Z-2250-2023Class II

Equipment and table drapes: (1) Ecolab Banded Bag with Rubberband and Tape, 91 cm x 51 cm (36 in x 20 in)...

Name: Z-2250-2023 Equipment and table drapes: (1) Ecolab Banded Bag with Rubberband and Tape, 91 cm x 51 cm (36 in x 20 in)...
Creator: Microtek Medical Inc.
Published: 2023-06-23
License: https://open.fda.gov/license/

Microtek Medical LLC / initiated 2023-06-23 / Open, Classified

FDA source

Microtek Medical Inc. began a recall of Equipment and table drapes: (1) Ecolab Banded Bag with Rubberband and Tape, 91 cm x 51 cm (36 in x 20 in), Model 63620RT, pkgd. 25/case, sterile; (2) Ecolab... on 2023-06-23. FDA classified it as Class II and gives the reason as "Certain lots of the products have a Naphthalene odor". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2250-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-06-23
Posted: 2023-07-28
Recalling firm: Microtek Medical LLC
Product: Equipment and table drapes: (1) Ecolab Banded Bag with Rubberband and Tape, 91 cm x 51 cm (36 in x 20 in), Model 63620RT, pkgd. 25/case, sterile; (2) Ecolab Microtek Banded Bag with Elastic Opening, Circular, 102 cm (40 in), Model 60040S, pkgs. 25/case, sterile; (3) Ecolab Microtek Banded Bag with Elastic Opening, Circular, 127 cm (50 in), Model 60050S, pkgd. 25/case, sterile; (4) Ecolab Genesys Equipment Drape, Universal X-Ray Equipment Drape, 104 cm x 318 cm, Model 890017, pkgd. 6/case, sterile; and (5) Ecolab Genesys Microtek C-Arm / Mobile X-Ray Drape, 104 cm x 188 cm (41 in x 74 in), Model 4951N, pkgd. 50/case, sterile.
Product code: PUI Drape, Surgical, Exempt
Reason for recall: Certain lots of the products have a Naphthalene odor.
FDA root cause: Under Investigation by firm
Action: The recalling firm issued letters dated 6/15/2023 via email on 6/23/2023, unless they did not have an email address for the consignee, then those consignees were mailed a letter. The letter explained the reason for recall and requested the consignee immediately examine their inventory and quarantine the lots listed in the letter. The consignee is requested to dispose of product and packaging in accordance with hospital, administrative and/or local government policy and if unable to do so, they are instructed to call or email customer service to arrange for shipment of the affected product back to Ecolab. A response form was enclosed for return via email to report whether the consignee has affected product in their possession or not. The consignee is to indicate on the response form that they have read and understand the recall instructions, checked their stock and do not have any product to return, have checked their stock and are disposing of the listed inventory, or they have checked their stock and will send the listed inventory back to Ecolab. If the product was further distributed, the consignee is to identify and notify their customer at once of the product recall. A Distributor Response Form was also enclosed for completion. The Distributor Response Form is to report they have notified all customers that received the affected product and have provided their customers with a copy of the recall letter. The distributor is to report their customers' names, addresses, quantity of product shipped to the customer by SKU number and lot number, the amount the customer has available for disposal, and the date of disposal. The recall is being conducted to the user level.
Quantity in commerce: 9,293 cases/68,070 units for all products
Distribution: Worldwide distribution - US Nationwide and the country of Canada.
Product codes and lots: (1) Model 63620RT - Lot number 220301F, exp 3/3/2027; UDI-DI 00748426129386; (2) Model 60040S - Lot number 220305F, exp 3/5/2027; UDI-DI 00748426129348; (3) Model 60050S - Lot number 220305F, exp 3/5/2027; UDI-DI 00748426129355; (4) Model 890017 - Lot numbers 220110F, exp. 1/10/2027; 220108F, exp 1/8/2027; 220102F, exp 1/2/2027; and 211231F, exp 12/31/2026; UDI-DI 00748426063673; and (5) Model 4951N - Lot numbers 220110F, exp 1/10/2027; and 220109F, exp 1/9/2027; UDI-DI 00748426126767.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2250-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2250-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-07-28
Z-2251-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-07-28

Product code PUI

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)