The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2250-2023·Announced 2023-08-09

Ecolab Medical Device Drapes Recalled for Naphthalene Odor

Microtek Medical Inc. is recalling certain lots of Ecolab sterile medical device drapes due to naphthalene odor. The recall affects five models distributed in the United States and Canada.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is a Class II recall with no reported illnesses, injuries, or hospitalizations. The naphthalene odor represents a potential contamination concern, but without documented harm or safety incidents, it qualifies as a precautionary quality recall. Per the rubric, the absence of reported incidents limits the score to at most 3, and the lack of explicit risk articulation places this in the Moderate category.

Plain-English summary

Microtek Medical Inc. is recalling certain lots of Ecolab sterile medical device drapes that were distributed nationwide in the United States and Canada. The recall affects five models of equipment and table drapes used in surgical and diagnostic imaging applications: Ecolab Banded Bag with Rubberband and Tape (Model 63620RT), Ecolab Microtek Banded Bags with Elastic Opening in two sizes (Models 60040S and 60050S), Ecolab Genesys Universal X-Ray Equipment Drape (Model 890017), and Ecolab Genesys Microtek C-Arm/Mobile X-Ray Drape (Model 4951N).

The recall was initiated because certain lots of these products have a naphthalene odor. Approximately 9,293 cases, comprising 68,070 individual units across all affected models, have been distributed.

Specific lot numbers and expiration dates are available for each model to identify affected products in healthcare facilities and institutional inventories.

The recalled product

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…
Manufacturer
Microtek Medical Inc.
Category
Medical Device — Surgical and Diagnostic Drapes
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • (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
  • 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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Microtek Medical Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Microtek Medical Inc.

See all →

Same hazard · naphthalene odor

See all →

Similar recalls