FDA Medical Device Recalls (openFDA)
Lymol Medical Corporation: 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
- Recall number
- Z-2562-2021
- 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
- Status
- Terminated
- Initiated
- 2021-07-29
- Posted
- not on file
- Terminated
- 2022-10-04
- Reason
- 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.
- 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 Kabrano@lymolmedical.com.
- Quantity
- 309
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- All distributed lots
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- EOQ
- Firm FEI
- 1221129
- Firm city
- Woburn
- Firm state
- MA
- Firm country
- not on file
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