Draegerwerk Ag & Co. Kgaa Dragerwerk Ag & Co. Kgaa Accounts Payable Moislinger Allee Atlan, Gas Machine for Anesthesia or Analgesia, Catalog numbers 8621500 (Atlan A350) and 8621600 (Atlan A350 XL) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Atlan, Gas Machine for Anesthesia or Analgesia, Catalog numbers 8621500 (Atlan A350) and 8621600 (Atlan A350 XL)
Brand
Draegerwerk Ag & Co. Kgaa Dragerwerk Ag & Co. Kgaa Accounts Payable Moislinger Allee
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
Draegerwerk Ag & Co. Kgaa Dragerwerk Ag & Co. Kgaa Accounts Payable Moislinger Allee is recalling Atlan, Gas Machine for Anesthesia or Analgesia, Catalog numbers 8621500 (Atlan A350) and 8621600 (At due to Internal backup battery may fail spontaneously while the Atlan is being operated without AC mains supply, resulting in unexpected shutdown of the devi. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Draeger US was notified of the recall by their corporate office in Germany on November 17, 2023. All 50 units imported into the US at the time had not been distributed to end-users and were under the direct control of Draeger, Inc. Therefore, the firm did not issue a recall communication to customers. As a corrective action, an Instructions for Use (IFU) supplement has been added to these affected devices. The supplement outlines additional instructions regarding battery operation and inspection. Future shipments of Atlan devices will have the IFU supplement included with the device shipment.
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 noticeDistribution
As reported by FDA
IN
Page updated: Jan 10, 2026