The Recall Desk
HighFDA (Devices)·Z-2562-2021·Announced 2021-10-06

LYMOL Medical Elite X Class Rigid Bronchoscope System — Updated reprocessing instructions not distributed

Lymol Medical Corporation recalled the LYMOL Medical Elite X Class Rigid Bronchoscope System because updated reprocessing instructions issued November 15, 2020, were not sent to all consignees of the devices.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a risk-of-harm medical device recall where improper reprocessing instructions could lead to inadequate sterilization if facilities use outdated procedures. FDA Class II classification with no reported illnesses or injuries places this at the high-risk level under the rubric criteria for products with injury risk but no reported harm.

Plain-English summary

The LYMOL Medical Elite X Class Rigid Bronchoscope System, manufactured by Lymol Medical Corporation, has been recalled. The system includes multiple components with various part numbers, with 309 units distributed nationwide in the United States.

On November 15, 2020, Lymol Medical Corporation revised the reprocessing instructions to reflect new processes and equipment used at consignee user facilities. However, the revised instructions were not sent to all consignees of the devices at the time of the revision.

This recall is issued because some healthcare facilities and clinicians may continue using outdated reprocessing instructions that do not align with the updated processes and equipment now in use at their facilities.

Users of the LYMOL Medical Elite X Class Rigid Bronchoscope System should verify they have received the reprocessing instructions revised on November 15, 2020. If instructions have not been received, they should contact Lymol Medical Corporation to obtain them.

The recalled product

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,
Manufacturer
Lymol Medical Corporation
Category
Medical Device — Surgical Instruments / Bronchoscope
Hazard
  • improper-reprocessing

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All distributed lots

Distribution

Distributed nationwide across the United States.

Related recalls

Same category