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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Microtek Medical Inc.: Certain lots of the products have a Naphthalene odor.

Agency Publication Date: July 28, 2023
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Affected Products

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,

(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.

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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-sterile; Surgical Room Turnover (SRT) Kits: (3) Ecolab Genesys CleanOp Infection Control System, Model ALHS-02, 12/case, non-sterile; (4) Ecolab Genesys CleanOp Infection Control System, Model ALHS-SS-01, 12/case, non-s

(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, exp 9/1/2027; 4442JX1100, exp 11/1/2027; and 5422JX0100, 10/1/2027; UDI-DI 00748426133512; (4) Model ALHS-SS-01 - Lot number 6382JX1000, exp 9/1/2027; UDI-DI 00748426123131; (5) Model BPGN-02 - Lot numbers 2362JX2100, exp 9/1/2027; and 5412JX3200, exp 10/1/2027; UDI-DI 00748426080021; (6) Model HFH-02 - Lot number 2362JX1000, exp 9/1/2027; UDI-DI 00748426124688; (7) Model HKHA-02 - Lot numbers 1372JX0400, exp 9/1/2027; and 3412JX0700, exp 10/1/2027; UDI-DI 00748426077809; (8) Model JFKSC-01 - Lot numbers 6372JX1200, exp 9/1/2027; and 6372JX1300, exp 9/1/2027; UDI-DI 00748426078417; (9) Model LH-LD-05 - Lot numbers 7372JX2400, exp 9/1/2027; and 2422JX1900, exp 10/1/2027; UDI-DI 00748426082803; (10) Model NEGM-CV-01D - Lot numbers 5322JX1100, exp 8/12/2027; and 2013JX3400, exp 1/3/2028; UDI-DI 00748426132034; (11) Model PMMC-02D - Lot numbers 2332JX0900, exp 8/1/2027; 3362JX1200, exp 9/1/2027; and 2422JX2200, 10/1/2027; UDI-DI 00748426132034; (12) Model PMMC-SP-01D - Lot numbers 6282JX2600, exp 7/1/2027; 7372JX1900, exp 9/1/2027; 2412JX2300, exp 10/1/2027; and 6432JX0500, 10/1/2027; UDI-DI 00748426125753; (13) Model SHMC-06 - Lot numbers 2342JX0100, exp 8/1/2027; 1372JX0200, exp 9/1/2027; 3402JX1300, exp 10/1/2027; 6422JX0700, exp 10/1/2027; 6442JX0100, exp 11/1/2027; and 5312JX0100, exp 8/1/2027; UDI-DI 00748426068258; (14) Model SR-01D - Lot numbers 1362JX0300, exp 9/5/2027; and 5372JX0700, exp 9/16/2027; UDI-DI 00748426128723; (15) Model SVB-OSC-01 - Lot numbers 3392JX0100, exp 9/1/2027; and 2412JX3300, exp 10/1/2027; UDI-DI 00748426109326; (16) Model UCLA-LD-03 - Lot number 3382JX2100, exp 9/1/2027; UDI-DI 00748426115228; (17) Model VAIC-03 - Lot numbers 3282JX2500, exp 7/1/2027; 1442JX0600, 10/1/2027; 2432JX1700, exp 10/1/2027; and 4023JX3100, 1/1/2028; UDI-DI 00748426078837; and (18) Model VAIC-CP-02 - Lot number 5332JX2100, exp 8/1/2027; UDI-DI 00748426078813.

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Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92577
Status: Active
Manufacturer: Microtek Medical Inc.
Manufactured In: United States
Units Affected: 2 products (9,293 cases/68,070 units for all products)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.