FDA Device recall Z-2251-2023

Equipment and table drapes and Surgical Room Turnover (SRT) Kits: (1) Ecolab Absorbent Table Cover W/Transfer Sheet & Armboard Covers, Mode…

FDA Device
Class II
ongoing
Published 2023-08-09

On 2023-08-09 the FDA classified a Class II recall of Equipment and table drapes and Surgical Room Turnover (SRT) Kits: (1) Ecolab Absorbent Table Cover W/Transfer Sheet & Armboard Covers, Mode… by Microtek Medical, citing certain lots of the products have a Naphthalene odor.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2251-2023
Classification	Class II
Status	ongoing
Initiated	2023-06-23
Published	2023-08-09
Last updated	2026-09-13 11:56 UTC
Company	Microtek Medical
Distribution	US

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-sterile; (5) Ecolab CleanOp Infection Control System, Model BPGN-02, 10/case, non-sterile; (6) Ecolab Genesys CleanOp Infection Control System, Model HFH-02, 12/case, non-sterile; (7) Ecolab Genesys CleanOp Infection Control System, Model HKHA-02, 15/case, non-sterile; (8) Ecolab CleanOp Infection Control System, Model JFKSC-01, 15/case, non-sterile; (9) Ecolab Genesys CleanOp Infection Control System, Model LH-LD-05, 12/case, non-sterile; (10) Ecolab CleanOp Infection Control System, Model NEGM-CV-01D, 9/case, non-sterile; (11) Ecolab Genesys CleanOp Infection Control System, Model PMMC-02D, 12/case, non-sterile; (12) Ecolab Genesys CleanOp Infection Control System, Model PMMC-SP-01D, 12/case, non-sterile; (13) Ecolab Genesys CleanOp Infection Control System, Model SHMC-06, 15/case, non-sterile; (14) Ecolab CleanOp Infection Control System, Model SR-01D, 12/case, non-sterile; (15) Ecolab CleanOp Infection Control System, Model SVB-OSC-01, 12/case, non-sterile; (16) Ecolab CleanOp Infection Control System, Model UCLA-LD-03, 12/case, non-sterile; (17) Ecolab CleanOp Infection Control System, Model VAIC-03, 12/case, non-sterile; and (18) Ecolab Genesys CleanOp Infection Control System, Model VAIC-CP-02, 15/case, non-sterile.

Reason

Certain lots of the products have a Naphthalene odor.

Identifiers

code_info	(1) Model ABTSLSAN - Lot numbers 220309D, exp 3/9/2027; and 220302D, exp 3/2/2027; UDI-DI 50748426077262; (2) Model ABT… (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 007484

code_info

(1) Model ABTSLSAN - Lot numbers 220309D, exp 3/9/2027; and 220302D, exp 3/2/2027; UDI-DI 50748426077262; (2) Model ABT…

(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 007484

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2251-2023%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.