Microtek Medical Inc.: 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.

Recall number

Z-2250-2023

Recalling firm

Microtek Medical Inc.

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.

Status

Open, Classified

Initiated

2023-06-23

Posted

2023-07-28

Terminated

not on file

Reason

Certain lots of the products have a Naphthalene odor.

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

9,293 cases/68,070 units for all products

Distribution

Worldwide distribution - US Nationwide and the country of Canada.

Lot, serial or model codes

(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.

510(k) numbers

not on file

PMA numbers

not on file

Product code

PUI

Firm FEI

3014342658

Firm city

Saint Paul

Firm state

MN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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