Stryker Communications

Complete recall history across all FDA and CPSC categories — 18 total recalls

Stryker Communications appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (18)

FDA medical device enforcement actions by Stryker Communications

Date Product Reason Class
Feb 23, 2026 Stryker CHROMOPHARE Softlit Ring Surgical Light System REF: CH00000001 Surgical light assembly may not adequate support the weight of the ceiling c... Class II
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 indica... Class II
Feb 8, 2024 Chromophare Surgical Light System , REF CH00000001 Due to insufficient mounting force the stability of surgical light system can... Class II
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-Serie... Class II
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... Class II
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
Mar 22, 2019 Berchtold Chromophare F528 Surgical Lights. Product Usage: The medical ... The back cover of the light head was insufficiently assembled and could poten... Class II
Mar 22, 2019 Berchtold Chromophare F628 Surgical Lights. Product Usage: The medical ... The back cover of the light head was insufficiently assembled and could poten... Class II
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 insufficien... Class II
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 potenti... Class II
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
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 co... Class II
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... Class II
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 ... Class II
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 ... Class II
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 ... Class II
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 ... Class II
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 ... Class II
Jul 25, 2013 Stryker Visum 300 Ceiling-mounted Exam Light. Potential incomplete final weld on the drop tube flange. Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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