Z-1963-2025Class II

Microtek Patient Drape ECOLAB AP6MMN Patient Drape, 6mm Adapter Plug Kit REF AP6MMN UDI code...

Name: Z-1963-2025 Microtek Patient Drape ECOLAB AP6MMN Patient Drape, 6mm Adapter Plug Kit REF AP6MMN UDI code...
Creator: Microtek Medical, Inc.
Published: 2025-04-13
License: https://open.fda.gov/license/

Microtek Medical LLC / initiated 2025-04-13 / Open, Classified / root cause: labeling and UDI

FDA source

Microtek Medical, Inc. began a recall of 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... on 2025-04-13. FDA classified it as Class II and gives the reason as "Due to non-sterile products being labeled as sterile". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1963-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-04-13
Posted: 2025-06-12
Recalling firm: Microtek Medical LLC
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.
Product code: PUI Drape, Surgical, Exempt
Reason for recall: Due to non-sterile products being labeled as sterile
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: On 04/13/2025, the firm sent via FedEx a Customer Notification Letter to customers informing them there was a label error on products AP6MMN and AP8MMN where the products that were not designed or intended to be sterile and have not gone through any sterilization were labeled as sterile. Customer are instructed to: immediately examine your inventory for the lots listed in Attachment A and remove all products from your inventory regardless of its location and segregate this product in a secure location. The lot number can be found on the individual package or case label. If you have an affected product in your possession, please dispose of the product and packaging in according to your hospital, administrative and /or local government policy. If you are unable to dispose of the product, please send the product back to: Medline / Microtek Medical LLC. 13500 Tradeport Circle E Jacksonville, FL, 32218 USA For questions/assistance - contact Customer Service at 1-800-633-5463 (Medline). The firm is planning on communicating an updated letter in the near future.
Quantity in commerce: 2,024 boxes
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 codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1963-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1963-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-18	2025-06-12

Product code PUI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)