Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported March 16, 2022
Dispensing Pins for Air Inlet Filter, Product Catalog No. 412005, DP2500 Dispensing Pin W/Valve. A valve for aspiration or injection of medication or enteral feeding solution from inverted multi-dose vials.
This lot may have an elevated risk of leakage from the Air-Inlet Filter of the device. Leakage of the Air-Inlet Filter may increase the risk of decreasing the dose of medication d…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
B. Braun Medical, Inc. recalled Dispensing Pins for Air Inlet Filter, Product Catalog No. 412005, DP2500 Dispensing Pin … - a moderate-severity action.
Dispensing Pins for Air Inlet Filter, Product Catalog No. 412005, DP2500 Dispensing Pin … was recalled by B. Braun Medical, Inc. in March 16, 2022. Reason: This lot may have an elevated risk of leakage from the Air-Inlet Filter of the device. Leakage of the Air-Inl…. Check the official notice for the remedy. Verify recall #Z-0727-2022 with the FDA Devices before acting.
The recall
B. Braun Medical, Inc. issued this moderate-severity FDA Devices recall-This lot may have an elevated risk of leakage from the Air-Inlet Filter of the device. Leakage of the Air-Inl….
- Moderate
- severity level
- Class II
- classification
- March 16, 2022
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0727-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0727-2022) was formally reported on March 16, 2022, with the manufacturer initiating the action on January 31, 2022. 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 15,550 ea (US); 900 ea (OUS).
The documented reason for this recall is: This lot may have an elevated risk of leakage from the Air-Inlet Filter of the device. Leakage of the Air-Inlet Filter may increase the risk of decreasing the dose of medication delivered to the patient, cause delays in… Distribution data in the federal record shows the product reached: US Nationwide distribution in the states of AZ, CA, FL, LA, MI, MO, MS, NC, NJ, OH, PA, TN, TX, and UT. The country of Canada.. 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
15,550 ea (US); 900 ea (OUS)
Related Recalls
6
3 from same agency
Product description
Dispensing Pins for Air Inlet Filter, Product Catalog No. 412005, DP2500 Dispensing Pin W/Valve. A valve for aspiration or injection of medication or enteral feeding solution from inverted multi-dose vials.
Reason for recall
This lot may have an elevated risk of leakage from the Air-Inlet Filter of the device. Leakage of the Air-Inlet Filter may increase the risk of decreasing the dose of medication delivered to the patient, cause delays in treatment due to the need to replace the device or may cause contamination of the fluid path that can lead to bloodstream infection.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0727-2022 |
| Date reported | March 16, 2022 |
| Date initiated | January 31, 2022 |
| Recalling firm | B. Braun Medical, Inc. |
| Firm location | Allentown, PA |
| Affected scope | 15,550 ea (US); 900 ea (OUS) |
| Distribution | US Nationwide distribution in the states of AZ, CA, FL, LA, MI, MO, MS, NC, NJ, OH, PA, TN, TX, and UT. The country of Canada. |
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-0727-2022) 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? ▼
Dispensing Pins for Air Inlet Filter, Product Catalog No. 412005, DP2500 Dispensing Pin W/Valve. A valve for aspiration or injection of medication or enteral feeding solution from inverted multi-dose vials.. Recalled by B. Braun Medical, Inc.. Units affected: 15,550 ea (US); 900 ea (OUS).
Why was this product recalled? ▼
This lot may have an elevated risk of leakage from the Air-Inlet Filter of the device. Leakage of the Air-Inlet Filter may increase the risk of decreasing the dose of medication delivered to the patient, cause delays in treatment due to the need to replace the device or may cause contamination of the fluid path that can lead to bloodstream infection.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 16, 2022. Severity: Moderate. Recall number: Z-0727-2022.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution in the states of AZ, CA, FL, LA, MI, MO, MS, NC, NJ, OH, PA, TN, TX, and UT. The country of Canada..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0727-2022) 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.
Nearby Recalls in This Category
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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 March 16, 2022. 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.