Baxter Healthcare Corporation: Medical Device Recall in 2024 - (Recall #: Z-2321-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Patient Use (SPU) Circuit kit for Volara. Intermittent positive pressure breathing device.

Product Classification:

Class I

Date Initiated: May 30, 2024

Date Posted: July 24, 2024

Recall Number: Z-2321-2024

Event ID: 94713

Reason for Recall:

Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. The handset plug is required to ensure proper operation and ventilator gas flow.

Status: Ongoing

Product Quantity: 58,220 units

Code Information:

Product Codes: M08473/M08474; Lot numbers: 2171WA, 2237WA, 2238WA, 2241WA, 2242WA, 2243WA, 2244WA, 2249WA, 2250WA, 2251WA, 2285WA, 2286WA, 2290WA, 2297WA, 2298WA, 2299WA, 2307WA, 2308WA, 2311WA, 2332WA, 2333WA, 2341WA, 2342WA, 2349WA, 2355WA, 2356WA, 2357WA, 2363WA, 2364WA, 3019WA, 3061WA, 3067WA, 3068WA, 3069WA, 3072WA, 3073WA, 3074WA, 3080WA, 3081WA, 3094WA, 3095WA, 3096WA, 3100WA, 3101WA, 3102WA, 3103WA, 3109WA, 3110WA, 3111WA, 3123WA, 3124WA, 3152WA, 3156WA, 3157WA, 3158WA, 3213WA, 3214WA, 3215WA, 3219WA, 3240WA, 3241WA, 3268WA, 3270WA, 3271WA, 3272WA, 3297WA, 3298WA, 3299WA, 3300WA, 3303WA, 3304WA, 3305WA, 3306WA, 3310WA, 3311WA, 3313WA, 3326WA, 3327WA, 3328WA, 3331WA.

Distribution Pattern:

Nationwide distribution. International distribution to Canada, France, and Germany.

Voluntary or Mandated:

Voluntary: Firm initiated