Z-1488-2012

BOMImed Reusable Integrated Fiber Optic Laryngoscope Blades, MacIntosh and Miller styles - all sizes...

Name: Z-1488-2012 BOMImed Reusable Integrated Fiber Optic Laryngoscope Blades, MacIntosh and Miller styles - all sizes...
Creator: Bomimed Inc
Published: 2010-12-08
License: https://open.fda.gov/license/

Bomimed Inc / initiated 2010-12-08 / Terminated / root cause: manufacturing process

FDA source

Bomimed Inc began a recall of BOMImed Reusable Integrated Fiber Optic Laryngoscope Blades, MacIntosh and Miller styles - all sizes. Instrument is used to aid with intubation on 2010-12-08. The reason FDA records is "On 9/1/2010 BOMImed, Inc. Winnipeg, MB, Canada initiated a recall of their BOMImed Integrated Reusable Laryngoscope Blades (Macintosh & Miller styles - all sizes), Model #OL-32D0 to OL-32D4 & OL-32E00, OL-32E0, OL-32E1...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1488-2012
Status: Terminated
Initiated: 2010-12-08
Posted: 2012-05-03
Terminated: 2012-05-08
Recalling firm: Bomimed Inc
Product: BOMImed Reusable Integrated Fiber Optic Laryngoscope Blades, MacIntosh and Miller styles - all sizes. Instrument is used to aid with intubation.
Product code: EQN Laryngoscope, Nasopharyngoscope
Reason for recall: On 9/1/2010 BOMImed, Inc. Winnipeg, MB, Canada initiated a recall of their BOMImed Integrated Reusable Laryngoscope Blades (Macintosh & Miller styles - all sizes), Model #OL-32D0 to OL-32D4 & OL-32E00, OL-32E0, OL-32E1, OL-32E2, OL-32E3, OL-32E4.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: BOMImed sent a "Medical Device Safety Alert & Correction Action" letter by Fax and Mail on 11/25/2010 to the consignee. The product issue was described and recommended actions to mitigate risk were provided. Contact number is 1-800-667-6276 ext. 234.
Quantity in commerce: 30 units
Distribution: US Distribution to the state of California.
Product codes and lots: Lot Numbers 0310, 0510, 2710, 3210, 4010 & 4510

Product code EQN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)