Non-continuous ventilator accessories under the following… recallZ-1069-2008 · Respironics, Inc. · initiated Oct 15, 2007
Terminated All recalls posted in April 2008
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Respironics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Foreign material: Glass fragments may present in the plastic bag material used to ship components.
FDA root cause category: Environmental control
What the company is doing
The recalling firm issued a Recall Notification dated 10/18/07 to its customers. Replacement products were to be sent.
Recall details
- Recall number
- Z-1069-2008
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Oct 15, 2007
- Posted by the FDA
- Apr 24, 2008
- Recalling firm
- Respironics, Inc.
- Quantity
- 20950 units
- Product code
- BZD
- FDA submissions
- K021861, K052110
- Distribution
- The products were shipped nationwide to medical facilities.
Product description
Non-continuous ventilator accessories under the following brand names: a) REMStar Pro2 Domestic model number 1020923; b) REMStar Pro M, w/Humid w/Smartcard US model number DS400HS; c) REMStar Pro M w/Smartcard US model number DS400S; d) REMStar Pro/Plus Silencer Cap model number 1005962; e) REMStar Pro/Plus/Auto/Lite Pollen model number 1005964; f) REMStar Pro/Plus/Auto/Lite Pollen SNGL model number 1001389; g) REMStar Pro/Plus/Auto/Lite Ultrafine model number 1005945; and h) REMStar Pro/Plus/Auto/Lite Ultrafine Qty 1 model number 1039607. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
Code information (models, lots, serial numbers)
Lot Numbers 071010, 071011, and 071012.
Other devices under the same FDA submission
1 device cleared under K021861, K052110 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- REMstar REMstar Pro C-Flex+, System One 60 Series, ItalyRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 45545).
- Z-1086-2008 · TerminatedAPNEA monitor accessories under the following brand names: a) SM 2 PS/PSL, Prof. Operators Manual, NL-NL model number 1025422; b) SM 2/2 PS Europe Patient Cable, Metal model number…
- Z-1093-2008 · TerminatedLead Wire Pin/Socket 24 in 1 pr model number 9520. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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