Microtek Patient Drape Adapter Plug Kits Recalled for Non-Sterile Labeling
Microtek Medical is recalling Patient Drape adapter plug kits (models AP6MMN and AP8MMN) because non-sterile products were labeled as sterile. The affected adapters are used to connect drain hoses to fluid management devices.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall involving medical device sterility labeling misrepresentation. Non-sterile products labeled as sterile pose a risk of infection in clinical applications, meeting the threshold for Severe severity.
Plain-English summary
Microtek Medical, Inc. is recalling Microtek Patient Drape ECOLAB adapter plug kits—specifically the AP6MMN (6mm) and AP8MMN (8mm) models—because products that are not sterile have been labeled as sterile. These adapters are accessories designed to connect a drape's drain hose to a fluid management device and reduce the opening of the drain hose to a smaller size.
The affected products include 2,024 boxes distributed across the United States in the following states: Alabama, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Massachusetts, Michigan, North Carolina, New York, Ohio, Oregon, Tennessee, Texas, and Virginia.
Specific lot/batch numbers affected for the AP6MMN include 5272JX0300, 7372JX3000, 4422JX1900, 1502JX0200, 5502JX0900, 1023JX0200, 6023JX0400, and 1334JX1400. For the AP8MMN, affected lot/batch numbers are 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, and 2334JX1800.
Customers who have these products should stop using them and contact Microtek Medical, Inc. for instructions on return or replacement. For more information, visit the FDA's recall page at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=Z-1963-2025.
The recalled product
- 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…
- Manufacturer
- Microtek Medical, Inc.
- Affected units
- 2,024
Distribution
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