SurgiCounter scanner, part of the SurgiCount Safety-Sponge System
Medical device recall Z-1379-2016. Published in FDA’s Enforcement Report on Apr 20, 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 Apr 20, 2016. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 21 states named
- 286 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?
The affected scanner does not correctly interact with the SC360 software. When docked pre/postoperatively, the affected SurgiCounter scanner may display an error message (code=2). Also, the SurgiCounter scanner software version number is not appropriately displayed in the SC360 application during installation.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
SurgiCounter scanner, part of the SurgiCount Safety-Sponge System. Model numbers 0694-097-000 and 0694-097-001. Product Usage: The SurgiCount Safety Sponge System is indicated for use in counting and recording the number of thermally labeled surgical sponges, laparotomy sponges, and towels used during surgical procedures.
286, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model Number(s): 0694-097-000 0694-097-001 Units individually serialized, SN numbers included in recall Letter. Units distributed 11/1/2015-12/17/2015 Stryker Product Number: 0694097000 Serial# 1525901643 1526602693 1526603463 1526708353…
Every code shown here, 2,000 characters
Model Number(s): 0694-097-000 0694-097-001 Units individually serialized, SN numbers included in recall Letter. Units distributed 11/1/2015-12/17/2015 Stryker Product Number: 0694097000 Serial# 1525901643 1526602693 1526603463 1526708353 1531400083 1531400453 1531400823 1525901653 1526602713 1526603473 1526708393 1531400093 1531400463 1531400833 1525901663 1526602723 1526603483 1526708403 1531400103 1531400473 1531400843 1525901673 1526602733 1526603493 1526708413 1531400113 1531400483 1531400853 1525901683 1526602743 1526603503 1526708423 1531400123 1531400493 1531400863 1525901693 1526602753 1526603513 1526708443 1531400133 1531400503 1531400873 1525901703 1526602863 1526603523 1526708463 1531400143 1531400513 1531400883 1525901713 1526602873 1526603533 1526708473 1531400153 1531400523 1531400893 1525901723 1526602883 1526603543 1526708493 1531400163 1531400533 1531400903 1525901733 1526602893 1526603553 1526708503 1531400173 1531400543 1531400913 1526106133 1526602903 1526603563 1526708523 1531400183 1531400553 1531400923 1526106143 1526602913 1526603573 1526708533 1531400193 1531400563 1531400933 1526106153 1526602923 1526603583 1526708543 1531400203 1531400573 1531400943 1526106163 1526602933 1526603593 1526708563 1531400213 1531400583 1531400953 1526106173 1526602943 1526603603 1526708573 1531400223 1531400593 1531400963 1526106183 1526602953 1526603613 1526708583 1531400233 1531400603 1531400973 1526106193 1526602963 1526603623 1527101333 1531400243 1531400613 1531400983 1526106203 1526602973 1526603633 1527207393 1531400253 1531400623 1531400993 1526106213 1526602983 1526603643 1527207413 1531400263 1531400633 1531401003 1526106223 1526602993 1526603653 1527207523 1531400273 1531400643 1531503063 1526106233 1526603003 1526708093 1527402703 1531400283 1531400653 1531503073 1526106243 1526603013 1526708103 1527402723 1531400293 1531400663 1531503083 1526106293 1526603023 1526708113 1527402733 1531400303 1531400673 1531503093 1526106303 1526603033 1526708123…
FDA’s list runs to 3,386 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 Distribution in the states of AR, AZ, CA, CT, FL, GA, IN, LA, MD, MN, MO, MS, NJ, NM, NY, OH, SC, SD, TN, TX and UT.
The states and territories these words name
21 states and territories.
Every one of them
- Arkansas
- Arizona
- California
- Connecticut
- Florida
- Georgia
- Indiana
- Louisiana
- Maryland
- Minnesota
- Missouri
- Mississippi
- New Jersey
- New Mexico
- New York
- Ohio
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
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 Mar 21, 2016.
- FDA classified it on Apr 13, 2016.
- FDA’s Enforcement Report published it on Apr 20, 2016.
- FDA terminated it on Sep 6, 2016.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Stryker Instruments Div. of Stryker Corporation, of Portage, MI.
- 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 3,386 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.