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.
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 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.
- Hazard
- Affected units
- 4,120
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.
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
- HighBone Marrow Biopsy Needles Recalled for Sterility Assurance Concerns
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
- HighSurgical Instrument Service And Savings Recalls 73 Medical Devices with Compromised Sterile Seals
FDA (Devices) · 2013-07-10
- HighMedline Surgical Device Kits Recalled Due to Sterilization Equipment Calibration Issues
FDA (Devices) · 2026-05-13
- HighGeneral Laparoscopic Pack Recall Due to Unconfirmed Sterilization
FDA (Devices) · 2025-03-26
- ModerateSurgical Instrument Recall Due to Compromised Sterile Seal
FDA (Devices) · 2013-07-10
- HighMedline Convenience Kits General Closure sterilization calibration issue
FDA (Devices) · 2026-05-13
- SevereMedline Recalls Surgical Convenience Kits Over Sterilization Calibration Issues
FDA (Devices) · 2026-02-25