Severity
Critical
CriticalClass IOngoing
FDA Devices recall · Reported June 11, 2025
Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen Tubing, REF CPRM1116F
Affected lots were manufactured with B/V Filter incorrectly attached to the wrong port (patient port instead of the exhalation port). If not noticed prior to patient use, there wo…
SunMed Holdings, LLC recalled Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 … - a critical-severity action.
Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 … was recalled by SunMed Holdings, LLC in June 11, 2025. Reason: Affected lots were manufactured with B/V Filter incorrectly attached to the wrong port (patient port instead …. Check the official notice for the remedy. Verify recall #Z-1814-2025 with the FDA Devices before acting.
The recall
SunMed Holdings, LLC issued this critical-severity FDA Devices recall-Affected lots were manufactured with B/V Filter incorrectly attached to the wrong port (patient port instead ….
- Critical
- severity level
- 11K units
- affected scope
- Class I
- classification
- June 11, 2025
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1814-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1814-2025) was formally reported on June 11, 2025, with the manufacturer initiating the action on May 1, 2025. It is classified under Critical severity (Class I), with a current status of Ongoing. SunMed Holdings, LLC is listed as the recalling firm, operating out of Grand Rapids, MI. Federal records list the affected scope as 11,358.
The documented reason for this recall is: Affected lots were manufactured with B/V Filter incorrectly attached to the wrong port (patient port instead of the exhalation port). If not noticed prior to patient use, there would be interruption or delay in patient … Distribution data in the federal record shows the product reached: US Nationwide distribution via Medline.. 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
11,358
Related Recalls
6
3 from same agency
Product description
Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen Tubing, REF CPRM1116F
Reason for recall
Affected lots were manufactured with B/V Filter incorrectly attached to the wrong port (patient port instead of the exhalation port). If not noticed prior to patient use, there would be interruption or delay in patient resuscitation, which may lead to life threatening consequences, including hypoxia, hypercapnia, organ failure, and death.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-1814-2025 |
| Date reported | June 11, 2025 |
| Date initiated | May 1, 2025 |
| Recalling firm | SunMed Holdings, LLC |
| Firm location | Grand Rapids, MI |
| Affected scope | 11,358 |
| Distribution | US Nationwide distribution via Medline. |
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-1814-2025) 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? ▼
Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen Tubing, REF CPRM1116F. Recalled by SunMed Holdings, LLC. Units affected: 11,358.
Why was this product recalled? ▼
Affected lots were manufactured with B/V Filter incorrectly attached to the wrong port (patient port instead of the exhalation port). If not noticed prior to patient use, there would be interruption or delay in patient resuscitation, which may lead to life threatening consequences, including hypoxia, hypercapnia, organ failure, and death.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 11, 2025. Severity: Critical. Recall number: Z-1814-2025.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution via Medline..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1814-2025) 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 June 11, 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.