Stryker Corporation recalls Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,1PRT QUICK Catalog number: 5921-030-135NS Indicated for use…
Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the cuff onto the patient, may lead to operative site blood…
Read the official notice →- Date
- 2023-04-12
- Country
- United States
- Brand
- Stryker
- Product
- Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,1PRT QUICK Catalog number: 5921-030-135NS Indicated for use…
- Classification
- Class II
- Units
- US Nationwide distribution.
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Stryker recalls
- 2023-09-27
USStryker Corporation recalls Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle-Allows the user to mix bone cement witha constant high…
Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the potential for loss of function of the ACM system and…
FDA · DeviceStryker CorporationNationwide Foreign: Austria Belgium Canada France Germany Hong Kong Italy…Official notice →- 2023-09-06
- US
Stryker Corporation recalls SurgiCount+ Software Application-indicated as an adjunctive technology for augmenting the manual process of counting, displaying and…
Potential for current software to miscount when scanning in multiple sponge-products from the same unique sponge-pack type
- 2023-05-10
- US
Stryker Corporation recalls SafeLight Fiber Optic Cable: Clear, 5MM X 10FT 3.05M, REF: 0233-050-100; Gray, 5MM X 10FT 3.05M, REF: 0233-050-200
Fiber optic cables assembled with not enough epoxy on the proximal end, creating light output issues, which could cause a clinical delay or procedure being converted to open.
FDA · DeviceStryker CorporationWorldwide - US Nationwide distribution including in the states of PA, MS, IL,…Official notice → - 2023-03-08
- US
Stryker GmbH recalls stryker Hoffmann LRF, Transport Strut, Model Number 4933-0-400; Orthopedic external fixation device intended to keep bone…
Stryker has identified a nonconformance in specific lots of Hoffmann LRF Bone Transport Struts. Specifically, the thread pitch is oversized at the distal end of the threaded rod, and as a result the distal ring…
- US
Stryker Corporation recalls Triton Canister Software Catalog Number: GAUS-2. Intended adjunct in the estimation of blood loss.
Triton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output inaccurate blood loss estimates can lead to confusion and could potentially result in either delayed recognition or…
- 2022-05-04
- US
Stryker GmbH recalls Smart Toe II Intramedullary Arthrodesis Implant
The nickel-sensitivity statement on the outer carton may be partially covered by a label resulting in the statement showing "Indicated for patients with Nickel sensitivity" instead of "Not Indicated for patients with…
FDA · DeviceStryker GmbHWorldwide distribution - US Nationwide and the countries including Australia,…Official notice →
Other drugs & medical recalls in the United States
- 2023-04-12
- US
Abbott Molecular, Inc. recalls Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.
The instrument was found to be installed without plunger assemblies in the clamp bar for an Amplification Detection Unit. After correction of the issue, the instrument was returned for use without calibration. This…
FDA · DeviceAbbott Molecular, Inc.US Distribution to state of: PA, a government account.Official notice → - US
CooperSurgical, Inc. recalls Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and transfer, Reference Number H5GT-060
It has come to CooperSurgical's attention that the affected Product may contain a medium other than the Global Total LP single step medium which does not contain the protein source required for embryo culture and…
FDA · DeviceCooperSurgical, Inc.Worldwide - US Nationwide distribution in the states of NY, UT and the…Official notice → - US
Terumo Cardiovascular Systems Corporation recalls CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE
Some Capiox NX, RX and FX Oxygenators may contain an arterial thermistor component that is improperly bonded to the oxygenator port. This may result in a leak at the point where the arterial thermistor is improperly…
FDA · DeviceTerumo Cardiovascular Systems CorporationUS Nationwide. Belgium, Canada, Costa Rica, Thailand.Official notice → - US
Moberg Research, Inc. recalls Moberg Component Neuromonitoring System (CNS Monitor)-Intended as a short-term neurological monitoring system that collects, displays, and…
Battery leakage can cause corrosion to the metal enclosure near the electrical interface. Prolonged contact to corrosive materials could cause injury to skin. DOC
FDA · DeviceMoberg Research, Inc.Worldwide distribution - US Nationwide and the countries of France, Germany,…Official notice → - US
Maquet Cardiovascular, LLC recalls VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System, Model Number C-VH-4000
Some batches of product were not sterilized to their minimum sterilization specification.
FDA · DeviceMaquet Cardiovascular, LLCWorldwide distribution - US Nationwide and the countries of Brazil, China.Official notice → - US
Medtronic Sofamor Danek USA Inc recalls Medtronic Grafton DBF Inject: a) GRAFTON T50303 DBF INJECT 3CC, REF T50303; b) GRAFTON T50306 DBF INJECT 6CC, REF T50306; c)…
Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.
FDA · DeviceMedtronic Sofamor Danek USA IncWorldwide distribution - US Nationwide and the countries of Australia,…Official notice →