CLASS II Device recall · Reported 24 May 2017 · FDA Enforcement Report

Spacelabs Healthcare Arkon Anesthesia Delivery System recalled

Del Mar Reynolds Medical is recalling Spacelabs Healthcare Arkon Anesthesia Delivery System is intended for use in the hospital, distributed in Florida, Louisiana, Mississippi, North Carolina, South Carolina, Wyoming. The recall was initiated on 14 Apr 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes*********the serial numbers and part numbers of units distributed in the US ********* Absorber Adapter Assembly Service Kit part number: 050-9045-00. Devices serial numbers: ARKN-000395, ARKN-000396, ARKN-000397, ARKN-000398, ARKN-000399, ARKN-000400, ARKN-000401, ARKN-000402, ARKN-000403, ARKN-000404, ARKN-000405, ARKN-000406, ARKN-000407, ARKN-000408, ARKN-000409, ARKN-000410, ARKN-000411, ARKN-000412, and ARKN-000413. *********the serial numbers of units distributed international ************************** ARKN-000375, ARKN-000414, ARKN-000415, ARKN-000416, ARKN-000417, ARKN-000418, ARKN-000419, ARKN-000420, ARKN-000421, ARKN-000422, and ARKN-000423.

Quantity recalled62 total (US= 19 devices and 32 kits; International = 11 devices)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2093-2017
FDA event ID: 77019
Recalling firm: Del Mar Reynolds Medical, Hertford
Classification: Class II
Status: Terminated
Recall initiated: 14 Apr 2017
FDA classified: 16 May 2017
Reported: 24 May 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

14 Apr 2017	Recall initiated by company
16 May 2017	Classified by FDA	+32 days
24 May 2017	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Reports of the Canister Carrier breaking during absorbent exchange or during anesthesia machine transit, causing a leak in the breathing circuit, which could cause hypoventilation in the patient.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Spacelabs Healthcare Arkon Anesthesia Delivery System is intended for use in the hospital environment and operating room. Absorber Adapter Assembly Service Kit, part number: 050-9045-00. Absorber Adapter Assembly, part number: 650-1648-01. Arkon Absorber Canister Carrier, part number: 380-0916-01.

Where it was distributed

US distribution in FL, LA, MS, NC, NC, SC and WY and Internationally to Panama and United Kingdom.

Florida Louisiana Mississippi North Carolina South Carolina Wyoming

Questions about this recall

Why was it recalled?

Reports of the Canister Carrier breaking during absorbent exchange or during anesthesia machine transit, causing a leak in the breathing circuit, which could cause hypoventilation in the patient.

Which lots are affected?

*********the serial numbers and part numbers of units distributed in the US ********* Absorber Adapter Assembly Service Kit part number: 050-9045-00. Devices serial numbers: ARKN-000395, ARKN-000396, ARKN-000397, ARKN-000398, ARKN-000399, ARKN-000400, ARKN-000401, ARKN-000402, ARKN-000403, ARKN-000404, ARKN-000405, ARKN-000406, ARKN-000407, ARKN-000408, ARKN-000409, ARKN-000410, ARKN-000411, ARKN-000412, and ARKN-000413. *********the serial numbers of units distributed international ************************** ARKN-000375, ARKN-000414, ARKN-000415, ARKN-000416, ARKN-000417, ARKN-000418, ARKN-000419, ARKN-000420, ARKN-000421, ARKN-000422, and ARKN-000423.

Where was it sold?

US distribution in FL, LA, MS, NC, NC, SC and WY and Internationally to Panama and United Kingdom.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Del Mar Reynolds Medical

All 8

Reported	Class	Recall	Company	Reason	Where
22 Mar 2017Device	CLASS II	Arkon Anesthesia Delivery System recalled by Del Mar Reynolds Medical	Del Mar Reynolds Medical	Device Malfunction	Nationwide
29 Apr 2015Device	CLASS II	Spacelabs Pediatric Flow Sensor Kit, PN recalled	Del Mar Reynolds Medical	Labeling Errors	LA, NC, WA
23 Apr 2014Device	CLASS I	SpaceLabs Arkon Anesthesia Delivery System recalled	Del Mar Reynolds Medical	Device Malfunction	Nationwide
27 Nov 2013Device	CLASS I	CAS I/II Absorbers that are parts of the BleaseSirius recalled	Del Mar Reynolds Medical	Other	Nationwide
31 Jul 2013Device	CLASS II	Spacelabs Arkon Anesthesia Workstation recalled	Del Mar Reynolds Medical	Device Malfunction	SC

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide