Microtek Patient Drape ECOLAB AP6MMN Patient Drape — Class II medical device recall Z-1963-2025
Ongoing recall by Microtek Medical, Inc., reported 2025-06-18, distributed in AL, AR, CA, CO, CT, FL, GA, IA…. Due to non-sterile products being labeled as sterile
| Recall number | Z-1963-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Microtek Medical, Inc., Alpharetta, GA, United States |
| Recall initiated | 2025-04-13 |
| Classified | 2025-06-12 |
| Reported by FDA | 2025-06-18 |
| Distributed | AL, AR, CA, CO, CT, FL, GA, IA, IL, IN, KY, MA, MI, NC, NY, OH, OR, TN, TX, VA |
| Quantity | 2,024 boxes |
| Reason classes | labeling, sterility |
| UPC / GTIN / UDI-DI | 10748426139429, 10748426139986 |
| Lot numbers | 1023JX0200, 1023JX3400, 1044JX3400, 1104JX1100, 1173JX1800, 1254JX0300, 1334JX1400, 1343JX1000, 1402JX1500, 1494LR0600, 1502JX0200, 2034JX1100, 2035LR5000, 2334JX1800, 2373JX0600, 2484LR8000, 3143JX1100, 3292JX0500, 3453JX2900, 3454LR3700, 3493JX1400, 4025LR2800, 4233JX1400, 4293JX2400, 4304JX1100, 4353JX7800, 4372JX1700, 4422JX1800, 4422JX1900, 4463JX1200, 5074JX1500, 5133JX0100, 5164JX0500, 5164JX0600, 5164JX0700, 5184JX0800, 5213JX4000, 5224JX1400, 5234JX3400, 5243JX3700 and 11 more |
| Model numbers | AP6MMN, AP8MMN |
Product
Microtek Patient Drape ECOLAB AP6MMN Patient Drape, 6mm Adapter Plug Kit REF AP6MMN UDI code: (01)10748426139986 AP8MMN Patient Drape, 8mm Adapter Plug Kit REF AP8MMN UDI code: (01)10748426139429 These adapters function as accessories for a device or drape, serving to connect a drape's drain hose to a fluid management device. Their purpose is to reduce the opening of the drain hose to a smaller size.
Reason for recall
Due to non-sterile products being labeled as sterile
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1963-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.