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Lower risk Medical device recall · FDA · Published August 11, 2021

Cypress Medical: McKesson Lap Sponges with Sterilization Indicator Issue

Cypress Medical recalls McKesson Lap Sponges (12"x12", 5/pack) due to sterilization indicator not changing color as expected. Affected items have lot number CJJ12-07.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2473-2021Medical deviceCypress Medical ›
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Contact the company

Recalling firmCypress Medical Products LLC9954 Mayland Dr · Richmond, VA 23233-1464
✎ GovInfoNow plain-language explainer

Cypress Medical is recalling McKesson Lap Sponges that may not show the correct sterilization indicator. This could mean the sponges weren't properly sterilized, posing a risk of infection during medical procedures. Read more at govinfonow.com/recall/61959-cypress-medical-mckesson-lap-sponges-with-sterilization-indicator-issue.

Source Summary by GovInfoNow · govinfonow.com/recall/61959-cypress-medical-mckesson-lap-sponges-with-sterilization-indicator-issue · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2473-2021

Cite this page

“Cypress Medical: McKesson Lap Sponges with Sterilization Indicator Issue.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61959-cypress-medical-mckesson-lap-sponges-with-sterilization-indicator-issue. Based on FDA recall #Z-2473-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2473-2021%22&limit=1).

The FDA announced on 2021-08-11 that Cypress Medical Products LLC is recalling McKesson Lap Sponges due to a sterilization indicator failure. The hazard involves indicators not changing color as required, potentially leaving users unaware of non-sterile products.

How to tell if you have it

  • Brand: Cypress Medical
  • Product: McKesson Lap Sponge, X-Ray Detectable 12"x 12", 5/pack, Sterile
  • McKesson Part #: 16-2112121
  • Lot number: CJJ12-07
  • Quantity: 1 case (40 packs/cs)
  • Distribution: VA

The hazard

The recall is due to an EO indicator color issue where the indicator should change from red to blue to signify sterilization. However, on one case of product, the indicators did not change.

Context

GovInfoNow's records show Cypress Medical Products LLC has had 7 other recalls since 2017-11-17. Recent brand recalls include a 2024-08-20 BinaxNOW Strep A Test Kit recall for license purchase errors and a 2024-08-06 recall of 60mL syringes lacking FDA clearance. Other recent recalls of similar products include Medline Convenience Kits recalls from 2026-01-07 regarding contaminated sterilized products and calibration issues affecting sterility.

How to tell if you have this one

Check for the lot number CJJ12-07 on the packaging. The product is a sterile, 12"x12" lap sponge, 5 per pack, with McKesson Part # 16-2112121.

  • Brand
    Cypress Medical
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Sterilization Indicator

    Look for the indicator color change from red to blue. If it doesn't change, the sponge may not be properly sterilized.

Where it went and when

Where it was distributed

Distributed in Virginia.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: yesVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: not listedFL

FDA distribution: “VA” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Virginia.

Recall timeline

FDA terminated this recall 23 months after the firm started it.

1. Firm started the recall: Aug 11, 202112. FDA classified it Class II: Sep 14, 202123. Published in FDA’s Enforcement Report: Sep 22, 202134. FDA terminated the recall: Jul 7, 2023420212023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2473-2021 (August 11, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2473-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA