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RecallWatchMedical Device Safety
Class IIOngoingZ-1963-2025

Microtek Medical, Inc. recalls Microtek Patient Drape ECOLAB AP6MMN Patient Drape

Microtek Medical, Inc.Alpharetta, GA, United StatesReported Jun 18, 2025 · 1 year ago
Legal News Analyst ·

Reason for recall

Due to non-sterile products being labeled as sterile

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • 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
    UDI codeCatalog # Number
    52 affected lots
    5272JX03007372JX30004422JX19001502JX02005502JX09001023JX02006023JX04001334JX1400
    +44 moreAP8MMN3454LR37002484LR80001494LR06004025LR28002035LR50005342JX06003292JX05004372JX17005422JX06001402JX15004422JX18005502JX10001023JX34005133JX01003143JX11001173JX18006143JX03005213JX40004233JX14005243JX37006253JX14004293JX24001343JX10004353JX78002373JX06005443JX25003453JX29004463JX12003493JX14006503JX03002034JX11001044JX34005074JX15001104JX11005164JX05005164JX07005164JX06005184JX08005224JX14005234JX34001254JX03004304JX11002334JX1800

What the firm is doing

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.

DistributionShow details

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

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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