Draegerwerk Ag & Co. Kgaa: Medical Device Recall in 2024 - (Recall #: Z-0971-2024)

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:

Atlan, Gas Machine for Anesthesia or Analgesia, Catalog numbers 8621500 (Atlan A350) and 8621600 (Atlan A350 XL)

Product Classification:

Class II

Date Initiated: November 17, 2023

Date Posted: February 7, 2024

Recall Number: Z-0971-2024

Event ID: 93544

Reason for Recall:

Internal backup battery may fail spontaneously while the Atlan is being operated without AC mains supply, resulting in unexpected shutdown of the device while running on batteries.

Status: Ongoing

Product Quantity: 50 imported to US, not distributed to end users

Code Information:

UDI-DI: 04048675556176 (Atlan A350) 04048675556183 (Atlan A350 XL) Lots: ASSH-0220 ASSH-0221 ASSH-0222 ASSH-0223 ASSH-0224 ASSH-0225 ASSH-0226 ASSH-0227 ASSH-0228 ASSH-0229 ASSH-0230 ASSH-0231 ASSH-0232 ASSH-0233 ASSH-0234 ASSH-0235 ASSH-0236 ASSH-0237 ASSH-0238 ASSH-0239 ASSH-0240 ASSH-0241 ASSH-0242 ASSH-0243 ASSH-0244 ASSH-0245 ASSH-0246 ASSH-0247 ASSH-0248 ASSH-0249 ASSH-0250 ASSH-0251 ASSH-0252 ASSH-0253 ASSH-0254 ASSL-0347 ASSL-0347 ASSL-0349 ASSL-0350 ASSL-0351 ASSL-0352 ASSL-0353 ASSL-0354 ASSL-0355 ASSL-0356 ASSL-0357 ASSL-0358 ASSL-0359 ASSL-0360 ASSL-0361

Distribution Pattern:

No devices were distributed to end-users (customers) in the US. All devices are currently under the direct control of Draeger, Inc.

Voluntary or Mandated:

Voluntary: Firm initiated