Severity
Moderate
FDA Devices recall · Reported February 12, 2020
Potential for leakage at the joint between the blood filters and tubing
B. Braun Medical, Inc. recalled Safeline Y-Type Blood Set, Catalog Number V2500 - a moderate-severity action.
Safeline Y-Type Blood Set, Catalog Number V2500 was recalled by B. Braun Medical, Inc. in February 12, 2020. Reason: Potential for leakage at the joint between the blood filters and tubing. Check the official notice for the remedy. Verify recall #Z-0941-2020 with the FDA Devices before acting.
The recall
B. Braun Medical, Inc. issued this moderate-severity FDA Devices recall-Potential for leakage at the joint between the blood filters and tubing.
Sourced from official FDA Devices enforcement records. Verify recall #Z-0941-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-0941-2020) was formally reported on February 12, 2020, with the manufacturer initiating the action on November 20, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. B. Braun Medical, Inc. is listed as the recalling firm, operating out of Allentown, PA. Federal records list the affected scope as 19,500 units.
The documented reason for this recall is: Potential for leakage at the joint between the blood filters and tubing Distribution data in the federal record shows the product reached: US Nationwide. 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.
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 moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
19,500 units
Related Recalls
6
3 from same agency
Safeline Y-Type Blood Set, Catalog Number V2500
Potential for leakage at the joint between the blood filters and tubing
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0941-2020 |
| Date reported | February 12, 2020 |
| Date initiated | November 20, 2019 |
| Recalling firm | B. Braun Medical, Inc. |
| Firm location | Allentown, PA |
| Affected scope | 19,500 units |
| Distribution | US Nationwide |
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.
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.
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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 12, 2020. 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.