Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.
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.
Why it was recalled
Certain lots of the products have a Naphthalene odor.
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / code information
(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.
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
Worldwide distribution - US Nationwide and the country of Canada.
Recall record
- Recalling firm
- Microtek Medical Inc.
- Product type
- Devices
- Recall number
- Z-2251-2023
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Letter
- Origin
- Saint Paul, MN
- Recall initiated
- 2023-06-23
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall Z-2251-2023 · Source: openFDA enforcement.