FDA Medical Device Recalls (openFDA)
Microcuff Gmbh: Microcuff Endotracheal Tube; Pediatric Oral/Nasal Magill: ID Size: 3,0mm, Microcuff Product Reference: I-MPEDC-30; ID Size: 3,5mm, Product Reference: I-MPEDC-35; ID Size: 4,0mm, Product Reference: I-MPEDC-40; ID Size: 4.5mm, Product Reference: I-MPEDC-45; ID Size: 5,0mm, Product Reference: I-MPEDC-50; ID Size: 5,5mm, Product Reference: I-MPEDC-55; ID Size: 6,0mm, Product Reference: I-MPEDC-60; ID Size: 6,5mm, Product Reference: I-MPEDC-65 and ID Size: 7,0mm, Product Reference: I-MPEDC-70 * Sterile * Single use only * Manufactured by Euromedical Industries, Sdn. Bhd., Bakar Arang Industrial Estate, 08000 Sungai Patani, Kedah, Malaysia * Distributed by: Microcuff GmbH, Hohnerweg 2-4, D-69469 Weinheim, Germany.
- Recall number
- Z-1263-06
- Recalling firm
- Microcuff Gmbh
- Product
- Microcuff Endotracheal Tube; Pediatric Oral/Nasal Magill: ID Size: 3,0mm, Microcuff Product Reference: I-MPEDC-30; ID Size: 3,5mm, Product Reference: I-MPEDC-35; ID Size: 4,0mm, Product Reference: I-MPEDC-40; ID Size: 4.5mm, Product Reference: I-MPEDC-45; ID Size: 5,0mm, Product Reference: I-MPEDC-50; ID Size: 5,5mm, Product Reference: I-MPEDC-55; ID Size: 6,0mm, Product Reference: I-MPEDC-60; ID Size: 6,5mm, Product Reference: I-MPEDC-65 and ID Size: 7,0mm, Product Reference: I-MPEDC-70 * Sterile * Single use only * Manufactured by Euromedical Industries, Sdn. Bhd., Bakar Arang Industrial Estate, 08000 Sungai Patani, Kedah, Malaysia * Distributed by: Microcuff GmbH, Hohnerweg 2-4, D-69469 Weinheim, Germany.
- Status
- Terminated
- Initiated
- 2006-06-19
- Posted
- 2006-07-25
- Terminated
- 2007-05-01
- Reason
- Inadequate seals and/or holes in the pouch may compromise the sterility of the product.
- Root cause
- Other
- Action
- A notification by telephone was made in April 2006. A confirmation letter was later sent on 6/29/2006.
- Quantity
- 1730 units (total for all three types)
- Distribution
- U.S.
- Lot, serial or model codes
- All lots of the product manufactured are being recalled.
- 510(k) numbers
- ["K050803"]
- PMA numbers
- not on file
- Product code
- BTR
- Firm FEI
- 3005301443
- Firm city
- Weinheim
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28