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Lower risk Medical device recall · FDA · Published October 3, 2017

Degania Silicone Recall: Sterile Drain Pouches Missing Labels

Degania Silicone recalls sterile surgical drain pouches (JP-2234, Lot P16074: missing labels. This affects medical use. Contact for details.

🇺🇸 FDA recall #Z-0899-2018Medical deviceDegania Silicone ›
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Recalling firmDegania Silicone, Ltd.Degania Bet · Dganya Bet, Israel
✎ GovInfoNow plain-language explainer

What happened, in plain English

Degania Silicone is recalling sterile surgical drain pouches that lack labels. This could lead to incorrect use during medical procedures if the pouches aren't properly identified. Read more at govinfonow.com/recall/72918-degania-silicone-recall-sterile-drain-pouches-missing-labels.

Source Summary by GovInfoNow · govinfonow.com/recall/72918-degania-silicone-recall-sterile-drain-pouches-missing-labels · Updated September 17, 2026 · FDA enforcement record: FDA #Z-0899-2018

Cite this page

“Degania Silicone Recall: Sterile Drain Pouches Missing Labels.” GovInfoNow, updated September 17, 2026. https://govinfonow.com/recall/72918-degania-silicone-recall-sterile-drain-pouches-missing-labels. Based on FDA recall #Z-0899-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0899-2018%22&limit=1).

Why it’s dangerous

Missing labels on sterile pouches could cause healthcare workers to use the wrong product during surgery. This might lead to incorrect drainage or infection risks if the pouches aren't properly identified.

Who’s affected

Healthcare professionals using these drain pouches for surgical procedures. Patients undergoing surgery with this specific product are at risk if labels are missing.

How to tell if you have this one

Check for the catalog number JP-2234 and lot number P1607442 on the sterile pouches. The product is used for surgical drainage of body fluids.

  • Brand
    Degania Silicone
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Labels

    Look for the catalog number JP-2234 and lot number P1607442 on the pouches.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFLPuerto Rico: yesPR

FDA distribution: “US Distribution to Puerto Rico.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 3 years after the firm started it.

1. Firm started the recall: Oct 3, 201712. FDA classified it Class III: Mar 5, 201823. Published in FDA’s Enforcement Report: Mar 14, 201834. FDA terminated the recall: Oct 21, 2020420172020
  1. Firm started the recall
  2. FDA classified it Class III
  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-0899-2018 (October 3, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0899-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on September 17, 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.