Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO
Medical device recall Z-0404-2016. Published in FDA’s Enforcement Report on Dec 16, 2015.
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 Dec 16, 2015. 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
- 174,960 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?
Sterilmed, Inc. is voluntarily recalling all unexpired Reprocessed Tourniquet Cuffs. Sterilmed cannot assure the sterility of all units in the recalled lots. The introduction of non-sterile product into a sterile operative field raises the risk of potential infection. Sterilmed has not received any reports of Adverse Events for this issue.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
174,960, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
All lot numbers with expiration dates 2016-07 or prior. Lot Number 1720009 1757854 1758629 1768646 1774412 1784664 1786626 1795911 1797605 1800714 1801676 1802271 1805472 1807344 1807744 1809011 1809184 1809195 1809910 1810063 1812006…
Every code shown here, 1,995 characters
All lot numbers with expiration dates 2016-07 or prior. Lot Number 1720009 1757854 1758629 1768646 1774412 1784664 1786626 1795911 1797605 1800714 1801676 1802271 1805472 1807344 1807744 1809011 1809184 1809195 1809910 1810063 1812006 1812312 1812365 1812545 1812561 1812567 1812740 1812883 1813141 1813511 1813959 1814040 1814199 1814219 1814223 1814231 1814651 1814671 1814751 1814989 1815220 1815362 1815371 1815416 1815427 1815591 1815611 1815908 1816182 1816186 1816268 1816269 1816511 1816512 1816513 1816514 1816516 1816558 1816719 1816734 1816737 1816761 1816851 1816853 1816854 1816856 1816858 1816862 1816864 1817011 1817012 1817026 1817043 1817044 1817054 1817056 1817171 1817172 1817181 1817182 1817187 1817194 1817215 1817221 1817229 1817244 1817273 1817275 1817276 1817362 1817368 1817370 1817371 1817377 1817378 1817387 1817388 1817389 1817390 1817391 1817392 1817394 1817396 1817398 1817401 1817403 1817407 1817408 1817412 1817447 1817449 1817450 1817516 1817523 1817532 1817539 1817558 1817559 1817560 1817563 1817564 1817581 1817603 1817606 1817608 1817611 1817686 1817687 1817692 1817696 1817699 1817700 1817710 1817736 1817737 1817742 1817743 1817748 1817749 1817750 1817760 1817773 1817778 1817786 1817791 1817795 1817826 1817828 1817839 1817840 1817842 1817843 1817859 1817868 1817880 1817885 1817912 1817939 1817943 1817948 1817950 1817953 1817962 1817988 1817999 1818005 1818006 1818008 1818034 1818037 1818039 1818069 1818076 1818080 1818088 1818089 1818098 1818101 1818113 1818114 1818115 1818161 1818162 1818165 1818171 1818209 1818213 1818226 1818228 1818229 1818255 1818256 1818265 1818266 1818267 1818268 1818287 1818295 1818301 1818305 1818306 1818324 1818325 1818332 1818336 1818337 1818341 1818357 1818358 1818373 1818378 1818380 1818396 1818398 1818402 1818403 1818410 1818411 1818412 1818426 1818429 1818430 1818435 1818438 1818454 1818460 1818472 1818477 1818478 1818484 1818485 1818529 1818531 1818551 1818562 1818568 1818569 1818572 1818575 1818600 1818603…
FDA’s list runs to 37,731 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.
US: Nationwide
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 Nov 13, 2015.
- FDA classified it on Dec 10, 2015.
- FDA’s Enforcement Report published it on Dec 16, 2015.
- FDA terminated it on Dec 12, 2016.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- STERILMED, INC., of Maple Grove, MN.
- 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 37,731 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.