to the sterile barrier pouch of catheter, which could potentially compromise its sterility. | Class II | CardioFocus, 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.