Stryker Sustainability Solutions recalls Color Cuff Single Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-135; Color Cuff Dual Port, Single Bladder…
Increased incidence of disposable tourniquet cuffs "not able to achieve desired pressure" and "not holding pressure" due to 1) Cuff fabric tearing during use, and 2) Pinched or unseated O-ring at the connection between…
Read the official notice →- Date
- 2023-04-05
- Country
- United States
- Brand
- Stryker Sustainability Solutions
- Product
- Color Cuff Single Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-135; Color Cuff Dual Port, Single Bladder 30 (Royal…
- Classification
- Class II
- Units
- US: WI, MD, NY, PA, WA, CO, GA, FL, OH, NC, TX, NJ, OR, MT, CA, RI, SC, NE,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Sustainability Solutions recalls
- 2024-08-28
USStryker Sustainability Solutions recalls Disposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5A
Disposable 5 lead cable and lead wire system package that should contain lead systems, lead telemetry systems and a dual connect cable, may in fact contain, different ECG Leads, which are not approved for reprocessing,…
FDA · DeviceStryker Sustainability SolutionsUS Nationwide distribution in the states of FL, WY, AZ, CA, LA, TX, MI, OR,…Official notice →- 2024-07-24
- US
Stryker Sustainability Solutions recalls REF: 60-7070-005, Zimmer, Tourniquet Cuff 30" (Blue), Luer-Lock Dual Port, single Bladder, RxOnly
Mislabeling; tourniquet cuff packaging labeled as dual port single bladder but contains a tourniquet cuff single port single bladder.
FDA · DeviceStryker Sustainability SolutionsUS Nationwide distribution in the states of CA, CO, IL, MI, OR, WI.Official notice → - 2024-07-10
- US
Stryker Sustainability Solutions recalls Stryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter, REF: D134301, ELECTRODES: 22,…
Diagnostic electrophysiology (EP) catheters do not meet testing requirements.
FDA · DeviceStryker Sustainability SolutionsInternational distribution to the country of Japan.Official notice → - 2023-08-16
- US
Stryker Sustainability Solutions recalls HoverMatt, 39" W x 78" L, REF: HM39SPU-B
39-inche-wide inflatable air transfer mattress packages contain 34-Inch-wide mattresses, so there may be a decreased surface area available to distribute the patient's weight across, which may increase the effort…
FDA · DeviceStryker Sustainability SolutionsUS: WI, ID, CA, FL, HI, MD, RI, AZ, MA, GA, ILOfficial notice → - 2023-05-24
- US
Stryker Sustainability Solutions recalls REF 5065, Kendall, Impad Rigid Sole Foot Cover, Regular Pair ,<12", Rx Only Non-Sterile
Through complaint surveillance, it was identified that reprocessed Deep vein thrombosis (DVT) Compression Sleeves may be mislabeled and/or mispackaged.
- 2022-03-02
- US
Stryker Sustainability Solutions recalls REF: 5921-018-135, Stryker Color Cuff, 18" (Red), Quick Connect Single Port, Single Bladder
Mislabeling; dual-bladder tourniquet cuffs are labeled as single-bladder inflatable cuffs.
Other drugs & medical recalls in the United States
- 2023-04-05
- US
Covidien recalls COVIDIEN Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed REF 86051 7.0 mm I.D. The Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed are…
Due to potential leaks associate with the Oral/Nasal Tracheal Tube Cuffed inflation system.
FDA · DeviceCovidienU.S.: AK, AZ, CA, FL, GA, IA, IL, IN, KS MD, MI, MS, NC, NE, NJ, NY, OH, OK,…Official notice → - US
Limacorporate S.p.A recalls SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210
Shoulder glenoid fossa prosthesis was manufactured without tantalum markers so in the absence of the markers, on already implanted devices, a correct radiographic assessment of the hybrid glenoid position can be…
- US
Baxter Healthcare Corporation recalls Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.
The electrical safety testing was not properly performed on the impacted devices and additional testing is required
FDA · DeviceBaxter Healthcare CorporationUS distribution to AL, AR, AZ, FL, IL, ND, NY, OH, TX, WA.Official notice → - US
Fujifilm Irvine Scientific, Inc. recalls Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305
Due to the detection of oil toxicity in several lots of Oil for Embryo Culture products.
FDA · DeviceFujifilm Irvine Scientific, Inc.U.S.: AZ, AR, CA, CT, DC, FL, HI, IA, ID, IL, IN, KS, MA, MD, ME, MI, MN, MO,…Official notice → - US
Defibtech, LLC recalls DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on victims of sudden cardiac arrest
A component of a sub-assembly used in the affected AEDs had not undergone durability and reliability testing, and if a malfunction occurs, therefore the device could fail to deliver therapy.
- US
Siemens Medical Solutions USA, Inc recalls ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET table-A Fluoroscopic X-Ray system. Material #…
In the event of any unintended table movement, the system may not detect the incorrect direction, could lead to the injury of a patient, staff member, operator, or equipment.