The Recall Desk
HighFDA (Devices)·Z-2489-2021·Announced 2021-09-29

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.

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: 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.
Category
Medical Device — Surgical biopsy needle
Hazard
  • sterility-compromise

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.

Related recalls

Same category