Device recall: "J" Type Bone Marrow Needle 11ga x 10 cm - Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspirat
FDA enforcement event 81968 is a device recall by Angiotech (Manan Medical Products, Inc.) of Wheeling, IL, initiated 18 Dec 2018 and classified Class II, with 7 product records.
FDA defines Class II as 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. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 23 Aug 2020. Initiation: voluntary: firm initiated. This is the only enforcement event on this register for Angiotech (Manan Medical Products, Inc.).
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Angiotech (Manan Medical Products, Inc.), Wheeling, IL.
Reason for recall
"Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line"
Distribution
"Worldwide distribution - US Nationwide in the states of New Jersey, and countries of Mexico and South Korea."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0814-2019 | "J" Type Bone Marrow Needle 11ga x 10 cm - Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration. | 9,900 units | Class II | Terminated | 13 Feb 2019 |
| Z-0815-2019 | J Type Bone Marrow Needle 13ga x 10 cm- Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration. | 1,260 units | Class II | Terminated | 13 Feb 2019 |
| Z-0816-2019 | J Type Bone Marrow Needle 13ga x 6cm - Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration. | 180 units | Class II | Terminated | 13 Feb 2019 |
| Z-0817-2019 | Double Diamond J Type Bone Marrow Needle & Marrow Extraction Cannula 11ga x 10cm 14MTWX x 12.5 cm | 500 units | Class II | Terminated | 13 Feb 2019 |
| Z-0818-2019 | Aguja de Aspiracion con Profundidad Ajustable Tipo I 16ga x 5 cm- Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration. | 1,404 units | Class II | Terminated | 13 Feb 2019 |
| Z-0819-2019 | Aguja para Biopsia Tipo Medula Osea Ergonomica 11ga x 10cm | 2,502 units | Class II | Terminated | 13 Feb 2019 |
| Z-0820-2019 | Aguja de Aspiration con Profundidad Ajustable Tipo I 15ga x 5 cm - Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration. | 504 units | Class II | Terminated | 13 Feb 2019 |
Context
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution - US Nationwide in the states of New Jersey, and countries of Mexico and South Korea."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 23 Aug 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.