Stryker Sustainability Solutions recalls Stryker Sustainability Solution Color Cuff 24" (Yellow) Quick Connect Dual Port Single…
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 REF5921-018-235UDI-DI code400 affected lots00006084070000666479000071070500007484020000779936000080623400008231240000853520
+392 more
0001026721000119114000006105920000668978000071327400007504690000782278000080642400008231250000856167000102815300012040190000613383000067481400007169190000753840000078428800008071320000824757000087782000010332110001217956000061822200006790610000720023000075463300007876280000808365000082748800008783680001058134000122950800006283250000680520000072093300007557100000788773000080962900008298170000884047000107272300012316880000634780000068341700007262630000756541000079010600008112480000831661000088735500010802850001238396000064525900006879760000729862000075738900007904460000811740000083242700008990940001087139000124796000006470730000689032000073482500007590430000792153000081304900008333830000904725000110790700012486420000649426000069067000007369030000766311000079317800008134140000839160000093685000011095800000650589000069495800007405210000770116000079503000008164410000842177000095041900011177320000650994000069601200007418300000771335000079582600008182890000843424000095633700011185660000652336000069762600007426830000773128000079658700008198530000846088000097385100011584770000658811000069973300007450940000775812000080046100008206770000848208000098297000011631840000662208000070454000007467650000777690000080154700008216950000850631000099762200011719950000663506000070505400007477870000778370000080432000008227570000852419000101210200011886715921-018-235CONNECT-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 detailsHide
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
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1804-2026
- FDA device classification · KCYOfficial FDA classification for this device type
- CFR regulation · 21 CFR 878.5910The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Stryker Sustainability SolutionsSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
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 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.
More Class II recalls
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) BASIC PACK
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
- Eye Tray
- Nonconforming Material/Component
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) KIT
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
- Orthopedic Tray
- Nonconforming Material/Component
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 2
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
- Neurological Tray
- Nonconforming Material/Component