Soft Tissue Biopsy Needles Recalled for Potential Sterility Compromise
M.D.L. S.r.l. has recalled approximately 20,129 soft tissue biopsy needles 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: This is an FDA Class II medical device recall for biopsy needles with potential sterility compromise. No illnesses or injuries have been reported, but compromised sterility on invasive medical devices poses a significant risk of infection.
Plain-English summary
M.D.L. S.r.l. is recalling soft tissue biopsy needles nationwide due to potential compromise of sterility assurance. The recall affects approximately 20,129 units across multiple models distributed to healthcare facilities.
The recall includes numerous models in the MGK, PD, PD0PP, and TY series with specific lot numbers. Complete information on all affected models and lot numbers is available from the FDA and the manufacturer.
Healthcare facilities and practitioners should identify any affected needles in inventory by matching against the specific model and lot numbers. Do not use recalled devices for patient procedures. Contact M.D.L. S.r.l. or the FDA for information regarding replacement or proper disposal.
The recalled product
- Product
- Soft Tissue Biopsy Needles
- Manufacturer
- M.D.L. S.r.l.
- Affected units
- 20,129
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 MGK11210
- Lot Numbers: 5216C Model MGK11410
- Lot Numbers: 5216C
- 1217B
- 3620D Model MGK11413
- Lot Numbers: 5216C Model MGK11415
- Lot Numbers: 3620D Model MGK11610
- 3620D Model MGK11615
- Lot Numbers: 3620D Model MGK11616
- 1217B Model MGK11620
- Lot Numbers: 1617A Model MGK11810
- Lot Numbers: 5216C Model MGK11816
- Lot Numbers: 5216C Model MGK11820
- 4617 Model MGK11825
- Lot Numbers: 5216C
- 3620D
- 3620E Model PD01415
- Lot Numbers: 3620D
- 3620E Model PD01416
- 1417A Model PD01420
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
- 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
- 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
- HighMedtronic Recalls Biopsy Needle Kits Due to Sterility Control Issues
FDA (Devices) · 2014-11-26
- ModerateTerumo 30G Needle Recall Due to Potential Sterility Compromise
FDA (Devices) · 2019-07-31
- HighTerumo Medical Recalls 23G Needles Due to Potential Sterility Compromise
FDA (Devices) · 2019-07-31
- ModerateTerumo Sur-vet Needle Recall Due to Potential Sterility Compromise
FDA (Devices) · 2019-07-31
- ModerateCarefusion Recalls Jamshidi Needle Biopsy Devices Due to Packaging Integrity Concerns
FDA (Devices) · 2018-04-25
- HighSterile Procedural Trays Recalled for Potential Blade Puncture
FDA (Devices) · 2023-02-15