FDA Medical Device Recalls (openFDA)
Penlon, Ltd.: Crystal Metal Disposable Blades size Mac 4 (part number 50674, 50674/F, 50674/BMI) and Mac 3 (part numbers 50675, 50675/F, 50675/BMI) Product Usage: Disposable laryngoscope blades.
- Recall number
- Z-1221-2012
- Recalling firm
- Penlon, Ltd.
- Product
- Crystal Metal Disposable Blades size Mac 4 (part number 50674, 50674/F, 50674/BMI) and Mac 3 (part numbers 50675, 50675/F, 50675/BMI) Product Usage: Disposable laryngoscope blades.
- Status
- Terminated
- Initiated
- 2011-09-21
- Posted
- 2012-03-18
- Terminated
- 2012-06-19
- Reason
- Disposable laryngoscope blades incorrectly labeled with wrong size.
- Root cause
- Error in labeling
- Action
- InterMed Penlon sent and Urgent Field Safety Notice letter dated September 21, 2011 to affected customers. The letter identified the affected product, problem and advice on actions to be taken by user. Customers were instructed to complete the Reply Form and send to the address provided.
- Quantity
- 24,940 cartons
- Distribution
- Worldwide Distribution - USA (nationwide) in the countries of Belgium, France, Greece, Ireland, Italy, Lithuania, Netherlands, Norway, Portugal, Switzerland, Canada, China, Hong Kong and Malaysia.
- Lot, serial or model codes
- All lots with expiration dates between August 2011 and August 2016.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CCW
- Firm FEI
- 3002807907
- Firm city
- Abingdon
- Firm state
- not on file
- Firm country
- United Kingdom
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