Drug & Device Safety Atlas
Class II FDA device recall · Z-1963-2025

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.

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.

Why it was recalled

Due to non-sterile products being labeled as sterile

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
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

Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

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

Recall record

Recalling firm
Microtek Medical, Inc.
Product type
Devices
Recall number
Z-1963-2025
Voluntary / mandated
Voluntary: Firm initiated
Initial notification
Letter
Origin
Alpharetta, GA
Recall initiated
2025-04-13

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-1963-2025 · Source: openFDA enforcement.