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Browse Device Recalls

22 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 22 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 22 FDA device recalls.

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DateProductReasonClassFirm
Nov 30, 2015 Columbus Revision Knee System, EnduRo Knee System Product Usage: The Colu... Aesculap Inc. US has initiated a recall on Tibial and Femur extension sterile pressfit stem impla... Class II Aesculap, Inc.
Nov 17, 2015 Valve XS Atrium Retractor FC429R 52154756 The Valve XS Atrium Lift Retra... AAG received a customer complaint that corrosion had been found by a hospitals central sterile s... Class II Aesculap, Inc.
Nov 10, 2015 Flexible Bone Awl; SJ607R; NON STERILE; B Braun Aesculap; Aesculap AG:... The flexible shaft of the instruments may break during orthopedic spinal surgery. There is a ris... Class II Aesculap, Inc.
Nov 10, 2015 Tray Set containing multiple instruments and may contain the flexible bone aw... The flexible shaft of the instruments may break during orthopedic spinal surgery. There is a ris... Class II Aesculap, Inc.
Nov 10, 2015 Flexible Drill; SJ723R; NON STERILE; B Braun Aesculap; Aesculap AG ... The flexible shaft of the instruments may break during orthopedic spinal surgery. There is a ris... Class II Aesculap, Inc.
Nov 10, 2015 Flexible Screw Driver SJ706R; Non Sterile; B Braun; Aesculap; Aescul... The flexible shaft of the instruments may break during orthopedic spinal surgery. There is a ris... Class II Aesculap, Inc.
Jul 7, 2015 S4C Occiput Torque Wrench F/Set Screw; used to tighten the S4 Cervical Spinal... A FW103R torque wrench that was improperly reassembled after reprocessing caused a screw to break... Class II Aesculap, Inc.
Dec 17, 2014 Miethke Shunt System accessories Product Usage: - The Miethke Shunt Syst... Some Miethke Shunt System accessories may have an incorrect MR safety symbol on the shelf box lab... Class II Aesculap, Inc.
Nov 11, 2014 Aesculap Miethke Shunt System, miniNAV Valve: The Miethke Shunt System is int... Aesculap Inc. (AIC (USA)) initiated a recall of Miethke Shunt System accessories due to missing p... Class III Aesculap, Inc.
Oct 24, 2014 The Dual Switch Valve is used for fluid drainage from the ventricles into the... Aesculap Inc. (AIC (USA)) initiated a recall of Miethke Shunt System, Dual Switch Valve, due to i... Class II Aesculap, Inc.
Jun 13, 2014 Dafilon Suture Black 10/0 (0.2) 15 cm DRM4 NS, non-sterile, non-absorbable p... Aesculap Inc. (AIC (USA)) has initiated a voluntary recall of Dafilon Black 10/0 (0.2) 15 cm DRm4... Class II Aesculap, Inc.
Apr 21, 2014 Aesculap Inc.(AIC) Miethke Ventricular Catheter with Deflector/Miethke Shunt ... AIC (USA) received information regarding 3 complaints in which the deflector did not move freely ... Class II Aesculap, Inc.
Dec 23, 2013 Aesculap proSA Adjustment Disc Size Large (L) The Miethke proSA Adjustment... The accuracy is out of specification for the Aesculap proSA Adjustment Disc Size L. Class II Aesculap, Inc.
Dec 9, 2013 Aesculap Hi-Line XXS handpiece Hi-Line XXS handpieces are used with the Hi... Certain lots of the Aesculap Hi Line XXS handpiece (part # GB790R) were recalled due to a possibl... Class II Aesculap, Inc.
Sep 20, 2013 Aesculap Arcadius XP L Trial Insertion Instrument (ME020R/ME020R-US) The trial insertion instrument may disassemble during use due to a potentially weak weld on then ... Class II Aesculap, Inc.
Sep 19, 2013 Aesculap Columbus Revision CoCr 15mm distal and posterior spacers, sizes F5-F7 The Columbus Revision CoCr 15 mm distal and posterior implant spacers, sizes F5-F7, were not comp... Class II Aesculap, Inc.
Sep 10, 2013 Aesculap GNI161 Bipolar Foot Control Product Usage: The Aesculap Bipolar ... Complaints were received for the GN161 Bipolar Foot Control reporting that the bipolar energy did... Class II Aesculap, Inc.
Jul 16, 2013 UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical inst... Changes were implemented to the UNITRAC instructions for use to ensure safe use and potentially e... Class II Aesculap, Inc.
Jun 18, 2013 ProSpace Peek Implant 5 degree x 8.5 x 22 mm The device is intended for v... Aesculap Implant Systems, LLC initiated a recall of the Aesculap Prospace PEEK 5 degree Implant -... Class II Aesculap, Inc.
Jan 18, 2013 Aesculap Bipolar Generator Foot Pedal, Catalog No. GK226, for electrosurgical... The bipolar energy did not stop after release of the foot pedal. Class II Aesculap, Inc.
Jun 4, 2012 Aesculap(R) - Miethke Shunt System, FT040T - Control Reservoir Set w/Distal C... The deflector may not move freely on the ventricular catheter. The deflector comes pre-positione... Class II Aesculap, Inc.
May 9, 2012 Columbus 4-IN-1 Femoral Cutting Guide M3 Instrument (NQ083R) The manufacturer informed the recalling firm of a potential laser marking error in size identific... Class II Aesculap, 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.