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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
Apr 13, 2015 ANSPACH - 2.3MM Fluted Matchstick, Extends 22MM; REF S-8N-L-G1 Cutting s... G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... Class II The Anspach Effort, Inc.
Apr 13, 2015 ANSPACH - 4MM x 11 MM Fluted Barrel, 14 Flutes; REF M-4BA-A-G1. Cutting sh... G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... Class II The Anspach Effort, Inc.
Apr 13, 2015 ANSPACH - Extra Coarse Diamond Ball; 8MM REF L-8DX-G1 Cutting shaping bo... G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... Class II The Anspach Effort, Inc.
Apr 13, 2015 ANSPACH - Fluted Drum, Side Cut only, 6MM x 14MM REF L-6DRC-G1 Cutting sh... G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... Class II The Anspach Effort, Inc.
Apr 13, 2015 ANSPACH - Fluted Acorn, 7MM REF L-7AC-G1 Cutting shaping bone including s... G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... Class II The Anspach Effort, Inc.
Apr 13, 2015 ANSPACH - 4MM Diamond Ball, Extends 27MM; REF S-4D-L-G1 all lot numbers Cu... G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... Class II The Anspach Effort, Inc.
Apr 13, 2015 ANSPACH - Fluted Drum, Side Cut Only; 7MM x 14MM REF L-7DRC-G1 Cutting s... G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... Class II The Anspach Effort, Inc.
Apr 13, 2015 ANSPACH - 5MM Diamond Ball, 2MM Shaft Exposure; REF S-5D-2-G1 Cutting s... G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... Class II The Anspach Effort, Inc.
Apr 13, 2015 ANSPACH - Fluted Barrel; 8MM x 12.5MM REF L-8BA-G1 Cutting shaping bone ... G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... Class II The Anspach Effort, Inc.
Apr 13, 2015 ANSPACH - 8MM x 12.5MM Fluted Barrel; REF M-8BA-G1 Cutting shaping bone... G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting t... Class II The Anspach Effort, Inc.
Mar 24, 2015 Synthes Small Battery Drive (SBD) Oscillating Saw Attachment Part Number: 532... The potential exists for the Oscillating Saw Attachment to disengage from the Small Battery Drive... Class II The Anspach Effort, Inc.
Dec 10, 2014 16cm Minimally Invasive Attachment. For use with Motor Systems for cutting a... Customer complaint indicating the color bands on the MIA16-G1 were not correct. Class II The Anspach Effort, Inc.
Nov 14, 2014 Synthes Small Electric Drive (SED) May operate solely in reverse mode, not operate in reverse mode when intended, not function or an... Class II The Anspach Effort, Inc.
Aug 14, 2014 Synthes Small Electric Drive (SED). For use in general traumatology. The affected Small Electric Drive (SED) may operate solely in reverse mode, not operate in revers... Class II The Anspach Effort, Inc.
May 8, 2014 Anspach Pneumatic and Electric Motor Systems. Intended for cutting and sha... Several attachments and handpieces failed to meet the expected sterility assurance level (SAL) wh... Class II The Anspach Effort, Inc.
Jan 8, 2014 ANSPACH Cutting bur, 3 mm Diamond Ball, Standard Length. REF L-3SD Use with L... Anspach product code L-3SD contained product code S-3SD which is shorter in length than the label... Class II The Anspach Effort, Inc.
Dec 17, 2013 Anspach Carbide Cutting Burrs & Drums: 2MM Carbide Fluted Ball, Extended par... Some carbide cutting burr fractured during use. Class II The Anspach Effort, Inc.
Dec 17, 2013 Anspach Carbide Cutting Burrs: 1.5MMx7.5MM Cylindrical Carbide Drum part # S... Some carbide cutting burr fractured during use. Class II The Anspach Effort, Inc.
Dec 17, 2013 Anspach Carbide Cutting Burrs & Drums: 1.5MM x 7.5MM Cylindrical Carbide Dru... Some carbide cutting burr fractured during use. Class II The Anspach Effort, Inc.
Dec 17, 2013 Anspach Carbide Cutting Burrs: 2MM Carbide Fluted Ball, Standard, 8 Flutes -... Some carbide cutting burr fractured during use. Class II The Anspach Effort, Inc.
Dec 3, 2013 Anspach Irrigation Clip 40 Product Usage: Irrigation clips provide a meth... The Irrigation Clips were assembled with the incorrect (smaller) clips. Class II The Anspach Effort, Inc.
May 6, 2013 Anspach MIA 16 (16cm Minimally Invasive Attachment), Rx Only MIA16 attachm... Product did not reach expected sterility assurance level Class II The Anspach Effort, Inc.
Apr 25, 2013 ***REF MICROMAX***microMax Handpiece***Rx Only***Manufacturer: The Anspach Ef... The firm Anspach Effort of Palm Beach Gardens, FL initiated a voluntary removal of the Pneumatic ... Class II The Anspach Effort, Inc.
Apr 25, 2013 ***REF BLACKMAX-N***Swivel/Angle Motor Assembly***Rx Only***The Anspach Effor... The firm Anspach Effort of Palm Beach Gardens, FL initiated a voluntary removal of the Pneumatic ... Class II The Anspach Effort, Inc.
Apr 25, 2013 ***REF XMAX***XMax Handpiece***Rx Only***Manufacturer: The Anspach Effort, In... The firm Anspach Effort of Palm Beach Gardens, FL initiated a voluntary removal of the Pneumatic ... Class II The Anspach Effort, Inc.
Apr 25, 2013 ***REF IMRI-MOTOR***iMRI Handpiece. Use with iMRI System Only***Rx Only***Man... The firm Anspach Effort of Palm Beach Gardens, FL initiated a voluntary removal of the Pneumatic ... Class II The Anspach Effort, Inc.
Nov 28, 2012 ANSPACH***Custom XMax Motor, Pneumatic***Rx Only*** This device is intende... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... Class II The Anspach Effort, Inc.
Nov 28, 2012 ANSPACH***REF 98-0043***Custom Device eMax 2 Plus Hand Control that will work... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... Class II The Anspach Effort, Inc.
Nov 28, 2012 ANSPACH***REF SP-5001-00***20 degree Angle Driver (MA-D20) - Custom***Rx Only... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... Class II The Anspach Effort, Inc.
Nov 28, 2012 ANSPACH***REF 98-0025***Custom MDA Tube for use with MA-D20 Attachment***Rx O... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... Class II The Anspach Effort, Inc.
Nov 28, 2012 ANSPACH***REF 98-0008***7cm Medium Attachment Custom***Rx Only*** This dev... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... Class II The Anspach Effort, Inc.
Nov 28, 2012 ANSPACH***REF 98-0021***eMax2 Console with Irrigation***Rx Only*** This de... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... Class II The Anspach Effort, Inc.
Nov 28, 2012 ANSPACH***REF 98-0003***Sagittal microSaw Attachment Custom***Rx Only*** T... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... Class II The Anspach Effort, Inc.
Nov 28, 2012 ANSPACH***REF-98-0062***Custom Device eMax2 Plus Hand Control***Rx Only*** ... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... Class II The Anspach Effort, Inc.
Nov 28, 2012 ANSPACH***REF 98-0029***8 mm Coarse Threaded Headless Bone Screw***Rx Only***... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... Class II The Anspach Effort, Inc.
Nov 28, 2012 ANSPACH***Knotless Suture Anchor Deployment Tool, Custom***Rx Only*** Thi... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling the Anspach Custom Devices. The u... Class II The Anspach Effort, Inc.
Nov 28, 2012 ANSPACH***REF 98-0044***Custom Device Speed Reducer with Bumper***Rx Only*** ... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... Class II The Anspach Effort, Inc.
Nov 28, 2012 ANSPACH***1.85mm x 16 mm Fluted Router for MRI***Rx Only*** This device is... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... Class II The Anspach Effort, Inc.
Nov 28, 2012 ANSPACH***REF 98-0024***Nose Cone Cover***Rx Only*** This device is intend... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... Class II The Anspach Effort, Inc.
Nov 28, 2012 ANSPACH***REF 98-0031***Custom Medium Attachment, with 5 mm Extended Tapered ... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... Class II The Anspach Effort, Inc.
Nov 28, 2012 ANSPACH***REF 98-0012***Shoulder Implant 011mm Rod, 20cm Long, Custom***Rx On... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... Class II The Anspach Effort, Inc.
Nov 28, 2012 ANSPACH***REF-98-0056***Custom Device Autolube III modified with a swivel***R... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... Class II The Anspach Effort, Inc.
Nov 28, 2012 ANSPACH***REF SP-3100-00***5mm Coarse Diamond Ball, 11.5 OAL***Rx Only*** ... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... Class II The Anspach Effort, Inc.
Nov 28, 2012 ANSPACH***REF 98-0001***eMax Hand Control***Rx Only*** This device is inte... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... Class II The Anspach Effort, Inc.
Nov 28, 2012 ANSPACH***REF SP-4602-00***2mm Coarse Diamond Ball for Adjustable 25cm Mia At... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... Class II The Anspach Effort, Inc.
Nov 28, 2012 ANSPACH***REF SP-4603-00***3mm Coarse Diamond Ball for Adjustable 25cm Mia At... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... Class II The Anspach Effort, Inc.
Nov 28, 2012 ANSPACH***REF 98-0010***2.37mm Spiral Drill, for Short Attachment (Non-Steri... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... Class II The Anspach Effort, Inc.
Nov 28, 2012 ANSPACH***REF 98-0037***Custom Device SC2102 with fast stop firmware***Rx Onl... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... Class II The Anspach Effort, Inc.
Nov 28, 2012 ANSPACH***Custom MCA5-1SD with Extended Exposure***Rx Only*** This device ... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... Class II The Anspach Effort, Inc.
Nov 28, 2012 ANSPACH***REF SP-3101-00***Adjustable 25 Cm Mia Attachment, Custom***Rx Only*... The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... 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.