Stryker Sustainability Solutions recalls BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007
Diagnostic electrophysiology (EP) catheter may have a breached sterile barrier on the straight seal side of the primary pouch, which if used could lead to particulate embolization, infection, thrombus or ganuloma…
Read the official notice →- Date
- 2026-10-14
- Country
- United States
- Brand
- Stryker Sustainability Solutions
- Product
- BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007
- Classification
- Class II
- Units
- US Nationwide distribution in the state of NJ.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2026-09-23
USStryker Sustainability Solutions recalls REF:2B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 75MM
Reusable access port system may crack or seperate during use.
FDA · DeviceStryker Sustainability SolutionsUS Nationwide distribution including in the states of Alabama, Alaska,…Official notice →- 2026-05-20
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Stryker Sustainability Solutions recalls BARD Dynamic Tip Steerable, Product Number 6DYNTP001;
Incomplete seals on sterile product
FDA · DeviceStryker Sustainability SolutionsUS Nationwide and the countries of Israel and Canada.Official notice → - 2026-04-15
- US
Stryker Sustainability Solutions recalls Stryker Sustainability Solution Color Cuff 24" (Yellow) Quick Connect Dual Port Single Bladder REF 5921-024-235 Stryker…
Due to potential for tourniquet cuffs to detach from the bladder at the welding connection and result in the cuff not being able to maintain pressure.
FDA · DeviceStryker Sustainability SolutionsU.S.: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA,…Official notice → - 2025-11-19
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Stryker Sustainability Solutions recalls HARMONIC FOCUS Shears + Adaptive Tissue Technology, 9 cm Length REF: HAR9F, Reprocessed Device for Single Use, STERILEEO, RX ONLY
Due to manufacturing issue, reprocessed shears, may become stuck in the "on position" resulting in continuous activation.
FDA · DeviceStryker Sustainability SolutionsUS Nationwide distribution and OUS (foreign) to country of: Canada.Official notice → - 2024-08-28
- US
Stryker 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 →
Other drugs & medical recalls in the United States
- 2026-10-14
- US
Nihon Kohden America LLC recalls Product Name: Nihon Kohden CNS-6200 Series Central Nurse Station, Model/Catalog Number: CN-6201 Software Version: software versions:…
Due to a cybersecurity issue associate with a NULL Pointer Dereferences vulnerabiity. If exploited would potentially cause disruption of the centralized monitoring of multiple beds and the visualization of alarms.
FDA · DeviceNihon Kohden America LLCUS Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT,…Official notice → - US
Medtronic MiniMed, Inc. recalls Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin Pump Model/Catalog Numbers: MMT-8062; MMT-8072 Product Description: The…
Some MiniMed Flex insulin pumps were released with missing (i.e., devices with no result or abort test results are presumed to have failed) or failed verification test results in one or more of 9 functional tests. The…
FDA · DeviceMedtronic MiniMed, Inc.U.S. Nationwide distribution in the states of AR, AZ, CO, FL, KS, KY, LA, MI,…Official notice → - US
Medline Industries, LP recalls Rollator, Bariatric, Basic Steel, Blue, mechanical walker with four legs and a metal frame intended for medical purposes to provide…
The front fork stem bolt/wheel assembly may disconnect from the rollator frame tubing. If the front fork stem bolt/wheel assembly disconnects from the rollator frame tubing, the front wheels may become loose or detach…
FDA · DeviceMedline Industries, LPWorldwide distribution - US Nationwide and the country of Canada.Official notice → - US
Beckman Coulter Inc. recalls DxC 500 AU Clinical Chemistry Analyzers: 1. AU w/out ISE, Part No. C63519 2. AU w/ISE, Part No. C63520
Beckman Coulter has identified a software issue affecting DxC 500 AU Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical Chemistry test to use units different from the system…
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Beckman Coulter Inc. recalls DxC 500i Clinical Analyzer Modules: 1. DxC 500 AU Module w/ISE, DxC 500i, Part No. C63522 2. DxC 500 AU Module, DxC 500i, Part No. C63521…
Beckman Coulter has identified a software issue affecting DxC 500i Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical Chemistry test to use units different from the system…
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DRG International, Inc. recalls Sperm Ab ELISA; Model/Catalog Number: EIA-1826; Product Description: Sperm Ab ELISA (96 well plate test);
Potential for false negative patient results.
FDA · DeviceDRG International, Inc.Worldwide - US Nationwide distribution in the state of NJ and the countries of…Official notice →