CLASS II ONGOING Device recall · Reported 9 Aug 2023 · FDA Enforcement Report

Equipment and table drapes: Ecolab Banded Bag recalled

Microtek Medical is recalling Equipment and table drapes: Ecolab Banded Bag with Rubberband and Tape, distributed nationwide in the US. The recall was initiated on 23 Jun 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date 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.

Quantity recalled9,293 cases/68,070 units for all products

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2250-2023
FDA event ID: 92577
Recalling firm: Microtek Medical, Saint Paul, MN
Classification: Class II
Status: Ongoing
Recall initiated: 23 Jun 2023
FDA classified: 28 Jul 2023
Reported: 9 Aug 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Device type: Imaging Equipment

Timeline

23 Jun 2023	Recall initiated by company
28 Jul 2023	Classified by FDA	+35 days
9 Aug 2023	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Certain lots of the products have a Naphthalene odor.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

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.

Where it was distributed

Worldwide distribution - US Nationwide and the country of Canada.

Nationwide

Questions about this recall

Is Equipment and table drapes: Ecolab Banded Bag with Rubberband and Tape recalled?

Yes. Microtek Medical recalled Equipment and table drapes: Ecolab Banded Bag with Rubberband and Tape on 23 Jun 2023. The recall is Class II and its status is Ongoing. Recall number Z-2250-2023.

Why was it recalled?

Certain lots of the products have a Naphthalene odor.

Which lots are affected?

(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.

Where was it sold?

Worldwide distribution - US Nationwide and the country of Canada.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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