Respire Medical Recalls Pink Series EF+ Device Due to Breakage Risk
Respire Medical recalls one Respire Pink Series EF+ oral sleep apnea device (Serial No. 50837) due to potential breakage during use.
Use caution until it’s fixed
Potential for device breakage during use
Contact the company
What happened, in plain English
Respire Medical is recalling a single Respire Pink Series EF+ Oral Sleep Apnea Device with serial number 50837 because it may break while being used. The company has not yet provided a remedy or instructions for what owners should do with the device. This recall was issued on September 1, 2017, and affects units distributed nationwide in the US. Read more at govinfonow.com/recall/73078-respire-pink-series-ef-oral-sleep-apnea-device-breakage-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/73078-respire-pink-series-ef-oral-sleep-apnea-device-breakage-risk · Updated October 13, 2026 · FDA enforcement record: FDA #Z-1947-2018
Cite this page
“Respire Medical Recalls Pink Series EF+ Device Due to Breakage Risk.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/73078-respire-pink-series-ef-oral-sleep-apnea-device-breakage-risk. Based on FDA recall #Z-1947-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1947-2018%22&limit=1).
Why it’s dangerous
The primary hazard is that the device has the potential to break during use. While the record does not specify the exact nature of the injury, a broken medical device used for sleep apnea could pose safety risks to the user while operating.
Who’s affected
Owners of the specific Respire Pink Series EF+ Oral Sleep Apnea Device with serial number 50837. Users of this medical device are at risk if the unit breaks during normal operation.
How to tell if you have this one
Check if you own a Respire Pink Series EF+ Oral Sleep Apnea Device and verify if the serial number is exactly 50837. The product was distributed nationwide in the US.
- Brand
Respire Medical- Category
Medical device
All 5 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
US nationwide distribution.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1947-2018 | Respire Pink Series EF+ Oral Sleep Apnea Device.; Serial Number: 50837 | 1 unit |
| Z-1948-2018 | Respire Pink+ Hard/Soft Oral Sleep Apnea Device; Serial Numbers: 51366, 51439, 51368, 51577, 51303, 52409, 51985, 51796, 51709, 51744, 51560, 51321, 51545, 51437, 51571, 51576, 51438, 51566, 51509, 51629, 51502, 51409, 51307, 51218, 51154, 51001, 51220, 51153 & 50807 | 29 units |
| Z-1949-2018 | Respire Pink+ Hard Oral Sleep Apnea Device; Serial Numbers: 51447, 51460, 51612, 51318, 51320, 51839, 51714, 51909, 51720, 51397, 51498, 51413, 51581, 51479, 51503, 51496, 51163, 51084, 50472, 46747, 46125, 46000, 46101, 46268 & 52634 | 25 units |
| Z-1950-2018 | Respire Pink H/S Oral Sleep Apnea Device; Serial Number: 46299 | N/A |
| Z-1951-2018 | Respire Pink H/S Oral Sleep Apnea Device; Serial Number: 50317 | N/A |
What to do — step by step
Contact Manufacturer
Reach out to Respire Medical for further instructions, as no specific remedy or return process is currently listed in the record.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.3 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1947-2018 (September 1, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1947-2018 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 13, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.