CLASS II Device recall · Reported 13 Feb 2019 · FDA Enforcement Report
"J" Type Bone Marrow Needle recalled by Angiotech (Manan Medical
Angiotech (Manan Medical Products, Inc.) is recalling "J" Type Bone Marrow Needle, distributed nationwide in the US. The recall was initiated on 18 Dec 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0814-2019
- FDA event ID
- 81968
- Recalling firm
- Angiotech (Manan Medical Products, Inc.), Wheeling, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Dec 2018
- FDA classified
- 7 Feb 2019
- Reported
- 13 Feb 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 18 Dec 2018 | Recall initiated by company | |
| 7 Feb 2019 | Classified by FDA | +51 days |
| 13 Feb 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
"J" Type Bone Marrow Needle 11ga x 10 cm - Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.
Where it was distributed
Worldwide distribution - US Nationwide in the states of New Jersey, and countries of Mexico and South Korea.
Questions about this recall
Why was it recalled?
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
Which lots are affected?
Model Number IMKBMN-11R-10-X, Lot Numbers LJUE, LEAC, LFKX; Model Number IMKBMN-11R-10, Lot Numbers LK0J, LEHU
Where was it sold?
Worldwide distribution - US Nationwide in the states of New Jersey, and countries of Mexico and South Korea.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
6 other products · FDA event 81968This product is part of a recall event; the main page for the event is Aguja de Aspiracion con Profundidad Ajustable Tipo I recalled.
More recalls from Angiotech (Manan Medical Products, Inc.)
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Double Diamond J Type Bone Marrow Needle & Marrow recalled | Angiotech (Manan Medical Products, Inc.) | Sterility | Nationwide |
| Device | CLASS II | J Type Bone Marrow Needle recalled by Angiotech (Manan Medical | Angiotech (Manan Medical Products, Inc.) | Sterility | Nationwide |
| Device | CLASS II | Aguja de Aspiration con Profundidad Ajustable Tipo I recalled | Angiotech (Manan Medical Products, Inc.) | Sterility | Nationwide |
| Device | CLASS II | J Type Bone Marrow Needle recalled by Angiotech (Manan Medical | Angiotech (Manan Medical Products, Inc.) | Sterility | Nationwide |
| Device | CLASS II | Aguja para Biopsia Tipo Medula Osea Ergonomica recalled | Angiotech (Manan Medical Products, Inc.) | Sterility | Nationwide |
Other Surgical Instruments recalls
All 3,809| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: IV Start KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Other | Nationwide |