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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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 1527402743 1531400313 1531400683 1531503103 1526106313 1526603043 1526708133 1527402753 1531400323 1531400693 1531503113 1526106343 1526603053 1526708193 1527402763 1531400333 1531400703 1531503123 1526106363 1526603063 1526708203 1527402833 1531400343 1531400713 1531503133 1526106373 1526603073 1526708213 1527408173 1531400353 1531400723 1531503143 1526106423 1526603083 1526708223 1527408183 1531400363 1531400733 1531503153 1526106433 1526603093 1526708233 1527408193 1531400373 1531400743 1531503173 1526106493 1526603103 1526708253 1527408203 1531400383 1531400753 1531503183 1526106503 1526603113 1526708263 1531400023 1531400393 1531400763 1531503193 1526106513 1526603123 1526708283 1531400033 1531400403 1531400773 1531503203 1526106523 1526603133 1526708303 1531400043 1531400413 1531400783 1531503213 1526106583 1526603143 1526708313 1531400053 1531400423 1531400793 1531503233 1526602673 1526603153 1526708333 1531400063 1531400433 1531400803 1531503323 1526602683 1526603383 1526708343 1531400073 1531400443 1531400813 Stryker Product Number: 0694097001 Serial# 1533400133 1533400203 1532305563 1526809553 1531504263 1531504303 1531504293 1532305603 1532305583 1533400153 1533400173 1532305593 1527501963 1527502033 1527501973 1527502013 1533400143 1526809513 1526809523 1526809533 1526809543 1527501943 1527501983 1527502023 1531504273 1531504283 1527501953 1532305573
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Stryker Instruments Div. of Stryker Corporation
- Reason for Recall:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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.
Product Codes/Lot Numbers:
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 1527402743 1531400313 1531400683 1531503103 1526106313 1526603043 1526708133 1527402753 1531400323 1531400693 1531503113 1526106343 1526603053 1526708193 1527402763 1531400333 1531400703 1531503123 1526106363 1526603063 1526708203 1527402833 1531400343 1531400713 1531503133 1526106373 1526603073 1526708213 1527408173 1531400353 1531400723 1531503143 1526106423 1526603083 1526708223 1527408183 1531400363 1531400733 1531503153 1526106433 1526603093 1526708233 1527408193 1531400373 1531400743 1531503173 1526106493 1526603103 1526708253 1527408203 1531400383 1531400753 1531503183 1526106503 1526603113 1526708263 1531400023 1531400393 1531400763 1531503193 1526106513 1526603123 1526708283 1531400033 1531400403 1531400773 1531503203 1526106523 1526603133 1526708303 1531400043 1531400413 1531400783 1531503213 1526106583 1526603143 1526708313 1531400053 1531400423 1531400793 1531503233 1526602673 1526603153 1526708333 1531400063 1531400433 1531400803 1531503323 1526602683 1526603383 1526708343 1531400073 1531400443 1531400813 Stryker Product Number: 0694097001 Serial# 1533400133 1533400203 1532305563 1526809553 1531504263 1531504303 1531504293 1532305603 1532305583 1533400153 1533400173 1532305593 1527501963 1527502033 1527501973 1527502013 1533400143 1526809513 1526809523 1526809533 1526809543 1527501943 1527501983 1527502023 1531504273 1531504283 1527501953 1532305573
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1379-2016
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