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Browse Device Recalls

29 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 29 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 29 FDA device recalls.

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DateProductReasonClassFirm
Feb 28, 2025 Monterey AL Implant Inserter; 22mm; Catalog 48019140. Potential for the gold unlock button to separate from the inserter. Class II Stryker Spine
Feb 28, 2025 Monterey AL Implant Inserter; 18/20mm; Catalog 48019130. Potential for the gold unlock button to separate from the inserter. Class II Stryker Spine
Feb 28, 2025 Monterey AL Implant Inserter; 10/12mm; Catalog 48019100. Potential for the gold unlock button to separate from the inserter. Class II Stryker Spine
Feb 28, 2025 Monterey AL Implant Inserter; 14/16mm; Catalog 48019120. Potential for the gold unlock button to separate from the inserter. Class II Stryker Spine
Aug 23, 2024 AVS Anchor-C Cervical Cage System Instructions For Use (IFU)- eIFU (revision ... Labeling Correction: Instructions For Use (IFU)-Updated electronic Rev 5, specific language for ... Class II Stryker Spine
Nov 1, 2023 LITe Decompression Snake Arm, REF 48080230 Product arm was manufactured with the incorrect clamp component. As a result, the affected produc... Class II Stryker Spine
May 18, 2021 Cortoss Bone Augmentation Material 10cc Cartridge, Catalog Number 2101-0010, ... The products experienced a 12-hour excursion from the required refrigerated temperature condition... Class II Stryker Spine
May 18, 2021 Cortoss Bone Augmentation Material 5cc Cartridge, Catalog Number 2101-0005, G... The products experienced a 12-hour excursion from the required refrigerated temperature condition... Class II Stryker Spine
Mar 11, 2021 Tritanium X TL Instruments - intervertebral fusion device with bone graft, lu... Stryker identified non-conforming instruments that are components of the Tritanium X TL sets. The... Class II Stryker Spine
Aug 13, 2018 AVS Aria Cage, Catalog Number 48753212 Product Usage: The Stryker Spine A... The anterior and posterior markers on the cage were on the incorrect/opposite sides of the cage. Class II Stryker Spine
Dec 18, 2015 Stryker Aero-AL Impaction handle Catalog Number 48921007. Stryker Spine Manu... Reported jamming of the impaction handle when assembled to the Inserter guide at the threads. Class II Stryker Spine
Dec 16, 2015 AccuLIF PL Tubing Set and AccuLIF TL Tubing Set AccuLIF is an interbody de... There were two potential interference conditions identified with the way the tubing set attaches ... Class II Stryker Spine
Sep 25, 2015 Stryker Radius 5.5 to 3.5 Rod to Red Connector, REF 48664530. Intended to p... Stryker Spine is recalling Radius Rod to Rod Connector 5.5 to 3.5 mm (Catalog #486614530) because... Class II Stryker Spine
Sep 8, 2015 Stryker UniVise Spinous Process Fixation Plate System Inserter, Stryker Spine... The Inserter Inner Shaft would not fit through the Inserter. The inner diameter of the cannulated... Class II Stryker Spine
Oct 6, 2014 Specialty Audible Torque Wrench Mfg by: Stryker Spine, Catalog number IS3002X... Stryker has received a complaint from customers relating to a fracture during the use of the Spec... Class II Stryker Spine
Jul 7, 2014 Specialty Aria Inserter, REF IS3021ARI, Non-Sterile, This instrument is ... Stryker has initiated the recall of its Aria Standard and Specialty Implant Inserters due to comp... Class II Stryker Spine
Jul 7, 2014 Stryker Aria Implant Inserter, REF 48758500, This instrument is part of ... Stryker has initiated the recall of its Aria Standard and Specialty Implant Inserters due to comp... Class II Stryker Spine
Dec 18, 2013 Specialty Straight Static Inserter Assembly Product Usage: This instru... Stryker has received complaints from customers relating to fracture along the weld that binds the... Class II Stryker Spine
Sep 24, 2013 Stryker 1) XIA Torque Wrench 2) XIA 3 Torque Wrench 3) XIA Elegance Short... Multiple complaints have reported that the hex tip of the torque wrench fracturing during final t... Class II Stryker Spine
May 30, 2013 Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long... Stryker has received reports from customers indicating post-operative fracture of the pin that c... Class I Stryker Spine
Dec 27, 2012 Stryker XIA 3 Iliac Screwdriver, 3-PCS. The XIA 3 Iliac Screwdriver is u... Surgeons have experienced unthreading of the screwdrivers outer shafts during use. Class II Stryker Spine
Aug 9, 2012 Stryker XIA 3 TORQUE WRENCH REF 48237028 Manufactured by: Stryker pine... Multiple complaints have reported the hex tip of the torque wrench fracturing during final tighte... Class II Stryker Spine
Aug 9, 2012 Stryker MANTIS TORQUE WRENCH REF 48287028 Manufactured by: Stryker pin... Multiple complaints have reported the hex tip of the torque wrench fracturing during final tighte... Class II Stryker Spine
Aug 9, 2012 SPECIALTY AUDIBLE TORQUE WRENCH, XIA IS2217XLP MFG BY: STRYKER SPINE ... Multiple complaints have reported the hex tip of the torque wrench fracturing during final tighte... Class II Stryker Spine
Jul 5, 2012 Aviator Drill Bit (10 mm, 12 mm, 14 mm, 16 mm, Manufactured by: Stryker Spi... Aviator drill bits are 10 mm longer than the Reflex Hybrid drill bits and are not interchangeable... Class II Stryker Spine
Apr 25, 2012 The Instructions For Use for the following: Stryker TRIO+ 4.5 x 45 mm STANDA... The front cover of Instructions For Use (IFU) #NOLI135B03Rev02 was improperly marked with a "Ster... Class II Stryker Spine
Apr 23, 2012 LUXOR RETRACTOR BASE; Catalog Number: 48250030; Manufactured by: STRYKER Spin... Stryker received three reports involving blades of the Luxor Retractor becoming disassembled from... Class II Stryker Spine
Jan 13, 2012 Stryker AVS Navigator Trials 6mm-15mm Manufactured by: Stryker Spine SAS Z... Beginning in February 2011, Stryker Spine began receiving reports related to the shaft of the AVS... Class II Stryker Spine
Mar 21, 2011 Stryker Reliance AL Implant Blocker (Various sizes) The SLIDE Implant Blo... Stryker Spine has received six reports regarding the breakage of one or more prongs at the extrem... Class II Stryker Spine

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.