Food, drugs, devices › Microtek Medical, Inc.
Device recall: Microtek Patient Drape ECOLAB AP6MMN Patient Drape, 6mm Adapter Plug Kit REF AP6MMN UDI code: (01)10748426139986 AP8MMN
Microtek Medical, Inc. (Alpharetta, GA) initiated this device recall on 13 Apr 2025; FDA lists 1 product record under event 96747, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 85% of the 945 device enforcement events initiated in 2025 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Microtek Medical, Inc. has 5 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Microtek Medical, Inc., Alpharetta, GA.
Reason for recall
"Due to non-sterile products being labeled as sterile"
Distribution
"U.S.: AL. AR, CA, CO, CT, FL, GA, IA, IL, IN, KY, MA, MI, NC, NY, OH, OR, TN, TX, and VA O.U.S.: N/A"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1963-2025 | 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… | 2,024 boxes | Class II | Ongoing | 18 Jun 2025 |
Context
Other enforcement events for Microtek Medical, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 3 Jun 2024 | C-Flow Bag Decanter, REF 2000S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 prod | Device | Class II | 5 |
| 23 Jun 2023 | Equipment and table drapes: (1) Ecolab Banded Bag with Rubberband and Tape, 91 cm x 51 cm (36 in x 20 in), Model 63620RT | Device | Class II | 2 |
| 8 Apr 2022 | TMJ Arthroscopy Drape, 85''x 96'' | Device | Class II | 1 |
| 10 Mar 2015 | FREEDOMAIRE(R) HELMET SYSTEM WITH SUPER POWER PAK BATTERY, LUMBAR BELT AND MOTOR MODULE, REF 11110STK, QTY 1/CS, NON STE | Device | Class II | 13 |
All 5 events for Microtek Medical, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Due to non-sterile products being labeled as sterile"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "U.S.: AL. AR, CA, CO, CT, FL, GA, IA, IL, IN, KY, MA, MI, NC, NY, OH, OR, TN, TX, and VA O.U.S.: N/A"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.