Z-1086-2008

APNEA monitor accessories under the following brand names: a) SM 2 PS/PSL, Prof. Operators Manual, NL-NL...

Name: Z-1086-2008 APNEA monitor accessories under the following brand names: a) SM 2 PS/PSL, Prof. Operators Manual, NL-NL...
Creator: Respironics, Inc.
Published: 2007-10-15
License: https://open.fda.gov/license/

Respironics, Inc. / initiated 2007-10-15 / Terminated / root cause: manufacturing process

FDA source

Respironics, Inc. began a recall of APNEA 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... on 2007-10-15. The reason FDA records is "Foreign material: Glass fragments may present in the plastic bag material used to ship components". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1086-2008
Status: Terminated
Initiated: 2007-10-15
Posted: 2008-04-24
Terminated: 2009-09-01
Recalling firm: Respironics, Inc.
Product: APNEA 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 1030194; and c) Smartmonitor 2 with modem, PCMCIA model number 4003. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
Product code: NPF Monitor, Apnea, Home Use
Reason for recall: Foreign material: Glass fragments may present in the plastic bag material used to ship components.
Root cause tag: manufacturing process
FDA root cause: Environmental control
Action: The recalling firm issued a Recall Notification dated 10/18/07 to its customers. Replacement products were to be sent.
Quantity in commerce: 20950 units
Distribution: The products were shipped nationwide to medical facilities.
Product codes and lots: Lot Numbers 071010, 071011, and 071012.

Product code NPF

K061256Class IISmartmonitor 2PsRespironics, Inc. / cleared 2006-08-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)