CLASS II Device recall · Reported 14 Apr 2021 · FDA Enforcement Report
BD BBL Martin-Lewis Agar, 100 Ea recalled by Becton Dickinson &
Becton Dickinson is recalling BD BBL Martin-Lewis Agar, 100 Ea, distributed nationwide in the US. The recall was initiated on 17 Mar 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1377-2021
- FDA event ID
- 87546
- Recalling firm
- Becton Dickinson, Sparks, MD
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Mar 2021
- FDA classified
- 8 Apr 2021
- Reported
- 14 Apr 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 17 Mar 2021 | Recall initiated by company | |
| 8 Apr 2021 | Classified by FDA | +22 days |
| 14 Apr 2021 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Products show heavy growth of C. albicans after 24 hours of incubation due to misformulation (expected reaction is partial inhibition after 18-48 hours incubation) and reduce the identification of Neisseria contributing to a delay in time to definitive diagnosis or a delay in proper treatment
Product as listed by the FDA
BD BBL Martin-Lewis Agar, 100 Ea - Product Usage: used for the isolation of pathogenic Neisseria from specimens containing mixed flora of bacteria and fungi. Catalog Number: 221558
Where it was distributed
Worldwide distribution - US Nationwide distribution and the countries of Canada, Korea.
Questions about this recall
Why was it recalled?
Products show heavy growth of C. albicans after 24 hours of incubation due to misformulation (expected reaction is partial inhibition after 18-48 hours incubation) and reduce the identification of Neisseria contributing to a delay in time to definitive diagnosis or a delay in proper treatment
Which lots are affected?
Lot Numbers: 0317559 Exp. Date 2021-MAR-11; 0345695 Exp. Date 2021-APR-06 UDI: 01)30382902215586 (10)0317559(17)031121 (30)0100 (01)30382902215586 (10)0345695(17)040621 (30)0100
Where was it sold?
Worldwide distribution - US Nationwide distribution and the countries of Canada, Korea.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 87546| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | BD BBL Martin-Lewis Agar 20 Ea recalled by Becton Dickinson & | Becton Dickinson | Other | Nationwide |
More recalls from Becton Dickinson
All 364| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | BD¿Spinal Tray with BD¿Whitacre Needle recalled by Becton Dickinson & | Becton Dickinson | Processing Deviation | Nationwide |
| Device | CLASS I | BD¿Spinal Tray with BD¿Whitacre Needle recalled by Becton Dickinson & | Becton Dickinson | Processing Deviation | Nationwide |
| Device | CLASS I | BD¿Spinal Tray with BD¿Quincke Needle recalled by Becton Dickinson & | Becton Dickinson | Processing Deviation | Nationwide |
| Device | CLASS I | BD¿Spinal Tray with BD¿Whitacre Needle recalled by Becton Dickinson & | Becton Dickinson | Processing Deviation | Nationwide |
| Device | CLASS I | BD¿Spinal Tray with BD¿Whitacre Needle, BD¿Quincke Needle recalled | Becton Dickinson | Processing Deviation | Nationwide |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |