Z-2101-2017Class II

White OR Towels, X-Ray Detectable, Sterile, 4 Towels per/pk; 20pk/Cs. Intended for packing and absorption...

Name: Z-2101-2017 White OR Towels, X-Ray Detectable, Sterile, 4 Towels per/pk; 20pk/Cs. Intended for packing and absorption...
Creator: Medical Action Industries Inc
Published: 2017-04-19
License: https://open.fda.gov/license/

Medical Action Industries, Inc. 306 / initiated 2017-04-19 / Open, Classified / root cause: sterility

FDA source

Medical Action Industries Inc began a recall of White OR Towels, X-Ray Detectable, Sterile, 4 Towels per/pk; 20pk/Cs. Intended for packing and absorption externally or within patient wounds in various... on 2017-04-19. FDA classified it as Class II and gives the reason as "Lint present on sterile Operating Room Towels". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-2101-2017
Classification: Class II
Status: Open, Classified
Initiated: 2017-04-19
Posted: 2017-05-17
Recalling firm: Medical Action Industries, Inc. 306
Product: White OR Towels, X-Ray Detectable, Sterile, 4 Towels per/pk; 20pk/Cs. Intended for packing and absorption externally or within patient wounds in various procedures or surgical cases.
Product code: GDY Gauze/Sponge, Internal, X-Ray Detectable
Reason for recall: Lint present on sterile Operating Room Towels.
Root cause tag: sterility
FDA root cause: Other
Action: Consignees were notified via Medical Device Notification of Recall notice on/about 4/19/2017.
Quantity in commerce: 69 cases
Distribution: AR, IN and NV.
Product codes and lots: Material Number: MSPT524, Lot #229445, Exp. Date: 10/12/2021.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2101-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2101-2017	Class II	Ongoing	Voluntary: Firm initiated	2017-05-24	2017-05-17
Z-2102-2017	Class II	Ongoing	Voluntary: Firm initiated	2017-05-24	2017-05-17

Product code GDY

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)