CLASS II Device recall · Reported 29 Sep 2021 · FDA Enforcement Report
Bone Marrow Transplantation biopsy needle recalled by M.D.L. S.r.l
M.D.L is recalling Bone Marrow Transplantation biopsy needle, distributed nationwide in the US. The recall was initiated on 5 Aug 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-2489-2021
- FDA event ID
- 88430
- Recalling firm
- M.D.L, Delebio
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Aug 2021
- FDA classified
- 20 Sep 2021
- Reported
- 29 Sep 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Syringes & Needles
Timeline
| 5 Aug 2021 | Recall initiated by company | |
| 20 Sep 2021 | Classified by FDA | +46 days |
| 29 Sep 2021 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Sterility assurance may be compromised.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Bone Marrow Transplantation biopsy needle
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Sterility assurance may be compromised.
Which lots are affected?
Model PI1535/100, Lot Numbers: 3620D Model PIL1410/75, Lot Numbers: 1617A Model PIL1435/100, Lot Numbers: 1617A Model PIL1510/75, Lot Numbers: 3620D, 3620E Model PIL1535/100, Lot Numbers: 5216C, 3620D Model PIL1610/75, Lot Numbers: 3620D, 3620E, 4120 Model PIL1635/100, Lot Numbers: 5216C Model PIL1835/100, Lot Numbers: 5216C Model PIP1410/50, Lot Numbers: 1617A Model PIP1430/70, Lot Numbers: 1617A Model PIP1510/50, Lot Numbers: 1217B, 1618A Model PIP1530/70, Lot Numbers: 1617A Model PIP1630/70, Lot Numbers: 1617A Model PIP1810/50, Lot Numbers: 0818, 1618A Model PIP1830/70, Lot Numbers: 1617A Model PJ0810, Lot Numbers: 3620D Model PJ1110, Lot Numbers: 3620D, 4920B Model PJ1306, Lot Numbers: 3620D Model PJE1110, Lot Numbers: 5216, 5216C, 1417A, 3517C, 4617, 0818, 1418, 2518A, 4018, 4318D, 5018, 1119B, 1119C, 1119A, 3620D Model PJK21110, Lot Numbers: 3616C, 3620D Model PJK21115, Lot Numbers: 3416C Model PJK21310, Lot Numbers: 3416C, 3620D Model PJT0810, Lot Numbers: 4220B, 4320D, 4320D Model PJT0815, Lot Numbers: 4220D, 4320E Model PJT1110, Lot Numbers: 1417A, 3620D, 3620D, 3620D, 4220B, 4220B, 4220B, 4220A, 4320F, 4320D Model PJT1115, Lot Numbers: 3620D, 4220B, 4320D Model PJT1306, Lot Numbers: 1417A, 3517C, 3620D, 3620E, 4220B, 4320D Model PJT1310, Lot Numbers: 3620D, 4220B, 4420A, 4320D Model PS0810, Lot Numbers: 2518A, 1119A Model PS1110, Lot Numbers: 4316, 4316A, 4316B, 4316B, 2618, 4018, 3620D Model PS1115, Lot Numbers: 3620D Model PS1306, Lot Numbers: 3620D Model PS1310, Lot Numbers: 3916, 3620D
Where was it sold?
Nationwide
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
4 other products · FDA event 88430This product is part of a recall event; the main page for the event is Soft Tissue Biopsy Needles recalled by M.D.L. S.r.l.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Soft Tissue Biopsy Needles recalled by M.D.L. S.r.l | M.D.L | Sterility | Nationwide | |
| CLASS II | Mammary Nodules Localization recalled by M.D.L. S.r.l | M.D.L | Sterility | Nationwide | |
| CLASS II | General Manual surgical instrument recalled by M.D.L. S.r.l | M.D.L | Sterility | Nationwide | |
| CLASS II | Aspirated Cyto-Histological Biopsy needle recalled by M.D.L. S.r.l | M.D.L | Sterility | Nationwide |
More recalls from M.D.L
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Aspirated Cyto-Histological Biopsy needle recalled by M.D.L. S.r.l | M.D.L | Sterility | Nationwide |
| Device | CLASS II | General Manual surgical instrument recalled by M.D.L. S.r.l | M.D.L | Sterility | Nationwide |
| Device | CLASS II | Mammary Nodules Localization recalled by M.D.L. S.r.l | M.D.L | Sterility | Nationwide |
| Device | CLASS II | Soft Tissue Biopsy Needles recalled by M.D.L. S.r.l | M.D.L | Sterility | Nationwide |
Other Syringes & Needles recalls
All 1,060| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | BD Needle Kit for Powered Driver recalled by Bard Access Systems | Bard Access Systems | Other | 32 states |
| Device | CLASS II | Boston Scientific Enhance Transcarotid/Peripheral Access Kit recalled | Galt Medical | Other | Nationwide |
| Device | CLASS II | Geneva Brachytherapy Applicator recalled by Elekta | Elekta | Other | Nationwide |
| Device | CLASS II | Brachytherapy Applicator Advanced Gynecological Applicator recalled | Elekta | Other | Nationwide |
| Device | CLASS II | Medline 111 Gravity Set W/3 Needle Free Y-Sites recalled | BD Switzerland Sarl | Other | IL |