Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported February 13, 2019
J Type Bone Marrow Needle 13ga x 10 cm- Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.
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
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Angiotech (Manan Medical Products, Inc.) recalled J Type Bone Marrow Needle 13ga x 10 cm- Product Usage: Manual surgical instruments for … - a moderate-severity action.
J Type Bone Marrow Needle 13ga x 10 cm- Product Usage: Manual surgical instruments for … was recalled by Angiotech (Manan Medical Products, Inc.) in February 13, 2019. Reason: Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of …. Check the official notice for the remedy. Verify recall #Z-0815-2019 with the FDA Devices before acting.
The recall
Angiotech (Manan Medical Products, Inc.) issued this moderate-severity FDA Devices recall-Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of ….
- Moderate
- severity level
- 1K units
- affected scope
- Class II
- classification
- February 13, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0815-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0815-2019) was formally reported on February 13, 2019, with the manufacturer initiating the action on December 18, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Angiotech (Manan Medical Products, Inc.) is listed as the recalling firm, operating out of Wheeling, IL. Federal records list the affected scope as 1,260 units.
The documented reason for this recall is: 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 data in the federal record shows the product reached: Worldwide distribution - US Nationwide in the states of New Jersey, and countries of Mexico and South Korea.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,422 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1,260 units
Related Recalls
6
0 from same agency
Product description
J Type Bone Marrow Needle 13ga x 10 cm- Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.
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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0815-2019 |
| Date reported | February 13, 2019 |
| Date initiated | December 18, 2018 |
| Recalling firm | Angiotech (Manan Medical Products, Inc.) |
| Firm location | Wheeling, IL |
| Affected scope | 1,260 units |
| Distribution | Worldwide distribution - US Nationwide in the states of New Jersey, and countries of Mexico and South Korea. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0815-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
J Type Bone Marrow Needle 13ga x 10 cm- Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.. Recalled by Angiotech (Manan Medical Products, Inc.). Units affected: 1,260 units.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on February 13, 2019. Severity: Moderate. Recall number: Z-0815-2019.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - US Nationwide in the states of New Jersey, and countries of Mexico and South Korea..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0815-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported February 13, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.