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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96747

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
April 13, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Microtek Medical, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-1963-2025
Recall number
Z-1963-2025
Initiated
April 13, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Microtek Medical, Inc.
Quantity
2,024 boxes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
non-sterile products being labeled as sterile

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to non-sterile products being labeled as sterile

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

Distribution pattern

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