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Browse Device Recalls

10 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 10 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 10 FDA device recalls.

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DateProductReasonClassFirm
Jun 13, 2018 O-SPOT REF 791, 791S Adhere to skin for marking and identifying moles in ... There is a potential for imaging artifact to mimic calcifications on patient's mammograms Class II Beekley Corporation
Jun 13, 2018 TomoSPOT REF 782, 782S, 783, 783S, 784, 784S, 785 & 785S Adhere to skin f... There is a potential for imaging artifact to mimic calcifications on patient's mammograms Class II Beekley Corporation
Jun 13, 2018 S-SPOT REF 777, 777S Adhere to skin for marking and identifying moles in ... There is a potential for imaging artifact to mimic calcifications on patient's mammograms Class II Beekley Corporation
May 8, 2017 Beekley Medical 0-SPOT Mammography Skin Markers REF 652 Mammography Skin Marker 0 -SPOT (REF 652) product was mis-labeled with A-SPOT (REF 651) labels Class III Beekley Corporation
Jun 19, 2013 Beekley Spots Light Image O-Spots for Mammography Catalog Number: 252 Pro... Light Image O-Spots Dispenser mislabeled as Soft n' Stretchy Light Image S-Spots Class III Beekley Corporation
Jul 9, 2012 Beekley O-Spots Floral Skin Markers -Order Number: 752 Product Usage: Mam... Digital Skin Mammography Marker separating from the backing of the spot material Class II Beekley Corporation
Jul 9, 2012 Beekley A-Spots Floral Skin Markers -Order Number: 751 Product Usage: Mam... Digital Skin Mammography Marker separating from the backing of the spot material Class II Beekley Corporation
Jul 9, 2012 Beekley S-Spots Floral Skin Markers -Order Number: 750 Product Usage: Mam... Digital Skin Mammography Marker separating from the backing of the spot material Class II Beekley Corporation
Jul 9, 2012 Beekley Altus Floral Skin Markers -Order Number: 754 Product Usage: desig... Digital Skin Mammography Marker separating from the backing of the spot material Class II Beekley Corporation
Jul 2, 2012 Bella Blanket Protective Coverlet, for Mammography, 18cm x 25cm or 24cm x 30c... Imaging artifact can occur on mammogram result Class II Beekley Corporation

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.