Severity
Moderate
FDA Devices recall · Reported May 28, 2025
Due to a manufacturing defect IV catheter may have a hole in the septum, which may result in blood leakage from the septum during insertion, which may cause blood exposure or the …
Becton Dickinson Infusion Therapy Systems, Inc. recalled BD Cathena Safety IV Catheter BD Multiguard Technology 18 GA x 1.25 IN, REF: 386865; B… - a moderate-severity action.
BD Cathena Safety IV Catheter BD Multiguard Technology 18 GA x 1.25 IN, REF: 386865; B… was recalled by Becton Dickinson Infusion Therapy Systems, Inc. in May 28, 2025. Reason: Due to a manufacturing defect IV catheter may have a hole in the septum, which may result in blood leakage fr…. Check the official notice for the remedy. Verify recall #Z-1808-2025 with the FDA Devices before acting.
The recall
Becton Dickinson Infusion Therapy Systems, Inc. issued this moderate-severity FDA Devices recall-Due to a manufacturing defect IV catheter may have a hole in the septum, which may result in blood leakage fr….
Sourced from official FDA Devices enforcement records. Verify recall #Z-1808-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-1808-2025) was formally reported on May 28, 2025, with the manufacturer initiating the action on April 21, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. Becton Dickinson Infusion Therapy Systems, Inc. is listed as the recalling firm, operating out of Sandy, UT. Federal records list the affected scope as 262,800, a scale large enough to require multi-state distribution tracking.
The documented reason for this recall is: Due to a manufacturing defect IV catheter may have a hole in the septum, which may result in blood leakage from the septum during insertion, which may cause blood exposure or the need for a second IV to be placed - whic… Distribution data in the federal record shows the product reached: Worldwide - US Nationwide distribution in the states of IN, AL, CA, FL, TX, NJ, MO, NC, NY, OH, AZ, MN, MA, WA, OK, KS, MS, LA, MD, GA, TN, NM, PA and the country of CA.. 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
262,800
Related Recalls
6
3 from same agency
BD Cathena Safety IV Catheter BD Multiguard Technology 18 GA x 1.25 IN, REF: 386865; BD Cathena Safety IV Catheter 20GX1.00IN STRAIGHT BC, REF: 386803; BD Cathena Safety IV Catheter BD Multiguard Technology 20 GA x 1.00 IN, 386862
Due to a manufacturing defect IV catheter may have a hole in the septum, which may result in blood leakage from the septum during insertion, which may cause blood exposure or the need for a second IV to be placed - which may result in therapy delay.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1808-2025 |
| Date reported | May 28, 2025 |
| Date initiated | April 21, 2025 |
| Recalling firm | Becton Dickinson Infusion Therapy Systems, Inc. |
| Firm location | Sandy, UT |
| Affected scope | 262,800 |
| Distribution | Worldwide - US Nationwide distribution in the states of IN, AL, CA, FL, TX, NJ, MO, NC, NY, OH, AZ, MN, MA, WA, OK, KS, MS, LA, MD, GA, TN, NM, PA and the country of CA. |
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 May 28, 2025. 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.