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 recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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, 6 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 - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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.
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? ▼
Why was this product recalled? ▼
Which agency issued this recall? ▼
Where was the recalled product distributed? ▼
Should I stop using a recalled medication or medical device? ▼
Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Critical), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
Compare this recall with GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VS… → · All Medical Devices recalls
Methodology · Corrections · Archive as of August 2026