Color CuffRecalls & reported problems across all models
Stryker Corporation · 25 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
7 open recalls name at least one Color Cuff model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 193
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 9
We found 25 models of Color Cuff by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 193 adverse event reports in the FDA's MAUDE database, received between Jun 25, 2018 and Sep 30, 2026 — classified as 193 malfunctions.
The most frequently reported specific device problem is “Decrease in Pressure” (179 reports).
9 FDA recall records name at least one of these models by its device identifier, 7 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Color Cuff recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jul 2, 2025Open, Classified
Tourniquet cuff flange may become detached from the bladder. If leak occurs during the procedure, there may be risk of hemorrhage, resulting in blood loss greater than expected. Other serious risks include cerebral hypotension and cardiovascular collapse and arrest, risking stroke or death. Specific to IVRA, patient toxicity may also occur due to rapid systemic absorption of anesthetics.
Z-2277-2025 · Root cause: Equipment maintenance · names 3 of these models · Recall details · FDA record ↗
- Mar 1, 2023Open, Classified
Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the cuff onto the patient, may lead to operative site blood loss, hemorrhage or, in exceedingly rare situations, other major complications
Z-1344-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Mar 1, 2023Open, Classified
Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the cuff onto the patient, may lead to operative site blood loss, hemorrhage or, in exceedingly rare situations, other major complications
Z-1343-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Mar 1, 2023Open, Classified
Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the cuff onto the patient, may lead to operative site blood loss, hemorrhage or, in exceedingly rare situations, other major complications
Z-1342-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Mar 1, 2023Open, Classified
Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the cuff onto the patient, may lead to operative site blood loss, hemorrhage or, in exceedingly rare situations, other major complications
Z-1341-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Mar 1, 2023Open, Classified
Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the cuff onto the patient, may lead to operative site blood loss, hemorrhage or, in exceedingly rare situations, other major complications
Z-1340-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Mar 1, 2023Open, Classified
Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the cuff onto the patient, may lead to operative site blood loss, hemorrhage or, in exceedingly rare situations, other major complications
Z-1339-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Nov 6, 2019Terminated
There is a potential for the cuff to leak air leading to a loss of vascular occlusion.
Z-0593-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Nov 6, 2019Terminated
There is a potential for the cuff to leak air leading to a loss of vascular occlusion.
Z-0592-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported Color Cuff problems
Device problems
- Decrease in Pressure179
- Gas/Air Leak5
- Leak/Splash4
- Pressure Problem3
- Material Puncture/Hole2
- Device Alarm System1
- Device Contaminated During Manufacture or Shipping1
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions158
- No Consequences Or Impact To Patient29
- Insufficient Information11
- No Known Impact Or Consequence To Patient5
- No Patient Involvement5
- Burn(s)1
- Tissue Breakdown1
Color Cuff models
25 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Color Cuff 5921018135TOURNIQUET, PNEUMATIC2 recalls31 reports
- Color Cuff 5921018235TOURNIQUET, PNEUMATIC2 recalls20 reports
- Color Cuff 5921-034-135NSTOURNIQUET, PNEUMATIC1 recall20 reports
- Color Cuff 5921-030-135NSTOURNIQUET, PNEUMATIC1 recall14 reports
- Color Cuff 5921024235TOURNIQUET, PNEUMATIC1 recall5 reports
- Color Cuff 5921-218-135NSTOURNIQUET, PNEUMATIC1 recall5 reports
- Color Cuff 5921-034-235NSTOURNIQUET, PNEUMATIC1 recall3 reports
- Color Cuff 5921-218-235NSTOURNIQUET, PNEUMATIC1 recall2 reports
- Color Cuff 5921-030-235NSTOURNIQUET, PNEUMATIC1 recall1 report
- Color Cuff 5921034235TOURNIQUET, PNEUMATIC21 reports
- Color Cuff 5921030235TOURNIQUET, PNEUMATIC13 reports
- Color Cuff 5921034135TOURNIQUET, PNEUMATIC13 reports
- Color Cuff 5921218135TOURNIQUET, PNEUMATIC10 reports
- Color Cuff 5922030135TOURNIQUET, PNEUMATIC9 reports
- Color Cuff 5921030135TOURNIQUET, PNEUMATIC8 reports
- Color Cuff 5921218235TOURNIQUET, PNEUMATIC5 reports
- Color Cuff 5922044135TOURNIQUET, PNEUMATIC3 reports
- Color Cuff 5921212235TOURNIQUET, PNEUMATIC2 reports
- Color Cuff 5922034235TOURNIQUET, PNEUMATIC2 reports
- Color Cuff 5921034136TOURNIQUET, PNEUMATIC1 report
- Color Cuff 5921044135TOURNIQUET, PNEUMATIC1 report
- Color Cuff 5921044235TOURNIQUET, PNEUMATIC1 report
- Color Cuff 5921218136TOURNIQUET, PNEUMATIC1 report
- Color Cuff 5922024135TOURNIQUET, PNEUMATIC1 report
- Color Cuff 5922218135TOURNIQUET, PNEUMATIC1 report
Recent Color Cuff adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Decrease in Pressure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946351 ↗MalfunctionMay 29, 2026Decrease in Pressure
IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY THE TOURNIQUET EXPERIENCED A LEAK. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE USER FACILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25330685 ↗MalfunctionMay 15, 2026Fracture
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY A CRACK WAS OBSERVED ON THE TOURNIQUET CUP. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25185301 ↗MalfunctionMar 26, 2026Decrease in Pressure
IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY THE TOURNIQUET WOULD NOT STAY INFLATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24697252 ↗MalfunctionMar 25, 2026Decrease in Pressure
IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY TWO TOURNIQUETS TEARING AT THE SEAMS AND NOT HOLDING PRESSURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24690846 ↗MalfunctionMar 25, 2026Decrease in Pressure
IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY TWO TOURNIQUETS TEARING AT THE SEAMS AND NOT HOLDING PRESSURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24690660 ↗MalfunctionJan 16, 2026Decrease in Pressure
IT WAS REPORTED THAT THE CUFF DEVICE WAS UP FOR 10 MINUTES THEN DEFLATED. THEY CHECKED CONNECTIONS AND REINFECTED THE CUFF BUT THEN THE ALARM WENT OFF. THEY HEARD A LEAK ALONG THE SEAM OF THE CUFF. DURING A PROCEDURE AT THE USER FACILITY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24099197 ↗MalfunctionNov 13, 2025Decrease in Pressure; Decrease in Pressure
IT WAS REPORTED THAT THE DEVICE LEAKING AIR DURING A PROCEDURE AT THE USER FACILITY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23543180 ↗MalfunctionAug 4, 2025Decrease in Pressure; Decrease in Pressure
IT WAS REPORTED THAT DURING TAKING BLOOD PRESSURE THE DEVICE WOULD NOT INFLATE AT THE USER FACILITY. ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE USER FACILITY.
Patient problems: Insufficient Information
MAUDE report 22707247 ↗MalfunctionJul 29, 2025Decrease in Pressure; Decrease in Pressure
IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY WITH MENISCECTOMY SURGERY, THE DEVICE WOULD NOT INFLATE DURING A PROCEDURE AT THE USER FACILITY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22649695 ↗MalfunctionJul 22, 2025Leak/Splash
WHEN WE WENT TO INFLATE THE TOURNIQUET, THE TOURNIQUET WAS LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22564385 ↗MalfunctionJul 10, 2025Decrease in Pressure; Decrease in Pressure
IT WAS REPORTED THAT THE DEVICE LEAKING AIR DURING A PROCEDURE AT THE USER FACILITY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY. NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22467460 ↗MalfunctionJun 11, 2025Decrease in Pressure; Decrease in Pressure
IT WAS REPORTED THAT THE DEVICE IS NOT HOLDING PRESSURE DURING A PROCEDURE AT THE USER FACILITY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22185516 ↗MalfunctionJun 11, 2025Decrease in Pressure; Decrease in Pressure
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22185515 ↗MalfunctionJun 11, 2025Decrease in Pressure; Decrease in Pressure
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22183233 ↗
Other Stryker Corporation products
- RemB7 models · 3,073 reports
- Prime Series21 models · 1,548 reports · 2 recalls
- TARGET114 models · 1,077 reports
- ProCuity17 models · 368 reports · 13 recalls
- Spetzler-Malis20 models · 7 reports · 19 recalls
- SYNCHRO 28 models · 313 reports · 9 recalls
- Neptune E-SEP19 models · 412 reports · 7 recalls
- StrykeFlow4 models · 552 reports · 4 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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