Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported November 15, 2023
AMO ADMINISTRATION SET, Article No. 7A3817, REF OM2505191, for ophthalmologic use.
Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and hea…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
B. Braun Medical, Inc. recalled AMO ADMINISTRATION SET, Article No. 7A3817, REF OM2505191, for ophthalmologic use. - a moderate-severity action.
AMO ADMINISTRATION SET, Article No. 7A3817, REF OM2505191, for ophthalmologic use. was recalled by B. Braun Medical, Inc. in November 15, 2023. Reason: Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase ris…. Check the official notice for the remedy. Verify recall #Z-0130-2024 with the FDA Devices before acting.
The recall
B. Braun Medical, Inc. issued this moderate-severity FDA Devices recall-Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase ris….
- Moderate
- severity level
- 32K units
- affected scope
- Class II
- classification
- November 15, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0130-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0130-2024) was formally reported on November 15, 2023, with the manufacturer initiating the action on September 26, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. B. Braun Medical, Inc. is listed as the recalling firm, operating out of Allentown, PA. Federal records list the affected scope as 32,000.
The documented reason for this recall is: Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to hazardous medication.… Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide and the countries of Canada and Singapore.. 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 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
32,000
Related Recalls
6
3 from same agency
Product description
AMO ADMINISTRATION SET, Article No. 7A3817, REF OM2505191, for ophthalmologic use.
Reason for recall
Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to hazardous medication. There is also the potential for life-threatening situations to occur requiring additional medical intervention.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0130-2024 |
| Date reported | November 15, 2023 |
| Date initiated | September 26, 2023 |
| Recalling firm | B. Braun Medical, Inc. |
| Firm location | Allentown, PA |
| Affected scope | 32,000 |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada and Singapore. |
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-0130-2024) 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? ▼
AMO ADMINISTRATION SET, Article No. 7A3817, REF OM2505191, for ophthalmologic use.. Recalled by B. Braun Medical, Inc.. Units affected: 32,000.
Why was this product recalled? ▼
Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to hazardous medication. There is also the potential for life-threatening situations to occur requiring additional medical intervention.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 15, 2023. Severity: Moderate. Recall number: Z-0130-2024.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - US Nationwide and the countries of Canada and Singapore..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0130-2024) 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 November 15, 2023. 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.