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Browse Device Recalls

261 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 261 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 261 FDA device recalls.

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DateProductReasonClassFirm
Sep 19, 2011 .***ANSPACH***Sterile. REF SHD-4820DS***QTY: 1, 4.8 mm x 2mm Twist Drill with... Anspach Effort, Inc. Palm Beach Gardens, FL is recalling their Single Use Sterile Bone Cutting B... Class II The Anspach Effort, Inc.
Sep 9, 2011 Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips. Rx Only Recall was initiated due to the observation of separation between clear layers of the pouch durin... Class II The Anspach Effort, Inc.
Jun 24, 2011 ***REF SC2101***eMax 2 Plus Console, Single Port, with Irrigation***SN G17307... The RPM of the Motor Handpiece may be less than 80,000 RPM. Class II The Anspach Effort, Inc.
Jun 24, 2011 ***REF SC2102***eMax 2 Plus Console, Single Port, no Irrigation***SN G1630788... The RPM of the Motor Handpiece may be less than 80,000 RPM. Class II The Anspach Effort, Inc.
Jun 24, 2011 ***REF SC2100***eMax 2 Plus Console***SN G 10307653002*** Product Usage: ... The RPM of the Motor Handpiece may be less than 80,000 RPM. Class II The Anspach Effort, Inc.
May 6, 2011 Pneumatic Systems Operating Manual (part numbers 19-0005) utilized with the P... Anspach Effort, Inc. Palm Beach Gardens, FL initiated a correction of its medical Device labeling... Class II The Anspach Effort, Inc.
May 6, 2011 Cutting Bur Chart (part number 20-0019) utilized with the Electric and Pneuma... Anspach Effort, Inc. Palm Beach Gardens, FL initiated a correction of its medical Device labeling... Class II The Anspach Effort, Inc.
May 6, 2011 Product Catalog (part number 20-0020) utilized with the Electric and Pneumati... Anspach Effort, Inc. Palm Beach Gardens, FL initiated a correction of its medical Device labeling... Class II The Anspach Effort, Inc.
Mar 31, 2011 Anspach REF: TURQ-434-4 Twist Drill for 1.5mm x 4mm screw. Rx only Single... Cutter was longer than was stated on the label Class II The Anspach Effort, Inc.
Mar 31, 2011 AnspacSingle use Sterile bone cutting burs.h REF: S-1504TD Twist Drill for 1.... Cutter was longer than was stated on the label Class II The Anspach Effort, Inc.
Mar 4, 2011 ***REF S-3D*** 3mm Diamond Ball. Used for cutting and shaping bone. Due to three batches of product may have diamond grit size larger than intended applied to the he... Class II The Anspach Effort, 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.