STRYKER CASSETTE PUMP, AHTO Tube Set, labeled sterile. Includes the following: a. Stryker AHT...

FDA Device Recall #Z-0836-2018 — Class II — November 17, 2017

Recall Summary

Recall Number Z-0836-2018
Classification Class II — Moderate risk
Date Initiated November 17, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Stryker Corporation
Location San Jose, CA
Product Type Devices
Quantity 60,753 units total

Product Description

STRYKER CASSETTE PUMP, AHTO Tube Set, labeled sterile. Includes the following: a. Stryker AHTO Tube Set Packaging (Model 0250070600); b. Stryker AHTO Tube Set with Tip Packaging (Model 0250070620);

Reason for Recall

Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.

Distribution Pattern

Distributed domestically to . Distributed internationally to Australia and Mexico.

Lot / Code Information

a. Model 0250070600, UDI 07613327061499, Lot No. 17284FG2, 17291FG2, 17300FG2; b. Model 0250070620, UDI 07613327061659, Lot No. 17275FG2, 17279FG2, 17280FG2, 17282FG2, 17283FG2, 17284FG2, 17285FG2, 17286FG2, 17289FG2, 17291FG2, 17292FG2, 17293FG2, 17297FG2, 17298FG2, 17299FG2;

Other Recalls from Stryker Corporation

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Z-0600-2026 Class II NICO Myriad Illumination Pack Product No. NN... Oct 31, 2025
Z-2277-2025 Class II Stryker SmartPump Tourniquet, disposable steril... Jul 2, 2025

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.