Z-0772-2023Class II

Pilling Wecksorb Cylindrical Sponges

Name: Z-0772-2023 Pilling Wecksorb Cylindrical Sponges
Creator: Teleflex Llc
Published: 2022-09-28
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2022-09-28 / Open, Classified / root cause: manufacturing process

FDA source

TELEFLEX LLC began a recall of Pilling Wecksorb Cylindrical Sponges on 2022-09-28. FDA classified it as Class II and gives the reason as "Specific lots have not been irradiated to eliminate pyronema and therefore the sterility of the affected products may be compromised". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0772-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-09-28
Posted: 2022-12-28
Recalling firm: Teleflex Medical
Product: Pilling Wecksorb Cylindrical Sponges
Product code: EFQ Gauze/Sponge, Internal
Reason for recall: Specific lots have not been irradiated to eliminate pyronema and therefore the sterility of the affected products may be compromised.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Consignees were notified on about 09/28/2022, via letter. Consignees were instructed to immediately discontinue use and quarantine the products on hand, complete and return the enclosed Acknowledgement Form via fax to 1-855-419-8507 or email to [email protected]. A customer service representative will contact you with a Return Goods Authorization (RGA) number and provide instructions for the return of products.
Quantity in commerce: 1,000 units
Distribution: Domestic distribution to IL, MS, PA, TN.
Product codes and lots: Catalog Number: 200400, Lot Number: 22B0395

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0772-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0772-2023	Class II	Terminated	Voluntary: Firm initiated	2023-01-04	2022-12-28

Product code EFQ

K791871UnclassifiedNeurological Sponges (Patties)Carwild Corp. / cleared 1979-11-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)