Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs…
Medical device recall Z-0324-2017. Published in FDA’s Enforcement Report on Nov 9, 2016.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Nov 9, 2016. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 1,695,760 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Issue with the process for detection of leaking Pressure Tourniquet Cuffs (PTC). Leaking PTC devices may result in excessive blood loss requiring surgical or medical intervention or systemic leakage of local anesthetic during Bier Block requiring medical intervention.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.
1,695,760, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model Lot Lot Created Expiration 5921-018-135 2990595 5/5/2014 May-16 5921-018-235 2989898 5/5/2014 May-16 5921-018-235 2992868 5/5/2014 May-16 5921-024-235 2992501 5/5/2014 May-16 5921-030-135 2990147 5/5/2014 May-16 5921-030-135 2991575…
Every code shown here, 1,993 characters
Model Lot Lot Created Expiration 5921-018-135 2990595 5/5/2014 May-16 5921-018-235 2989898 5/5/2014 May-16 5921-018-235 2992868 5/5/2014 May-16 5921-024-235 2992501 5/5/2014 May-16 5921-030-135 2990147 5/5/2014 May-16 5921-030-135 2991575 5/5/2014 May-16 5921-030-235 2993033 5/5/2014 May-16 5921-034-135 2990152 5/5/2014 May-16 5921-034-135 2992555 5/5/2014 May-16 5921-034-235 2989674 5/5/2014 May-16 5921-034-235 2990240 5/5/2014 May-16 5921-034-235 2991095 5/5/2014 May-16 5921-034-235 2991413 5/5/2014 May-16 5921-034-235 2993046 5/5/2014 May-16 5921-034-235 2993509 5/5/2014 May-16 5921-218-235 2990217 5/5/2014 May-16 5921-218-235 2990553 5/5/2014 May-16 5921-218-235 2991743 5/5/2014 May-16 5921-218-135 2990106 5/5/2014 May-16 5921-218-135 2992540 5/5/2014 May-16 60-7070-102 2990697 5/5/2014 May-16 60-7070-103 2984111 5/5/2014 May-16 60-7070-103 2989473 5/5/2014 May-16 60-7070-103 2990110 5/5/2014 May-16 60-7070-103 2991030 5/5/2014 May-16 60-7070-103 2992398 5/5/2014 May-16 60-7070-103 2992636 5/5/2014 May-16 60-7070-105 2989822 5/5/2014 May-16 60-7070-105 2990012 5/5/2014 May-16 60-7070-105 2991271 5/5/2014 May-16 60-7070-105 2993392 5/5/2014 May-16 60-7070-104 2992643 5/5/2014 May-16 60-7070-106 2990433 5/5/2014 May-16 60-7070-106 2991817 5/5/2014 May-16 60-7070-106 2993407 5/5/2014 May-16 60-7075-004 2989867 5/5/2014 May-16 60-7075-103 2990650 5/5/2014 May-16 60-7075-103 2991432 5/5/2014 May-16 60-7075-103 2992627 5/5/2014 May-16 60-7075-105 2992282 5/5/2014 May-16 60-7075-106 2990451 5/5/2014 May-16 60-7075-106 2990958 5/5/2014 May-16 5921-018-135 2996601 5/8/2014 May-16 5921-024-135 2996808 5/8/2014 May-16 5921-030-235 2995775 5/8/2014 May-16 5921-030-235 2998064 5/8/2014 May-16 5921-034-135 2996324 5/8/2014 May-16 5921-034-235 2994193 5/8/2014 May-16 5921-034-235 2995233 5/8/2014 May-16 5921-034-235 2996975 5/8/2014 May-16 5921-218-235 2994186 5/8/2014 May-16 5921-218-235 2996503 5/8/2014 May-16 5921-218-235 2997742 5/8/2014 May-16 5921-218-135 2996590…
FDA’s list runs to 563,955 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
U.S. distribution nationwide. No foreign distribution
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Sep 19, 2016.
- FDA classified it on Oct 28, 2016.
- FDA’s Enforcement Report published it on Nov 9, 2016.
- FDA terminated it on Jun 1, 2017.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Stryker Sustainability Solutions, of Tempe, AZ.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 563,955 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.