Recall archive
121 recalls · page 2 of 6
Reported May 10, 2023
SafeLight Fiber Optic Cable: Clear, 5MM X 10FT 3.05M, REF: 0233-050-100; Gray, 5MM X 10FT 3.05M, REF: 0233-050-200
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Corporation
Matched: Brand — Fiber optic cables assembled with not enough epoxy on the proximal end, creating light output issues, which could cause a clinical delay or procedure…
FDA (openFDA device enforcement)
Reported Apr 12, 2023
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,1PRT QUICK Catalog number: 5921-030-135NS…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Corporation
Matched: Brand · Product · Product details — Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 22, 2023
Power-PRO 2 . Intended as an ambulance cot to transport a patient to or from an emergency or non-emergency location.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Medical Division
Matched: Brand — Transport Cot has insufficient volume of epoxy to assemblies installed in the head section and foot sectioning system may result in separation of…
FDA (openFDA device enforcement)
Reported Mar 8, 2023
Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 2L Catalog Number: FG 12010. Intended adjunct…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Corporation
Matched: Brand — Triton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output inaccurate blood loss estimates can lead to…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 21, 2022
Power-PRO 2, Model No. 6507, Item No. 650705550001 (US); 650700000000 (International)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Medical Division
Matched: Brand — Cot may experience unintended motion due to damaged cables. Potential risk of soft tissue injury to patients such as scrapes or bruises resulting…
FDA (openFDA device enforcement)
Reported Jul 27, 2022
Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Stryker Instruments Div.
Matched: Brand — Gauss Surgical is updating the Instructions for Use (IFU) for our Triton Sponge System in order to clarify proper technique for handling sponges and…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 16, 2022
1688 Camera Control Unit (CCU), Catalog number:1688010000. Used in general laparoscopy, nasopharyngoscopy, ear…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Corporation
Matched: Brand — A software defect in the camera control unit (CCU) will cause the image on the monitor to flip upside-down into an incorrect orientation. The…
FDA (openFDA device enforcement)
Reported Aug 18, 2021
Transport Stretcher 747 - a non-powered, wheeled device designed to support patients in a horizontal position, Part…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Medical Division
Matched: Brand — Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The…
18 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 21, 2021
Stryker, REF PC9001, PINPOINT Video Processor/Illuminator, Rx Only CE 0197, MD Medical Device, UDI: (01) 00858701006049…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Corporation
Matched: Brand · Product · Product details — Their is a potential that Video Processor/Illuminators may exhibit flickering, loss of image or unintended reboots.
FDA (openFDA device enforcement)
Reported Nov 18, 2020
Stryker Zyphr Disposable Cranial Perforator, Large 14/11 mm- is a sterile, single use cutting accessory intended for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Instruments Div.
Matched: Brand · Product · Product details — Potential for the inner bit to contain a crack, that may or may not be visible, which may lead to metal fragments entering the surgical site and/or…
FDA (openFDA device enforcement)
Reported Oct 7, 2020
Stryker IsoAir 2.0 support surface-provides pressure redistribution and is intended to assist in management of the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Medical Division
Matched: Brand · Product · Product details — Connector between support surface and pump may be out of tolerance resulting in difficulty in removing the CPR connector causing a delay in…
FDA (openFDA device enforcement)
Reported May 20, 2020
Stryker Power-PRO TL cot-powered ambulance cot Model Number 6550 - Product Usage: is a powered wheeled stretcher that…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Medical Division
Matched: Brand · Product · Product details — Ambulance Cots may not meet crash test standard BS EN 1789
FDA (openFDA device enforcement)
Reported May 13, 2020
Spy-Phi Drape (HH2000) sold as a Spy-Phi Pack (HH9006). Only sold in the US. Drape/ UDI: HH2000/10858701006329; HH9006/…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Corporation
Matched: Brand — Sterile drapes packaged in an unsealed pouch.
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 6, 2020
Neptune E-SEP 165mm Blade Electrode, Catalog Number 0703-165-001 - Product Usage: The Neptune E-SEP is an Integrated…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Instruments Div.
Matched: Brand — Due to a distribution error, product from the affected lot was shipped expired.
FDA (openFDA device enforcement)
Reported Mar 25, 2020
Stryker, REF: 0250070460, 5.0 mm x 32 cm, Strykeprobe, Outer Sheath Replacement, RX Only, Non-Sterile, CE, UDI: (01)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Corporation
Matched: Brand · Product · Product details — Potential diff. in the length of the sheath tube and the sheath/probe. A diff. in length could lead to the base of the sheath/probe not being fully…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 11, 2020
Stryker Connected OR Cart,120 V Ref Cat. #240-099-155, Qty 1, Rx Only, Manufactured for: Stryker, 5900 Optical Court,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Corporation
Matched: Brand · Product · Product details — There is a potential problem with firm s Connected OR Cart, 120V resulting in cart monitor not attaching flush with their monitor stow handle. The…
FDA (openFDA device enforcement)
Reported Feb 19, 2020
Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Double-Double, REF 3910-500-472, UDI 07613327464832, Sterile R,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Corporation
Matched: Brand · Product · Product details — Complaints have been received regarding difficulty in removing the driver from the screw. High driver removal forces can lead to the screw pulling…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 12, 2020
SafeAir Telescopic Smoke Evacuation Pencil, Product No. 0703 046 004. The product is a Bovie pencil that is 75 inches…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Instruments Div.
Matched: Brand — Hairline fractures in a component could allow electrical current to arc out of the device, resulting in a burn to the patient and/or user.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 11, 2019
Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 1PRT(Single Port) Quick Connect…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Instruments Div.
Matched: Brand · Product details — There is a potential for the cuff to leak air leading to a loss of vascular occlusion.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 9, 2019
C2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329 Product Usage: The C2 Nerve Monitor System is intended…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Instruments Div.
Matched: Brand · Reason for recall — Stryker C2 NerveMonitor's design and instructions may not optimally address usability issues related to the functionality of the device, which may…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 12, 2019
Stryker High Flow II Tube Set, REF 0620-040-660, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Corporation
Matched: Brand · Product · Product details — The heated tube sets were consistently leaking and detaching from the cassette.
2 more products in this recall
FDA (openFDA device enforcement)
Reported May 22, 2019
Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Medical Division
Matched: Brand — The power load floor plates which hold the ambulance cot anchors in place during patient transport, may be broken.
FDA (openFDA device enforcement)
Reported May 1, 2019
Performance Series Sagittal Blade, Catalog Number 6125-127-100 Product Usage: The Stryker Heavy Duty Sagittal Blades…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Instruments Div.
Matched: Brand · Product · Product details — During manufacture, packaging materials for a small portion of the lot may not have been properly positioned, resulting in a potential breach in…
FDA (openFDA device enforcement)
Reported Feb 13, 2019
Naera Hospital Bassinet, Model No. 4402
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Medical Division
Matched: Brand · Reason for recall — It was identified that the volume of air inside the mattress may expand in regions of high altitude which may result in an unintended gap between the…
FDA (openFDA device enforcement)
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