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Browse Device Recalls

39 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 39 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 39 FDA device recalls.

Clear
DateProductReasonClassFirm
Jun 13, 2022 Yukon Straight Rod 4.0 x120mm; Cat# 7601-540120. Used to provide immobiliz... Some of the rods in this lot were observed to have discoloration, later confirmed to be indicatio... Class II K2M, Inc.
Jan 13, 2022 Everest MI XT Outer Dilator, Catalog Number 5101-90168 Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not ... Class II K2M, Inc
Jan 13, 2022 Everest MI XT Inner Dilator, Catalog Number 5101-90167 Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not ... Class II K2M, Inc
Sep 8, 2021 Chesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-90068 Units may arrive with missing pins and/or in a state in disassembly. Pins dislodging from the ins... Class II K2M, Inc
May 7, 2021 Cascadia AN Interbody Convex 10x22x14mm Catalog Number: 6101-2102214NC-G2 ... Mislabeled product labeling references incorrect length or height, or length and height for speci... Class II K2M, Inc
May 7, 2021 Cascadia AN Interbody Convex 10x22x15mm Catalog Number: 6101-2102215NC-G2 ... Mislabeled product labeling references incorrect length or height, or length and height for speci... Class II K2M, Inc
May 7, 2021 Cascadia AN Interbody Convex 10x28x14mm Catalog Number: 6101-2102814NC-G2 ... Mislabeled product labeling references incorrect length or height, or length and height for speci... Class II K2M, Inc
Mar 16, 2021 Chesapeake Cervical-Ti 10mm Drill Guide Inserter- a multi-screw construct pro... Interference condition between the 10mm Drill Guide Inserter and the inner shaft that mates with ... Class II K2M, Inc
Dec 14, 2020 Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component o... The Yukon polyaxial screw used in the Yukon Spinal System was incorrectly laser marked with size ... Class II K2M, Inc
Nov 4, 2020 Everest MI XT Tab Removal Tool (i.e. All-In-One Tab Removal Tool)-used to bre... All-in-One Tab Removal Tool may cause cracking and/or separating at the threaded interface betwee... Class II K2M, Inc
Nov 3, 2020 Yukon OCT Spinal System Yukon Anti-Torque Alignment Tube - Product Usage: The... Shafts do not pass through the inner cannula of the Anti-Torque Alignment Tube from Lot KTGG due ... Class II K2M, Inc
Apr 13, 2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together... Class II K2M, Inc
Apr 13, 2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together... Class II K2M, Inc
Apr 13, 2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together... Class II K2M, Inc
Apr 13, 2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together... Class II K2M, Inc
Apr 13, 2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together... Class II K2M, Inc
Apr 13, 2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together... Class II K2M, Inc
Apr 13, 2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together... Class II K2M, Inc
Apr 13, 2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together... Class II K2M, Inc
Apr 13, 2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together... Class II K2M, Inc
Apr 13, 2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together... Class II K2M, Inc
Apr 13, 2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together... Class II K2M, Inc
Apr 13, 2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together... Class II K2M, Inc
Apr 13, 2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together... Class II K2M, Inc
Apr 13, 2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together... Class II K2M, Inc
Apr 13, 2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together... Class II K2M, Inc
Apr 13, 2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together... Class II K2M, Inc
Apr 13, 2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together... Class II K2M, Inc
Apr 13, 2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together... Class II K2M, Inc
Apr 13, 2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together... Class II K2M, Inc
Apr 13, 2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together... Class II K2M, Inc
Apr 13, 2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together... Class II K2M, Inc
Apr 13, 2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together... Class II K2M, Inc
Apr 13, 2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together... Class II K2M, Inc
Apr 13, 2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together... Class II K2M, Inc
Apr 18, 2019 Fenestrated Tap Adapter (REF# 5001-90011) Product Usage: The K2M Fenestra... The products are mislabeled. Class II K2M, Inc
Apr 18, 2019 Fenestrated Taps 4.5mm, 5.5mm, 6.5mm (Ref#5001-90013, 5001-90014, 5001-90015)... The products are mislabeled. Class II K2M, Inc
Jul 24, 2018 YUKON Polyaxial Screws (3.5 X 12 mm, Owning Site: Leesburg USA 3.5 X 14 mm, ... Screws had a manufacturing error that could prevent the screw from mating with the screw inserter... Class II K2M, Inc
Dec 2, 2016 K2M Special Connector Instruments (Special Connector, Special Adaptor, and Qu... Instruments were developed without adequate consideration given to the need for a new regulatory ... Class II K2M, 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.