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
Read the official notice →- Date
- 2023-09-06
- Country
- United States
- Brand
- Stryker
- Product
- SurgiCount+ Software Application-indicated as an adjunctive technology for augmenting the manual process of counting, displaying and…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2023-11-15
US
Stryker Corporation recalls Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 1.5MM TIP, Catalog Number 6760-230-015
An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5 year) shelf life.
FDA · DeviceStryker CorporationUS Nationwide. Australia, Canada, Japan, Korea, Singapore.Official notice →- 2023-10-04
US
Stryker Corporation recalls Cinchlock SS Knotless Anchor Inserter, Part Number CAT02462
Expired Product distributed
FDA · DeviceStryker CorporationUS Nationwide distribution in the states of NY, NC, GA, TN, KY, IL, UT, AZ,…Official notice →- 2023-09-27
US
Stryker 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 →- 2023-05-10
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 →- 2023-04-12
US
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…
- 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…
Other drugs & medical recalls in the United States
- 2023-09-06
US
Smiths Medical ASD Inc. recalls PORTEX 0.5u HYDROPHOBIC DISC FILTER, REF 002291 - Bacterial/Viral filter
Smiths Medical identified a labeling error in which the barcode (UDI) was not correctly reflecting the expiration date of the product
US
Cardiac Assist, Inc recalls LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray part number: 5800-1000. Note: The 5800-1000…
Epoxy used during manufacturing of the LifeSPARC Pump may have uncured epoxy. if undetectable curing may result in added risk of early pump failure,
US
RAYSEARCH LABORATORIES AB recalls RayCare software, include version number 5A, 5B, 6A, including service packs-An oncology information system used to support workflows…
An issue was found in Software RayCare 5A, 5B, 6A, including service packs, where an allergy warning against medication substance (drug ingredient) will not be displayed as expected under certain circumstances
FDA · DeviceRAYSEARCH LABORATORIES ABUS Nationwide distribution in the state of TN.Official notice →US
Datascope Corp. recalls Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Users were identifying autofill failure conditions on the devices causing pump stops.
US
Datascope Corp. recalls Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33,…
Users were reporting instances of "Gas Loss in IAB Circuit" and "Gas Gain in IAB Circuit" alarms while providing therapy. An internal investigation of the complaints determined that there is a potential trigger for…
US
Datascope Corp. recalls Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33,…
Users reported "System Over Temperature" alarms associated with a loss of pumping and/or the Cardiosave system entering Standby mode.