Z-0803-2020Class II

BriteBlade Pro Single-Use Fiber Optic Handle and Blade Mac 3, CE 0120, Do not Re-use, Rx Only, REF, 040-333U...

Name: Z-0803-2020 BriteBlade Pro Single-Use Fiber Optic Handle and Blade Mac 3, CE 0120, Do not Re-use, Rx Only, REF, 040-333U...
Creator: Flexicare Medical Ltd.
Published: 2019-11-27
License: https://open.fda.gov/license/

Flexicare Medical Ltd. / initiated 2019-11-27 / Terminated / root cause: manufacturing process

FDA source

Flexicare Medical Ltd. began a recall of BriteBlade Pro Single-Use Fiber Optic Handle and Blade Mac 3, CE 0120, Do not Re-use, Rx Only, REF, 040-333U, Sterile EO, Qty 10... on 2019-11-27. FDA classified it as Class II and gives the reason as "The firm has received reports that the spring/washer/bearing components in the block of the laryngoscope blade become loose and separated from the device. If the blade is disengage over the patient's mount it is a...". 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-0803-2020
Classification: Class II
Status: Terminated
Initiated: 2019-11-27
Posted: 2020-01-13
Terminated: 2021-04-27
Recalling firm: Flexicare Medical Ltd.
Product: BriteBlade Pro Single-Use Fiber Optic Handle and Blade Mac 3, CE 0120, Do not Re-use, Rx Only, REF, 040-333U, Sterile EO, Qty 10, (01)15055788724138(17)230801(10)180900072 The device is intended for direct vision laryngoscopy to obtain an illuminated view of the vocal cords and the glottis by insertion into the oral cavity to manipulate the tongue and/or the epiglottis.
Product code: OGH Laryngoscope Kit
Reason for recall: The firm has received reports that the spring/washer/bearing components in the block of the laryngoscope blade become loose and separated from the device. If the blade is disengage over the patient's mount it is a possibility that any loose parts could enter the oral cavity which could cause a delay in the procedure while retrieving loose parts.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 11/27/2019, the firm "Flexicare" sent a "Urgent: medical Device Recall" letter via USPS Priority mail. The letter informed consignees of the recall. In addition to informing consignees of the recall the letter asked consignees to take the following actions: Complete the acknowledgment and receipt form and return this form to Flexicare Inc. On receipt of the form you will be contacted by a representative of Flexicare Inc. to make all necessary further arrangements. The form asked the following of the consignee: -Acknowledge that you have read and understand the recall instructions provided - If you have experienced any adverse events associated with the recalled products. - Check your stock and quarantined inventory - Send completed response forms marked for the attention of Product Manager Anesthesia to email [email protected] or by fax to 949-450-9992 - Identify and notify your customers that were shipped product from the affected lot numbers If you have any questions, please call Product Manager Anesthesia, at 949-450-9999 ext. 102 or email at [email protected].
Quantity in commerce: 1,024,890 devices
Distribution: US: Nationwide OUS: Australia, Canada, China, Czech Republic, Denmark, Finland, Ireland, Italy, Kuwait, Lebanon, Netherlands, Panama, Romania, Russia, South Korea, UAE, UK
Product codes and lots: Part Number/Lot Number 040-333U 170900328 I OGH 040-333U 180800461 I OGH 040-333U 180900072 I OGH 040-333U 180900104 I OGH 040-333U 181000107 I OGH 040-333U 181100013 I OGH 040-333U 181100097 I OGH 040-333U 181200024 I OGH

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0803-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0801-2020	Class II	Terminated	Voluntary: Firm initiated	2020-01-22	2020-01-13
Z-0802-2020	Class II	Terminated	Voluntary: Firm initiated	2020-01-22	2020-01-13
Z-0803-2020	Class II	Terminated	Voluntary: Firm initiated	2020-01-22	2020-01-13
Z-0804-2020	Class II	Terminated	Voluntary: Firm initiated	2020-01-22	2020-01-13

Product code OGH

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)