Bone Marrow Biopsy Needles Recalled for Sterility Assurance Concerns
M.D.L. S.r.l. is recalling approximately 21,518 bone marrow biopsy needles distributed nationwide because sterility assurance may be compromised.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II device with no reported illnesses, injuries, or deaths. The hazard—potential sterility compromise—is theoretical. This meets the Score 3 criterion: a risk-of-harm medical device where injury has not yet been reported.
Plain-English summary
M.D.L. S.r.l. is recalling approximately 21,518 bone marrow transplantation biopsy needles that were distributed nationwide. The needles are available in multiple models and are identified by specific lot numbers provided in the recall notice.
The recall was issued because sterility assurance may be compromised on the affected units. Medical device sterility is essential for patient safety, particularly in procedures such as bone marrow transplantation.
Patients who have received these biopsy needles and their healthcare providers should be aware of this recall. Individuals with concerns about needles they may have received should contact their healthcare provider or M.D.L. S.r.l. directly for additional information and guidance.
The recalled product
- Product
- Bone Marrow Transplantation biopsy needle
- Manufacturer
- M.D.L. S.r.l.
- Hazard
- Affected units
- 21,518
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 (20)
- 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
- 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
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by M.D.L. S.r.l. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
Same manufacturer · M.D.L. S.r.l.
See all →- HighBiopsy Needle Recall Due to Compromised Sterility Assurance
FDA (Devices) · 2021-09-29
- HighSoft Tissue Biopsy Needles Recalled for Potential Sterility Compromise
FDA (Devices) · 2021-09-29
- HighMammary Nodule Localization Devices Recalled for Sterility Assurance Issues
FDA (Devices) · 2021-09-29
- HighGeneral Manual Surgical Instruments Recalled Due to Compromised Sterility Assurance
FDA (Devices) · 2021-09-29
Same hazard · sterility compromise
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMedline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
Similar recalls
- HighAngiotech Recalls Bone Marrow Biopsy Needles Due to Sterile Seal Defect
FDA (Devices) · 2019-02-13
- ModerateBone Marrow Biopsy Needle Recall Due to Sterile Seal Manufacturing Issue
FDA (Devices) · 2019-02-13
- HighArgon Medical Devices Recalls Bone Marrow Aspiration Needles Due to Sterility Risk
FDA (Devices) · 2015-07-29
- HighMedtronic Recalls Biopsy Needle Kits Due to Sterility Control Issues
FDA (Devices) · 2014-11-26
- HighArgon Medical Devices Recalls T-Lok Bone Marrow Biopsy Needles
FDA (Devices) · 2015-07-29
- HighAngiotech Recalls Bone Marrow Needles Due to Sterile Seal Manufacturing Issue
FDA (Devices) · 2019-02-13