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Browse Device Recalls

11 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 11 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 11 FDA device recalls.

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DateProductReasonClassFirm
Oct 6, 2014 Accusorb MRI MAC7010 Product Usage: Radio frequency shielding blanket... When not used correctly, Accusorb MRI products may overheat and lead to patient injury. Class II MWT Materials, Inc.
Oct 6, 2014 Accusorb MRI MAC7003 Part Number: MRI-03 U (Upper) and MRI-03 L (Lower) P... When not used correctly, Accusorb MRI products may overheat and lead to patient injury. Class II MWT Materials, Inc.
Oct 6, 2014 Accusorb MRI MAC7001 Part Number: MRI-01 MRI-Large Blanket Various Sizes ... When not used correctly, Accusorb MRI products may overheat and lead to patient injury. Class II MWT Materials, Inc.
Oct 6, 2014 Accusorb MRI MAC7002 Part Number: MRI-02 MRI-Arm Sleeve Various Sizes ... When not used correctly, Accusorb MRI products may overheat and lead to patient injury. Class II MWT Materials, Inc.
Oct 6, 2014 Accusorb MRI MAC7005 Part Number: MRI-05 Leg Wrap Product Usage: Radio... When not used correctly, Accusorb MRI products may overheat and lead to patient injury. Class II MWT Materials, Inc.
Oct 6, 2014 Accusorb MRI MAC7008 Part Number: MRI-08 MRI-Boot Product Usage: Radi... When not used correctly, Accusorb MRI products may overheat and lead to patient injury. Class II MWT Materials, Inc.
Oct 6, 2014 Accusorb MRI MAC7030 Product Usage: Radio frequency shielding blanket... When not used correctly, Accusorb MRI products may overheat and lead to patient injury. Class II MWT Materials, Inc.
Oct 6, 2014 Accusorb MRI MAC7004 Part Number: MRI-04 MRI-Poncho Product Usage: Ra... When not used correctly, Accusorb MRI products may overheat and lead to patient injury. Class II MWT Materials, Inc.
Oct 6, 2014 Accusorb MRI MAC7006 Part Number: MRI-06 MRI-Large Torso Wrap Product U... When not used correctly, Accusorb MRI products may overheat and lead to patient injury. Class II MWT Materials, Inc.
Oct 6, 2014 Accusorb MRI MAC7009 Part Number: MRI-09 MRI- Leg Wrap Blanket Various Si... When not used correctly, Accusorb MRI products may overheat and lead to patient injury. Class II MWT Materials, Inc.
Oct 6, 2014 Accusorb MRI MAC7007 Part Number: MRI-07 MRI-Breast Shield Product Usa... When not used correctly, Accusorb MRI products may overheat and lead to patient injury. Class II MWT Materials, 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.