Browse Device Recalls

35,290 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 35,290 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 35,290 FDA device recalls, Class II.

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DateProductReasonClassFirm
Mar 14, 2024 Non-sterile convenience kits: Medline Open Heart CDS, Pack #CDS981759C, co... Surgical convenience kits containing Pure Pouch component that has weak seals which may result in... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 14, 2024 Sterile surgical convenience kits: a. Medline Cath Lab Special Procedure,... Surgical convenience kits containing Pure Pouch component that has weak seals which may result in... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 14, 2024 Nonsterile convenience kits: a. Medline Delivery, Pack #DYNJ901130I, cont... Surgical convenience kits containing Pure Pouch component that has weak seals which may result in... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 14, 2024 Sterile convenience kit: Medline Birthing Room Pack, Pack #DYNJ38429D, con... Surgical convenience kits containing Pure Pouch component that has weak seals which may result in... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 14, 2024 Sterile surgical convenience kit: Medline Retrograde PK-22025203-LF, Pack ... Surgical convenience kits containing Pure Pouch component that has weak seals which may result in... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 13, 2024 Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, M... Surgical system may have inadequately welded top and/or bottom belts in the link 2 of the entry g... Class II Intuitive Surgical, Inc.
Mar 13, 2024 Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Numbe... Received complaints that bottles assembled with one batch of bottle collars can be disassembled i... Class II Electro Medical Systems SA
Mar 13, 2024 Atellica CH Iron3 - IVD use in the quantitative measurement of iron in human ... Potential for falsely elevated Chol_2, LDLC, and Trig_2 results on the Atellica CH and Atellica C... Class II Siemens Healthcare Diagnostics, Inc.
Mar 13, 2024 Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Numb... Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing pro... Class II Biomet, Inc.
Mar 13, 2024 Brand Name: WATER BOTTLE Product Name: WATER BOTTLE Model/Catalog Number: E... Received complaints that bottles assembled with one batch of bottle collars can be disassembled i... Class II Electro Medical Systems SA
Mar 13, 2024 Brand Name: PIEZON Bottle Product Name: PIEZON Bottle Model/Catalog Number:... Received complaints that bottles assembled with one batch of bottle collars can be disassembled i... Class II Electro Medical Systems SA
Mar 12, 2024 Ingenia 1.5T S, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Achieva 1.5T, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Intera 1.5T Omni/Stellar, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Achieva 3.0T, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 GYROSCAN T5-NT, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Intera 1.5T, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Namic FLUID DELIVERY SET, REF 91300040 Products have a lack of sterility assurance. Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 12, 2024 Intera 1.5T Achieva Nova, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Intera 1.5T Achieva IT Nova, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Intera 1.0T Omni/Stellar, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 GYROSCAN ACS-NT, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Achieva XR, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Intera 1.5T Achieva Nova-Dual, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Ingenia 1.5T CX, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 namic CONVENIENCE KIT, a) CAROTID MANIFOLD KIT, REF 60011045; b) 3V MANIF... Products have a lack of sterility assurance. Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 12, 2024 Ingenia Elition S, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Intera 1.5T Explorer/Nova Dual, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 SmartPath to dStream for 1.5T, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Achieva 3.0T for PET, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 MR 5300, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Ingenia Ambition X, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Intera 1.5T Power/Pulsar, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Co... Product incorrectly labelled. Class II DePuy Orthopaedics, Inc.
Mar 12, 2024 Intera 0.5T Standard, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 SmartPath to dStream for XR and 3.0T, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Ingenia 1.5T, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 GYROSCAN T10-NT, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Intera 3.0T Quasar Dual, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Ingenia 3.0T, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Ingenia Ambition S, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Intera 1.5T Master/Nova, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Ingenia 3.0T CX, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Ingenia Elition X, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Enterprise 1.5T, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 MR 7700, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 GYROSCAN T5, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Intera Achieva 1.5T Pulsar, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Achieva 3.0TX for PET, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Intera CV, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America 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.