Equipment and table drapes and Surgical Room Turnover (SRT) Kits: (1) Ecolab Absorbent Table C...
FDA Device Recall #Z-2251-2023 — Class II — June 23, 2023
Recall Summary
| Recall Number | Z-2251-2023 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 23, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Microtek Medical Inc. |
| Location | Saint Paul, MN |
| Product Type | Devices |
| Quantity | 9,293 cases/68,070 units for all products |
Product Description
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 for Recall
Certain lots of the products have a Naphthalene odor.
Distribution Pattern
Worldwide distribution - US Nationwide and the country of Canada.
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.
Other Recalls from Microtek Medical Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2640-2024 | Class II | Bag Decanter II, REF 2002S. Packaged on a form,... | Jun 3, 2024 |
| Z-2642-2024 | Class II | Vial Decanter, REF 2006S. Packaged on a form, f... | Jun 3, 2024 |
| Z-2641-2024 | Class II | Bottle Decanter, REF 2004S. Packaged on a form,... | Jun 3, 2024 |
| Z-2639-2024 | Class II | C-Flow Bag Decanter, REF 2000S. Packaged on a f... | Jun 3, 2024 |
| Z-2643-2024 | Class II | Transfer Device, REF 2008S. Packaged on a form,... | Jun 3, 2024 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.