Recall archive
12 recalls · page 1 of 1
Reported May 18, 2016
CinchLock SS Knotless Anchor with Inserter; Model number CAT02462; Orthopedic: The Pivot CinchLock SS Knotless Anchor…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Corporation
Matched: Brand · Reason for recall — Stryker Endoscopy is recalling the CinchLock SS Knotless Anchor with Inserter and the CinchLock Flex Anchor with Inserter after 13 reports of s of an…
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 4, 2016
PneumoSure XL High Flow Insufflator and PneumoSure High Flow Insufflator; High pressure units (HPU) (40L and 45L).…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Endoscopy
Matched: Brand — When operating the device in high flow mode (40L/min, 15 mmHg) and connecting to a house gas inlet source, within seconds of insufflating the flow…
FDA (openFDA device enforcement)
Reported Jul 1, 2015
SERFAS 90 degree Energy Probe, Part Number 279-350-101; SERFAS Energy Probes are indicated for arthroscopic procedures…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Endoscopy
Matched: Brand · Reason for recall — Stryker Endoscopy is recalling all non expired SERFAS 90 degree Energy Probes due to reports of fragments of the probe breaking off into the patient.
FDA (openFDA device enforcement)
Reported Dec 24, 2014
PKG, BIPOLAR FORCEPS, MICRO TIP, 45CM, P/N 0250080115 nationwide in US and worldwide: Algeria, Argentina, Australia,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Endoscopy
Matched: Brand — The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the…
206 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 17, 2014
1488 HD 3-Chip Camera; Model Number 1488-210-105 - C-Mount. Product Usage: High definition camera to view endoscopic…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Endoscopy
Matched: Brand · Product · Product details — In certain operating room environments, a colored screen image occurs with the 1488 Cameras that were manufactured during a specific time period
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 30, 2014
Disposable StrykeFlow Tip, Stryker Disposable Suction/I irrigator Tip; Sterile, Rx only, Latex Free. Stryker Suction…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Endoscopy
Matched: Brand · Product · Product details — Internal review found that six lots of Disposable StrykeFlow Tips were shipped with a potentially deformed blister pouch which could impact sterility…
FDA (openFDA device enforcement)
Reported Jul 2, 2014
Shaver Handpiece Sterilization Tray. Model number 272-700-000. For sterilization of Stryker Endoscopy arthroscopic…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Endoscopy
Matched: Brand · Product · Product details — STERRAD 100S parameters provided in the Shaver Handpiece reprocessing guide (P10299 Revision A) did not fully consider all worst-case scenarios…
FDA (openFDA device enforcement)
Reported May 14, 2014
12-Instrument Sterilization Tray; Product Usage: The 12-Instrument Tray is used to hold and protect surgical…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Endoscopy
Matched: Brand — Gravity sterilization parameters provided in the 12 Instrument Sterilization reprocessing guide did not fully consider all worst-case scenarios…
FDA (openFDA device enforcement)
Reported Oct 2, 2013
Stryker Vision Mounting Arm, for use with other Stryker Endoscopy medical device products for human patients. Model…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Endoscopy
Matched: Brand · Product · Product details — When positioning the display located on top of the video cart, it is possible for the user to apply excessive force and push the display up and out…
FDA (openFDA device enforcement)
Reported May 15, 2013
Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip, Vented, Metal Finish. Suction irrigator tips aid in cleaning…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Endoscopy
Matched: Brand · Product · Product details — The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct…
19 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 18, 2012
Stryker brand Arthroscope and Hardware Set Tray (sterilization tray); Model/Part Number: 233-032-116; Product is…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Endoscopy
Matched: Brand · Product · Product details — The gravity steam, Ethylene Oxide (EO) and STERRAD 100S sterilization methods are being removed from the "Instructions for Use"; due to the firm's…
FDA (openFDA device enforcement)
Reported Jul 4, 2012
Formula Shaver Handpiece (with buttons); Formula 180 Shaver Handpiece (with button) Rx only, Made USA.: Stryker…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Endoscopy
Matched: Brand · Product · Product details · Reason for recall — Stryker Endoscopy determined that there may not have been adequate determination of required routine checks to ensure accuracy and fitness for use of…
FDA (openFDA device enforcement)
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