Respironics, Inc. Non-continuous ventilator accessories under the following brand names: a) Adult ECG Electrodes model number 1016360; b) O2 Enrichment Attachment BX 10 model number 312010; c) O2 Enrichment Attachment Single model number 312710; d) Alice 5, Domestic model number 1017226; e) BIPAP Auto M.W/Humid, W/SmartCard, CA model number CA701HS; f) BIPAP Auto M.W/Humid, W/SmartCard, US model number DS700HS; g) BIPAP Auto M, W/SmartCard, US model number DS700S; h) BIPAP Auto SV W/SmartCard Dom Core model numbe Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Non-continuous ventilator accessories under the following brand names: a) Adult ECG Electrodes model number 1016360; b) O2 Enrichment Attachment BX 10 model number 312010; c) O2 Enrichment Attachment Single model number 312710; d) Alice 5, Domestic model number 1017226; e) BIPAP Auto M.W/Humid, W/SmartCard, CA model number CA701HS; f) BIPAP Auto M.W/Humid, W/SmartCard, US model number DS700HS; g) BIPAP Auto M, W/SmartCard, US model number DS700S; h) BIPAP Auto SV W/SmartCard Dom Core model numbe
Brand
Respironics, Inc.
Lot Codes / Batch Numbers
Lot Numbers 071010, 071011, and 071012.
Products Sold
Lot Numbers 071010, 071011, and 071012.
Respironics, Inc. is recalling Non-continuous ventilator accessories under the following brand names: a) Adult ECG Electrodes model due to Foreign material: Glass fragments may present in the plastic bag material used to ship components.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Foreign material: Glass fragments may present in the plastic bag material used to ship components.
Recommended Action
Per FDA guidance
The recalling firm issued a Recall Notification dated 10/18/07 to its customers. Replacement products were to be sent.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026