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Browse Device Recalls

19 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 19 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 19 FDA device recalls.

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DateProductReasonClassFirm
Jul 15, 2025 Chromophare Surgical Light System, REF: CH00000001; SLX to Oculan NFC Upgrade... Surgical lights have stress lines forming on the powder coating, which indicates that powder coat... Class II Stryker Communications
Feb 8, 2024 Chromophare Surgical Light System , REF CH00000001 Due to insufficient mounting force the stability of surgical light system cannot be guaranteed. Class II Stryker Communications
Jan 29, 2021 S-Series Equipment Management System; Model Number(s):0682400550; UDI: 076133... The manufacturer has become aware that there is a likelihood that the S-Series Equipment Manageme... Class II Stryker Communications
Oct 11, 2019 Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000000 The firm has become aware that there is a likelihood that a missing snap ring or spanner nut may ... Class II Stryker Communications
Aug 1, 2019 Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a componen... The mounts on the monitor may have an insufficient weld. Class II Stryker Communications
Mar 22, 2019 Berchtold Chromophare F528 Surgical Lights. Product Usage: The medical ... The back cover of the light head was insufficiently assembled and could potentially fall off the ... Class II Stryker Communications
Mar 22, 2019 Berchtold Chromophare F628 Surgical Lights. Product Usage: The medical ... The back cover of the light head was insufficiently assembled and could potentially fall off the ... Class II Stryker Communications
Nov 13, 2018 EDS Light Suspension, Central Axis, a component of the Stryker Visum LED Surg... There is a potential the joint in the suspension of the device is insufficiently assembled. Class II Stryker Communications
Jan 29, 2018 Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000... The device could have a missing spanner nut and snap ring which could potentially result in the e... Class II Stryker Communications
Jan 26, 2018 Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a componen... The mounts on the monitor may have an insufficient (missing or incomplete) weld. Class II Stryker Communications
Apr 21, 2017 Berchtold Chromophare F300 Exam Light CHROMOPHARE examination lights are med... The exam light may have a tolerance issue with the adapter assembly, which could potentially not ... Class II Stryker Communications
Feb 28, 2017 The Stryker Visum¿ LED Surgical Lighting system is intended to illuminate the... The potential hazard that can arise for the combination of the missing screws and the overloading... Class II Stryker Communications
Mar 17, 2014 SHAPE ARM, SINGLE, an articulating, arm bracket that is attached to the servi... During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the S... Class II Stryker Communications
Mar 17, 2014 BAM (SHAPE) ARM, LEFT, an articulating, arm bracket that is attached to the s... During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the S... Class II Stryker Communications
Mar 17, 2014 BAM (SHAPE) ARM, RIGHT, an articulating, arm bracket that is attached to the ... During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the S... Class II Stryker Communications
Mar 17, 2014 SHAPE ARM, DUAL SH2, an articulating, arm bracket that is attached to the ser... During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the S... Class II Stryker Communications
Mar 17, 2014 SHAPE ARM, SINGLE WITH GCX MOUNT, an articulating, arm bracket that is attach... During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the S... Class II Stryker Communications
Jul 25, 2013 Stryker Visum 300 Ceiling-mounted Exam Light. Potential incomplete final weld on the drop tube flange. Class II Stryker Communications
Sep 25, 2012 (l) Visum Halogen Surgical Light, (2) Visum LED Surgical Light, (3) Stryker F... Stryker has become aware that there is a low likelihood of incomplete engagement of the Spring Ar... Class II Stryker Communications, 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.