Recall archive / FDA device enforcement
Color Cuff Single Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-135; Color Cuff Dual Port, Single... — FDA record Z-1315-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Mar 1, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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
- 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.
- Classification
- Class II
- Recalling firm
- Stryker Sustainability Solutions
- Quantity
- 127,894
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1315-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
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
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Apr 5, 2023
- Recall initiation date
- Mar 1, 2023
- Center classification date
- Mar 30, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.