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RecallWatchMedical Device Safety
Class IIOngoingZ-1804-2026

Stryker Sustainability Solutions recalls Stryker Sustainability Solution Color Cuff 24" (Yellow) Quick Connect Dual Port Single…

Stryker Sustainability SolutionsTempe, AZ, United StatesReported Apr 15, 2026 · 3 months ago
Legal News Analyst ·

Reason for recall

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • Stryker Sustainability Solution Color Cuff 24" (Yellow) Quick Connect Dual Port Single Bladder REF 5921-024-235 Stryker Sustainability Solution Color Cuff 18" (Red), Quick Connect Dual Port Single Bladder REF 5921-018-135 Stryker Sustainability Solution Color Cuff 18" (Red) Dual Port Single Bladder REF5921-018-235
    UDI-DI code
    400 affected lots
    00006084070000666479000071070500007484020000779936000080623400008231240000853520
    +392 more0001026721000119114000006105920000668978000071327400007504690000782278000080642400008231250000856167000102815300012040190000613383000067481400007169190000753840000078428800008071320000824757000087782000010332110001217956000061822200006790610000720023000075463300007876280000808365000082748800008783680001058134000122950800006283250000680520000072093300007557100000788773000080962900008298170000884047000107272300012316880000634780000068341700007262630000756541000079010600008112480000831661000088735500010802850001238396000064525900006879760000729862000075738900007904460000811740000083242700008990940001087139000124796000006470730000689032000073482500007590430000792153000081304900008333830000904725000110790700012486420000649426000069067000007369030000766311000079317800008134140000839160000093685000011095800000650589000069495800007405210000770116000079503000008164410000842177000095041900011177320000650994000069601200007418300000771335000079582600008182890000843424000095633700011185660000652336000069762600007426830000773128000079658700008198530000846088000097385100011584770000658811000069973300007450940000775812000080046100008206770000848208000098297000011631840000662208000070454000007467650000777690000080154700008216950000850631000099762200011719950000663506000070505400007477870000778370000080432000008227570000852419000101210200011886715921-018-235CONNECT-018-23550885825016062000060989900006505900000690671000072626400007634610000792154000081644300008403630001012101000117199600006105930000658812000069529700007274760000768855000079275200008182860000842180000102672200011886780000613711000066220900006960130000732858000077133600007958270000821298000084432700010295000001200103000062394500006664800000696720000073943800007731290000796588000082285200008465600001047460000122950900006261200000669025000069762700007404450000777026000079910500008262200000854710000106633800012479610000633577000067464300007034670000741831000077964500008025790000826374000087642600010794420001253084000063629200006755030000706848000074495300007832720000806235000082931800008889990001087140000125494000006387160000679066000070932800007514200000785086000080836300008298440000915425000110790800012595810000643088000068130300007125580000754295000078795700008092120000831758000093677500011142400000645991000068342700007171600000755547000078979300008125440000833100000094931500011185670000647074000068728500007200240000757390000079010700008159290000838765000098807700011584735921-024-235CONNECT-024-23550885825016116000060937800006588140000700579000074509700007822840000808367000083242600008890000001012100000120402100006105950000663505000070381600007461630000783274000080921400008328640000891969000102672300012180060000611745000066762500007054360000748057000078598400008112490000835176000090005600010281540001222644000061482200006726800000708327000074992800007867440000812293000083877400009069610001033218000123094000006181260000674644000071070400007542960000787958000081305000008421780000913984000105812400012479620000621163000067550500007125600000756186000078925700008135130000844340000092045500010663370001253080000062394700006790680000713835000075739100007901090000815931000084566900009242090001079438000125494200006254880000680521000071692100007582160000792155000081985500008465620000930032000108205800006291930000681987000072002600007634630000792754000082068000008487440000936882000108714100006327830000683415000072271100007701180000795825000082239600008506330000940957000110972800006347810000686675000072626500007713370000797234000082312800008522660000948040000111423700006420670000688508000072747700007731310000799971000082475500008535230000950415000114357500006452600000689009000073285900007758100000800826000082637600008548650000973852000115847800006475680000693830000073482400007776880000803213000082838200008564610000977519000117199700006506890000695724000073943900007786750000803622000082985700008783690000988075000117862400006549740000696014

What the firm is doing

On 03/12/2026, the firm sent via certified mail an "URGENT: Medical Device Recall" letter informing customers that there is a potential for Tourniquet Cuffs flange to detach from the bladder where the welding connection is, which may result in the cuff not able to maintain pressure. Customers are instructed to: 1. Inform individuals within their organization who need to be aware of this action. 2. Check their internal inventory to locate the affected product. Segregate the affected products, quarantine and discontinue use. 3. Complete the Business Reply Form (Attachment B) and return the completed via email to SSSPFA@stryker.com, or use the QR Code on Attachment B. Response is required. a. If customers have indicated that product remains in their inventory, a prepaid shipping label will be issued for the return of the product. Credit will be issued to their facility for products returned upon receipt. 4. Maintain awareness of this communication internally until all required actions have been completed within their facility. For any additional information or questions please reach out to SSSPFA@stryker.com or Stryker Customer Service at 800-624-4422.

DistributionShow details

U.S.: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NY, OHJ, OK, OR, PA SC, SD, TN, TX, VA, VT, and WA. O.U.S.: N/A

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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