Moderate FDA (Devices)·Z-2251-2023·Announced 2023-08-09

Surgical table drapes and infection control kits recalled for naphthalene odor

Microtek Medical Inc. is recalling certain lots of surgical table drapes and infection control kits due to detection of naphthalene odor. The affected products are distributed nationwide in the US and in Canada.

What this means for you

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 hospitalizations, illnesses, injuries, or incidents. The hazard is described solely as a naphthalene odor without articulation of the specific risk to patients or product function, making this a quality or manufacturing issue rather than an acute safety threat.

Plain-English summary

Microtek Medical Inc. is recalling certain lots of surgical equipment used in operating room settings, including absorbent table covers with transfer sheets and armboard covers, and multiple models of infection control system kits from the Ecolab and CleanOp product lines. A total of 9,293 cases representing 68,070 units have been affected across 18 different product models.

The recalled products have been detected with a naphthalene odor in certain manufacturing lots. Affected lots are identified by specific lot numbers, with most products carrying expiration dates between July 2027 and January 2028.

These products were distributed nationwide in the United States and in Canada. Healthcare facilities and surgical centers may have received affected units.

The recalled product

Product: Equipment and table drapes and Surgical Room Turnover (SRT) Kits: (1) Ecolab Absorbent Table Cover W/Transfer Sheet & Armboard Covers, Model #ABTSLSAN, 20/case, non-sterile; (2) Microtek/Ecolab/CleanOp Absorbent Table Cover w/Transfer Sheet, Model ABTSLSN, 25/case, non-steril
Manufacturer: Microtek Medical Inc.
Category: Medical Device — Surgical Equipment / Operating Room Supplies
Hazard: naphthalene-odor

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 ABTSLSAN - Lot numbers 220309D
exp 3/9/2027
and 220302D
exp 3/2/2027
UDI-DI 50748426077262
(2) Model ABTSLSN - Lot number 220301D
exp 3/1/2027
UDI-DI 50748426077255
(3) Model ALHS-02 - Lot numbers 1392JX0100
exp 9/1/2027
2452JX3000
exp 11/1/2027
3402JX2000
exp 10/1/2027
4382JX0900
4442JX1100
and 5422JX0100
10/1/2027
UDI-DI 00748426133512
(4) Model ALHS-SS-01 - Lot number 6382JX1000

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 →

Same manufacturer · Microtek Medical Inc.

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Same hazard · naphthalene odor