Color Cuff Single Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-135; ...
FDA Device Recall #Z-1315-2023 — Class II — March 1, 2023
Recall Summary
| Recall Number | Z-1315-2023 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 1, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Stryker Sustainability Solutions |
| Location | Tempe, AZ |
| Product Type | Devices |
| Quantity | 127,894 |
Product Description
Color Cuff Single Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-135; Color Cuff Dual Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-235; Color Cuff Single Port, Single Bladder 34 (Purple), Quick Connect, REF: 5921-034-135; Color Cuff Dual Port, Single Bladder 34 (Purple), Quick Connect, REF: 5921-034-235; Color Cuff Single Port, Single Bladder 18 (Red), Quick Connect, REF: 5921-218-135; Color Cuff Dual Port, Single Bladder 18 (Red), Quick Connect, REF: 5921-218-235;
Reason for Recall
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 the cuff, disposable fill line, and/or cuff hosing, which may lead to loss of vascular occlusion, which may lead to operative site blood loss, hemorrhage, or other complications.
Distribution Pattern
US: WI, MD, NY, PA, WA, CO, GA, FL, OH, NC, TX, NJ, OR, MT, CA, RI, SC, NE, MI, LA, OK, SD, AL, VA, MS, WV, AZ, KY, IL, AR, ME, ND, MO, KS, HI, NH, AK, TN, IA, MN, IN, NV, MA, ID, DE, NM, WY, DC, VT, CT
Lot / Code Information
REF/UI-DI: 5921-030-135/885825016142, 5921-030-235/885825016166, 5921-034-135/885825016173, 5921-034-235/885825016197, 5921-218-135/885825016500, 5921-218-235/885825016296 Lots: 0000202775, 0000209215, 0000202137, 0000201380, 0000200708, 13872322, 13453772, 0000198235, 0000202066, 0000209420, 0000206425, 0000192978, 0000202577, 0000192465, 13463347, 0000204578, 0000193181, 0000198446, 0000208949, 0000195337, 0000206263, 0000193179, 13486613, 0000202777, 0000195071, 0000204159, 0000195912, 0000200905, 0000206442, 0000197869, 13594486, 0000192979, 0000200706, 0000195068, 0000201379, 0000199502, 0000199434, 0000188863, 13493683, 0000193177, 0000202065, 0000200712, 0000200242, 0000202138, 13582864, 0000195075, 13570832, 0000199808, 0000202075, 0000195340, 0000200254, 0000202932, 13774680, 13851472, 13634704, 0000199819, 0000204319, 0000204160, 0000201378, 0000200227, 0000203311, 0000206583, 13235119, 0000194243, 0000196364, 0000193841, 0000200270, 13828088, 0000196363, 13392486, 13280380, 0000192981, 0000198461, 0000196361, 0000200244, 0000203310, 0000200229, 13398036, 13352572, 0000194232, 0000200253, 0000198245, 0000202776, 0000197373, 0000187746, 13765829, 13449838, 0000200256, 0000202145, 0000198246, 0000198236, 0000204574, 0000202143, 0000194242, 13583025, 0000202074, 0000203315, 0000195073, 0000193176, 0000212764, 0000196379, 13811283, 13605685, 0000187310, 0000208444, 0000204366, 0000197867, 13865381, 13820702, 0000176566, 13663274, 0000196365, 0000210787, 0000206440, 0000193391, 0000201391, 0000193412, 0000177131, 13883084, 0000198460, 0000208345, 0000206443, 0000192466, 0000210962, 0000200230, 0000204570, 13339407, 0000204314, 0000211530, 0000209200, 0000196359, 0000210005, 0000201840, 0000205922, 0000192980, 0000205238, 0000195335, 0000206518, 0000195067, 0000203313, 0000193393, 0000206254, 0000208440, 0000202686, 0000198244, 0000203314, 0000195069, 0000208407, 0000206432, 13632837, 0000210465, 0000206505, 0000172873, 0000195338, 0000199805, 0000208321, 0000195343, 0000205241, 0000200707, 0000199807, 0000195076, 0000197375, 0000203312, 13870728, 0000202139, 0000206511, 0000193392, 13824462, 0000195070, 0000199816, 0000208410, 13871893, 0000199503, 0000206586, 13272167, 13399919, 0000195072, 0000199817, 0000192977, 0000197872, 0000186596, 0000208322, 13573489, 0000209992, 0000202684, 0000211154, 0000201837, 0000210310, 0000197870, 0000208606, 0000204571, 13883045, 0000197376, 0000194228, 0000204195, 0000198237, 0000212878, 0000209416, 0000210963, 0000210601, 0000200711, 0000194229, 0000204372, 0000196362, 13807840, 0000210008, 0000200228, 0000172314, 0000200257, 0000194230, 0000205930, 0000193839, 0000193178, 0000210313, 0000198459, 13814050, 0000202144, 0000193413, 0000195336, 13765599, 0000208951, 0000195078, 0000194227, 0000193838, 0000193840, 0000202778
Other Recalls from Stryker Sustainability Solutions
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0490-2026 | Class II | HARMONIC FOCUS Shears + Adaptive Tissue Technol... | Sep 24, 2025 |
| Z-2689-2024 | Class II | Disposable 5 Lead Cable and Lead Wire System, 5... | Jul 2, 2024 |
| Z-2405-2024 | Class II | REF: 60-7070-005, Zimmer, Tourniquet Cuff 30" (... | May 31, 2024 |
| Z-2268-2024 | Class II | Stryker Sustainability Solutions, BW Lasso 2515... | May 10, 2024 |
| Z-2394-2023 | Class II | HoverMatt, 39" W x 78" L, REF: HM39SPU-B | Jun 21, 2023 |
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.