Z-0957-2019Class II

Curity All Purpose Sponges, Non-woven, 4 Ply, 4" x 4" (10.2 cm x 10.2 cm)

Name: Z-0957-2019 Curity All Purpose Sponges, Non-woven, 4 Ply, 4" x 4" (10.2 cm x 10.2 cm)
Creator: Cardinal Health 200, LLC
Published: 2018-12-27
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2018-12-27 / Terminated / root cause: sterility

FDA source

Cardinal Health 200, LLC began a recall of Curity All Purpose Sponges, Non-woven, 4 Ply, 4" x 4" (10.2 cm x 10.2 cm) Product Code: 8044 - Product Usage: Ideal for applying ointments, prepping, wiping... on 2018-12-27. FDA classified it as Class II and gives the reason as "Curity All Purpose Sponges were not sterilized and distributed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0957-2019
Classification: Class II
Status: Terminated
Initiated: 2018-12-27
Posted: 2019-02-26
Terminated: 2020-06-29
Recalling firm: Medtronic, Inc.
Product: Curity All Purpose Sponges, Non-woven, 4 Ply, 4" x 4" (10.2 cm x 10.2 cm) Product Code: 8044 - Product Usage: Ideal for applying ointments, prepping, wiping needles, cleaning slides and more Rayon/polyester blend construction Highly absorbent.
Product code: NAB Gauze / Sponge,Nonresorbable For External Use
Reason for recall: Curity All Purpose Sponges were not sterilized and distributed
Root cause tag: sterility
FDA root cause: Under Investigation by firm
Action: Cardinal Health issued Urgent: Medical Device Recall dated 12/27/18 advising of the problem and action to take: inspect segregate and return product. Return the acknowledgment form.The letter provides instructions to direct consignees to notify customers. Questions contact Cardinal Health at 800-292-9332
Quantity in commerce: 10,400 units (13 cases, 800 units/case)
Distribution: Worldwide distribution - US Nationwide and countries of Canada, Colombia.
Product codes and lots: Lot Number: 18E190262 Expiration Date: 05/2023

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0957-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0957-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-26

Product code NAB

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)