FDA Device recall Z-1963-2025
Microtek Patient Drape ECOLAB AP6MMN Patient Drape, 6mm Adapter Plug Kit REF AP6MMN UDI code: (01)10748426139986 AP8MMN Patient Drape, 8mm…
- FDA Device
- Class II
- ongoing
- Published 2025-06-18
On 2025-06-18 the FDA classified a Class II recall of Microtek Patient Drape ECOLAB AP6MMN Patient Drape, 6mm Adapter Plug Kit REF AP6MMN UDI code: (01)10748426139986 AP8MMN Patient Drape, 8mm… by Microtek Medical, citing due to non-sterile products being labeled as sterile.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1963-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-04-13 |
| Published | 2025-06-18 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Microtek Medical |
| Distribution | AL, AR, CA, CO, CT, FL, GA, IA, IL, IN, KY, MA, MI, NC, NY, OH, OR, TN, TX, VA |
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
Due to non-sterile products being labeled as sterile
Identifiers
| code_info | Catalog Number: AP6MMN UDI code: (01)10748426139986 Lot/Batch Numbers: 5272JX0300 7372JX3000 4422JX1900 1502JX0200 5502…Catalog Number: AP6MMN UDI code: (01)10748426139986 Lot/Batch Numbers: 5272JX0300 7372JX3000 4422JX1900 1502JX0200 5502JX0900 1023JX0200 6023JX0400 1334JX1400 Catalog Number: AP8MMN UDI code: (01)10748426139429 Lot/Batch Numbers: 3454LR3700 2484LR8000 1494LR0600 4025LR2800 2035LR5000 5342JX0600 3292JX0500 4372JX1700 5422JX0600 1402JX1500 4422JX1800 5502JX1000 1023JX3400 5133JX0100 3143JX1100 1173JX1800 6143JX0300 5213JX4000 4233JX1400 5243JX3700 6253JX1400 4293JX2400 1343JX1000 4353JX7800 2373JX0600 5443JX2500 3453JX2900 4463JX1200 3493JX1400 6503JX0300 2034JX1100 1044JX3400 5074JX1500 1104JX1100 5164JX0500 5164JX0700 5164JX0600 5184JX0800 5224JX1400 5234JX3400 1254JX0300 4304JX1100 2334JX1800 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1963-2025%22
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