Z-2562-2021Class II

LYMOL Medical Elite X Class Rigid Bronchoscope System, Part No. BD2410, BB2701, BB2702, BB2401, BB2402...

Name: Z-2562-2021 LYMOL Medical Elite X Class Rigid Bronchoscope System, Part No. BD2410, BB2701, BB2702, BB2401, BB2402...
Creator: Lymol Medical Corporation
Published: 2021-07-29
License: https://open.fda.gov/license/

Lymol Medical Corporation / initiated 2021-07-29 / Terminated

FDA source

Lymol Medical Corporation began a recall of LYMOL Medical Elite X Class Rigid Bronchoscope System, Part No. BD2410, BB2701, BB2702, BB2401, BB2402, BA2700, BT2000, BT2101, BT2103, BT2105, BT2106, BT2210... on 2021-07-29. FDA classified it as Class II and gives the reason as "Reprocessing instructions were revised November 15, 2020, to reflect new processes and equipment used at consignee user facilities. New instructions were not sent to all consignees of the devices at the time of the...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2562-2021
Classification: Class II
Status: Terminated
Initiated: 2021-07-29
Posted: 2021-09-24
Terminated: 2022-10-04
Recalling firm: Lymol Medical Corporation
Product: LYMOL Medical Elite X Class Rigid Bronchoscope System, Part No. BD2410, BB2701, BB2702, BB2401, BB2402, BA2700, BT2000, BT2101, BT2103, BT2105, BT2106, BT2210, BT2201, BT2203, BT2205, BR2200, BP2200, BI2200, BR2000, BP2000, BI2999, BR2103, BP2103, BI2103, BR2101, BP2101, BI2101, BI2001, BDL2420
Product code: EOQ Bronchoscope (Flexible Or Rigid)
Reason for recall: Reprocessing instructions were revised November 15, 2020, to reflect new processes and equipment used at consignee user facilities. New instructions were not sent to all consignees of the devices at the time of the revision.
FDA root cause: Under Investigation by firm
Action: On August 9, 2021, the firm began notifying all consignees via email that the reprocessing instructions have changed. Included with each notification is a copy of the Urgent Notice, the revised IFU, and a response form. Customers were advised that the sterilization procedures were updated on November 15, 2020. Customers should discard and replace the obsolete procedures with the revised procedures included with the firm's mailing. The revised instructions have been uploaded to the LYMOL website at https://www.lymolmedical.com/instructions.cfm Customers with questions may contact the firm at [email protected].
Quantity in commerce: 309
Distribution: US Nationwide distribution.
Product codes and lots: All distributed lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2562-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2562-2021	Class II	Terminated	Voluntary: Firm initiated	2021-10-06	2021-09-24

Product code EOQ

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)