Bone Marrow Biopsy Needle Recall Due to Sterile Seal Manufacturing Issue
Angiotech is recalling 2,502 bone marrow biopsy needles due to a manufacturing issue affecting the sterile seal on blister trays.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The source text describes a manufacturing issue with the sterile seal but explicitly notes no reported illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Angiotech (Manan Medical Products, Inc.) is recalling 2,502 units of the Bone Marrow Biopsy Needle (Model UCIN-11-10, Lot LFDB). The recall is due to an internal manufacturing issue identified in the formation of the sterile seal on some of the blister trays for this product line.
The affected products were distributed worldwide, including nationwide in the United States (specifically New Jersey) and in Mexico and South Korea. The source text does not report any illnesses or injuries associated with this recall.
Healthcare providers and consumers should stop using the affected bone marrow biopsy needles and contact the recalling firm for further instructions.
The recalled product
- Product
- Aguja para Biopsia Tipo Medula Osea Ergonomica 11ga x 10cm
- Manufacturer
- Angiotech (Manan Medical Products, Inc.)
- Affected units
- 2,502
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 (2)
- Model Number UCIN-11-10
- Lot Number LFDB
Distribution
Part of a larger recall action
This product is one of 7 recalled by Angiotech (Manan Medical Products, Inc.) 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 7 products in this recall →Related recalls
Same manufacturer · Angiotech (Manan Medical Products, Inc.)
See all →- HighAngiotech Recalls Bone Marrow Needles Due to Sterile Seal Manufacturing Issue
FDA (Devices) · 2019-02-13
- HighBone Marrow Biopsy Needle Recall Due to Sterile Seal Manufacturing Issue
FDA (Devices) · 2019-02-13
- HighBone Marrow Biopsy Needle Recall Due to Sterile Seal Manufacturing Issue
FDA (Devices) · 2019-02-13
- 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
Same hazard · sterile seal defect
See all →- HighDaig Livewire Steerable Electrophysiology Catheter Sterile Seal Defect Recall
FDA (Devices) · 2026-05-20
- HighMedtronic Visualase Cooled Laser Applicator Sterile Seal Defect Recall
FDA (Devices) · 2022-11-23
- ModerateAngiotech Recalls Bone Marrow Biopsy Needles Due to Sterile Seal Defect
FDA (Devices) · 2019-02-13
Similar recalls
- HighBone Marrow Biopsy Needles Recalled for Sterility Assurance Concerns
FDA (Devices) · 2021-09-29
- HighArgon Medical Devices Recalls Bone Marrow Aspiration Needles Due to Sterility Risk
FDA (Devices) · 2015-07-29
- HighArgon Medical Devices Recalls T-Lok Bone Marrow Biopsy Needles
FDA (Devices) · 2015-07-29
- HighBecton Dickinson Recalls Jamshidi Bone Marrow Biopsy Needles Due to Sterility Concerns
FDA (Devices) · 2019-09-04
- HighBiopsy Needle Recall Due to Compromised Sterility Assurance
FDA (Devices) · 2021-09-29
- HighBPB medica Osteobell Explant Needle Recalled for Sterility Concerns
FDA (Devices) · 2021-05-26