The Recall Desk
HighFDA (Devices)·Z-2493-2021·Announced 2021-09-29

General Manual Surgical Instruments Recalled Due to Compromised Sterility Assurance

M.D.L. S.r.l. is recalling approximately 4,120 units of general manual surgical instruments nationwide due to compromised sterility assurance. Healthcare facilities should verify lot numbers and quarantine affected instruments immediately.

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 recall involving surgical instruments where sterility assurance may be compromised. No illnesses or injuries have been reported. Per the rubric, this qualifies as a high-risk product where injury has not yet been reported, warranting a score of 3.

Plain-English summary

M.D.L. S.r.l. is recalling general manual surgical instruments distributed nationwide. The affected instruments include 23 different models (including MGC1413, MGP1410, PC1610, PM1410, and VE1410) with specific lot numbers including 0817A, 5216C, 3620D, 1217B, and 1417A. Approximately 4,120 units are involved in this recall.

The sterility assurance of these instruments may be compromised. Surgical instruments that cannot be guaranteed sterile pose a direct risk to patients undergoing surgical procedures.

Healthcare facilities and surgical centers that have received these instruments should immediately verify the model and lot numbers against the recall notice. Any instruments matching the affected models and corresponding lot numbers should be removed from service and quarantined. Healthcare providers are advised to contact M.D.L. S.r.l. or the FDA for instructions on returning or replacing the affected instruments.

The recalled product

Product
General Manual surgical instrument
Manufacturer
M.D.L. S.r.l.
Category
Medical Device — Surgical Instruments
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 MGC1413
  • Lot Numbers: 0817A Model MGC1825
  • Lot Numbers: 0817A Model MGP1410
  • Lot Numbers: 5216C Model MGP1412
  • Lot Numbers: 5216C Model MGP1612
  • Lot Numbers: 5216C Model MGP1820
  • Lot Numbers: 5216C Model MGP1825
  • Lot Numbers: 0817A Model PC1610
  • Lot Numbers: 3620D Model PC1810
  • Lot Numbers: 3620D Model PC1815
  • Lot Numbers: 1217B Model PM14075
  • Lot Numbers: 5216C Model PM1410
  • Lot Numbers: 3620D Model PM14114
  • Lot Numbers: 5216C Model PM1415
  • Lot Numbers: 5216C Model PM16075
  • Lot Numbers: 5216C Model PM1610
  • Lot Numbers: 3620D Model PM16114
  • Lot Numbers: 5216C Model PM1615
  • Lot Numbers: 5216C Model PM18075
  • Lot Numbers: 5216C Model PM18114

Distribution

Distributed nationwide across the United States.

Related recalls

Same category