Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported August 3, 2016
DIAMOND-FLEX CIRCULAR RETRACTOR, ANGLED, 40MM 5MM, Product Code 89-6114, Lot Code(s): 878971; 879366; 879404, and Date Code: C16. Designed to retract or elevate organs and tissue to provide better visualization access.
BD, formerly CareFusion, has identified a potential risk associated with a weld failure which could result in the wire protruding thru the tip of the instrument when articulated. …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Carefusion 2200 Inc recalled DIAMOND-FLEX CIRCULAR RETRACTOR, ANGLED, 40MM 5MM, Product Code 89-6114, Lot Code(s): 878… - a critical-severity action.
DIAMOND-FLEX CIRCULAR RETRACTOR, ANGLED, 40MM 5MM, Product Code 89-6114, Lot Code(s): 878… was recalled by Carefusion 2200 Inc in August 3, 2016. Reason: BD, formerly CareFusion, has identified a potential risk associated with a weld failure which could result in…. Check the official notice for the remedy. Verify recall #Z-2212-2016 with the FDA Devices before acting.
The recall
Carefusion 2200 Inc issued this critical-severity FDA Devices recall-BD, formerly CareFusion, has identified a potential risk associated with a weld failure which could result in….
- Critical
- severity level
- 10 units
- affected scope
- Class I
- classification
- August 3, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2212-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2212-2016) was formally reported on August 3, 2016, with the manufacturer initiating the action on July 1, 2016. It is classified under Critical severity (Class I), with a current status of Terminated. Carefusion 2200 Inc is listed as the recalling firm, operating out of Vernon Hills, IL. Federal records list the affected scope as 10.
The documented reason for this recall is: BD, formerly CareFusion, has identified a potential risk associated with a weld failure which could result in the wire protruding thru the tip of the instrument when articulated. If this failure were to occur while in u… Distribution data in the federal record shows the product reached: Worldwide Distribution - US, including the states of WA and MD; and, the country of Japan.. 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, 3 from FDA Devices - 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 - 40,322 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 high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
10
Related Recalls
6
3 from same agency
Product description
DIAMOND-FLEX CIRCULAR RETRACTOR, ANGLED, 40MM 5MM, Product Code 89-6114, Lot Code(s): 878971; 879366; 879404, and Date Code: C16. Designed to retract or elevate organs and tissue to provide better visualization access.
Reason for recall
BD, formerly CareFusion, has identified a potential risk associated with a weld failure which could result in the wire protruding thru the tip of the instrument when articulated. If this failure were to occur while in use in a procedure it has the potential to damages tissue or organs
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-2212-2016 |
| Date reported | August 3, 2016 |
| Date initiated | July 1, 2016 |
| Recalling firm | Carefusion 2200 Inc |
| Firm location | Vernon Hills, IL |
| Affected scope | 10 |
| Distribution | Worldwide Distribution - US, including the states of WA and MD; and, the country of Japan. |
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-2212-2016) 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.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. 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? ▼
DIAMOND-FLEX CIRCULAR RETRACTOR, ANGLED, 40MM 5MM, Product Code 89-6114, Lot Code(s): 878971; 879366; 879404, and Date Code: C16. Designed to retract or elevate organs and tissue to provide better visualization access.. Recalled by Carefusion 2200 Inc. Units affected: 10.
Why was this product recalled? ▼
BD, formerly CareFusion, has identified a potential risk associated with a weld failure which could result in the wire protruding thru the tip of the instrument when articulated. If this failure were to occur while in use in a procedure it has the potential to damages tissue or organs
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 3, 2016. Severity: Critical. Recall number: Z-2212-2016.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US, including the states of WA and MD; and, the country of Japan..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2212-2016) 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 August 3, 2016. 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.