CLASS I ONGOING Device recall · Reported 20 Nov 2024 · FDA Enforcement Report

Atlan A350XL recalled by Draeger Medical

Draeger Medical is recalling Atlan A350XL, distributed nationwide in the US. The recall was initiated on 15 Oct 2024 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesModel/Catalog Number: 8621600; UDI-DI Number: 04048675556183; Serial Numbers Distributed in the US: ASTA-0307; 0309; 0311; 0349; 0350; 0351; 0353; 0363; 0365; 0394; 0408; 0409 ASTB-0048; 0286; 0287; 0288; 0289; 0290; 0291; 0304; 0305; 0306; 0307; 0308; 0309; 0317; 0318; 0319; 0320; 0321; 0322 ASTC-0006; 0007; 0068; 0069; 0070; 0082; 0083; 0099; 0100; 0101; 0105; 0106; 0107; 0108; 0109; 0118; 0119; 0136; 0137; 0229; 0230; 0243; 0244; 0245 ASTD-0008; 0009; 0010; 0011; 0012; 0013; 0014; 0129; 0130; 0131; 0132; 0133; 0134; 0135; 0154; 0159; 0160; 0161; 0162; 0163; 0164; 0165; 0166; 0167; 0168; 0169; 0181; 0182; 0183; 0193; 0194; 0195; 0225; 0226; 0227; 0228; 0229; 0230; 0231; 0238; 0239; 0240; 0241; 0242; 0243; 0244; 0245 ASTE-0016; 0017; 0077; 0078; 0079; 0086; 0087; 0122; 0123; 0124; 0125; 0126; 0129; 0130; 0131; 0163; 0164; 0165; 0166; 0171; 0172; 0173; 0174; 0195; 0196; 0197; 0198; 0203; 0225; 0226; 0246; 0247; 0248; 0249; 0250; 0278; 0279; 0280; 0281; 0301; 0302; 0303; 0304; 0305; 0306; 0348; 0349; 0350; 0351; 0352; 0357; 0358; 0359; 0360; 0361; 0362 ASTF-0001; 0002; 0003; 0004; 0014; 0015; 0016; 0017; 0018; 0030; 0031; 0032; 0033; 0034; 0035; 0036; 0037; 0055; 0061; 0062; 0063; 0070; 0071; 0076; 0077; 0078; 0079; 0080; 0081; 0121; 0122; 0123; 0124; 0125; 0135; 0136; 0137; 0138; 0139; 0140; 0141; 0168; 0169; 0170; 0194; 0195; 0196; 0409; 0410; 0411; 0436; 0437; 0438; 0474; 0475; 0476; 0477; 0478 ASTH-0007; 0008; 0009; 0010; 0011; 0012; 0092; 0093; 0094; 0095; 0096; 0120; 0121; 0122; 0123; 0124; 0125; 0126; 0142; 0143; 0144; 0145; 0146; 0147; 0148; 0169; 0170; 0171; 0172; 0173; 0174; 0175; 0187; 0188; 0189; 0190; 0191; 0192; 0269; 0270; 0271; 0272; 0273; 0293; 0294; 0295; 0296; 0306; 0307; 0308; 0309; 0310; 0311; 0324; 0325; 0326; 0327; 0330; 0331; 0332; 0333; 0334; 0335; 0336; 0337; 0338; 0339; 0358; 0359; 0360; 0361; 0362; 0363; 0364; 0365; 0383; 0384; 0385; 0386; 0387; 0388; 0389; 0390; 0450; 0476; 0477; 0478; 0479; 0480; 0481; 0488; 0489; 0490; 0491 Serial Numbers Distributed OUS: ASTA-0253; 0289; 0290; 0327; 0362; 0404; 0405; 0426; 0427; 0428; 0429; 0430 ASTB-0003; 0005; 0007; 0028; 0029; 0030; 0031; 0032; 0033; 0075; 0076; 0077; 0079; 0080; 0081; 0082; 0083; 0084; 0134; 0195; 0206; 0219; 0220; 0237 ASTC-0001; 0002; 0003; 0004; 0026; 0138; 0163; 0180; 0181; 0194; ASTD-0015; 0016; 0050; 0061; 0062; 0063; 0064; 0065; 0066; 0203; 0204; 0205; 0265; 0266; 0267 ASTE-0034; 0035; 0057; 0058; 0059; 0060; 0062; 0085; 0108; 0127; 0128; 0175; 0202; 0223; 0224; 0300; 0325; 0326; 0327; 0328; 0329; 0353; 0354; 0355; 0356 ASTF-0051; 0052; 0053; 0054; 0112; 0113; 0435; 0471 ASTH-0039; 0040; 0045; 0046; 0081; 0082; 0176; 0193; 0194; 0204; 0217; 0218; 0219; 0225; 0226; 0243; 0244; 0245; 0246; 0255; 0256; 0382; 0403; 0404; 0405; 0406; 0434; 0435; 0436; 0437; 0451; 0452; 0453; 0 ASTJ-0063; 0064; 0065; 0066; 0067; 0068; 0089; 0090; 0091; 0092; 0145; 0146; 0147; 0171; 0237 ASTK-0002

Quantity recalled455 units (310 units US, 145 OUS)

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-0305-2025
FDA event ID: 95561
Recalling firm: Draeger Medical, Telford, PA
Classification: Class I
Status: Ongoing
Recall initiated: 15 Oct 2024
FDA classified: 13 Nov 2024
Reported: 20 Nov 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Medical Software

Timeline

15 Oct 2024	Recall initiated by company
13 Nov 2024	Classified by FDA	+29 days
20 Nov 2024	Published in enforcement report	+7 days

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

Reason for recall

The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Component: Not applicable

Where it was distributed

US Nationwide distribution in the states of AL, AZ, CA, FL, GA, IA, IL, KY, MA, ME, ND, NE, NH, NJ, NY, OH, PA, TN, TX, WI, WY. International distribution: Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Brazil, Bulgaria, Cambodia, Canada, Chili, China, Columbia, Croatia, Czech Republic, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Hungary, India, Indonesia, Ireland, Italy, Japan, Jordan, Kazakhstan, Kenya, Latvia, Malaysia, Mauritius, Mexico, Morocco, Namibia, Nepal, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, Uruguay, United Arab Emirates, Vietnam.

Nationwide Alabama Arizona California Florida Georgia Iowa Illinois Kentucky Massachusetts Maine North Dakota Nebraska New Hampshire New Jersey New York Ohio Pennsylvania Tennessee Texas Wisconsin

Questions about this recall

Why was it recalled?

The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.

Which lots are affected?

Model/Catalog Number: 8621600; UDI-DI Number: 04048675556183; Serial Numbers Distributed in the US: ASTA-0307; 0309; 0311; 0349; 0350; 0351; 0353; 0363; 0365; 0394; 0408; 0409 ASTB-0048; 0286; 0287; 0288; 0289; 0290; 0291; 0304; 0305; 0306; 0307; 0308; 0309; 0317; 0318; 0319; 0320; 0321; 0322 ASTC-0006; 0007; 0068; 0069; 0070; 0082; 0083; 0099; 0100; 0101; 0105; 0106; 0107; 0108; 0109; 0118; 0119; 0136; 0137; 0229; 0230; 0243; 0244; 0245 ASTD-0008; 0009; 0010; 0011; 0012; 0013; 0014; 0129; 0130; 0131; 0132; 0133; 0134; 0135; 0154; 0159; 0160; 0161; 0162; 0163; 0164; 0165; 0166; 0167; 0168; 0169; 0181; 0182; 0183; 0193; 0194; 0195; 0225; 0226; 0227; 0228; 0229; 0230; 0231; 0238; 0239; 0240; 0241; 0242; 0243; 0244; 0245 ASTE-0016; 0017; 0077; 0078; 0079; 0086; 0087; 0122; 0123; 0124; 0125; 0126; 0129; 0130; 0131; 0163; 0164; 0165; 0166; 0171; 0172; 0173; 0174; 0195; 0196; 0197; 0198; 0203; 0225; 0226; 0246; 0247; 0248; 0249; 0250; 0278; 0279; 0280; 0281; 0301; 0302; 0303; 0304; 0305; 0306; 0348; 0349; 0350; 0351; 0352; 0357; 0358; 0359; 0360; 0361; 0362 ASTF-0001; 0002; 0003; 0004; 0014; 0015; 0016; 0017; 0018; 0030; 0031; 0032; 0033; 0034; 0035; 0036; 0037; 0055; 0061; 0062; 0063; 0070; 0071; 0076; 0077; 0078; 0079; 0080; 0081; 0121; 0122; 0123; 0124; 0125; 0135; 0136; 0137; 0138; 0139; 0140; 0141; 0168; 0169; 0170; 0194; 0195; 0196; 0409; 0410; 0411; 0436; 0437; 0438; 0474; 0475; 0476; 0477; 0478 ASTH-0007; 0008; 0009; 0010; 0011; 0012; 0092; 0093; 0094; 0095; 0096; 0120; 0121; 0122; 0123; 0124; 0125; 0126; 0142; 0143; 0144; 0145; 0146; 0147; 0148; 0169; 0170; 0171; 0172; 0173; 0174; 0175; 0187; 0188; 0189; 0190; 0191; 0192; 0269; 0270; 0271; 0272; 0273; 0293; 0294; 0295; 0296; 0306; 0307; 0308; 0309; 0310; 0311; 0324; 0325; 0326; 0327; 0330; 0331; 0332; 0333; 0334; 0335; 0336; 0337; 0338; 0339; 0358; 0359; 0360; 0361; 0362; 0363; 0364; 0365; 0383; 0384; 0385; 0386; 0387; 0388; 0389; 0390; 0450; 0476; 0477; 0478; 0479; 0480; 0481; 0488; 0489; 0490; 0491 Serial Numbers Distributed OUS: ASTA-0253; 0289; 0290; 0327; 0362; 0404; 0405; 0426; 0427; 0428; 0429; 0430 ASTB-0003; 0005; 0007; 0028; 0029; 0030; 0031; 0032; 0033; 0075; 0076; 0077; 0079; 0080; 0081; 0082; 0083; 0084; 0134; 0195; 0206; 0219; 0220; 0237 ASTC-0001; 0002; 0003; 0004; 0026; 0138; 0163; 0180; 0181; 0194; ASTD-0015; 0016; 0050; 0061; 0062; 0063; 0064; 0065; 0066; 0203; 0204; 0205; 0265; 0266; 0267 ASTE-0034; 0035; 0057; 0058; 0059; 0060; 0062; 0085; 0108; 0127; 0128; 0175; 0202; 0223; 0224; 0300; 0325; 0326; 0327; 0328; 0329; 0353; 0354; 0355; 0356 ASTF-0051; 0052; 0053; 0054; 0112; 0113; 0435; 0471 ASTH-0039; 0040; 0045; 0046; 0081; 0082; 0176; 0193; 0194; 0204; 0217; 0218; 0219; 0225; 0226; 0243; 0244; 0245; 0246; 0255; 0256; 0382; 0403; 0404; 0405; 0406; 0434; 0435; 0436; 0437; 0451; 0452; 0453; 0 ASTJ-0063; 0064; 0065; 0066; 0067; 0068; 0089; 0090; 0091; 0092; 0145; 0146; 0147; 0171; 0237 ASTK-0002

Where was it sold?

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 I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

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.

Other products in this recall event

1 other product · FDA event 95561

Reported	Class	Recall	Company	Reason	Where
20 Nov 2024	CLASS I	Atlan A350 recalled by Draeger Medical	Draeger Medical	Device Malfunction	Nationwide

More recalls from Draeger Medical

All 78

Reported	Class	Recall	Company	Reason	Where
25 Dec 2024Device	CLASS I	Atlan A300 recalled by Draeger Medical	Draeger Medical	Device Malfunction	PA
25 Dec 2024Device	CLASS I	Atlan A300XL recalled by Draeger Medical	Draeger Medical	Device Malfunction	PA
20 Nov 2024Device	CLASS I	Atlan A350 recalled by Draeger Medical	Draeger Medical	Device Malfunction	Nationwide
24 Apr 2024Device	CLASS I	Dr¿ger Perseus A500 Anesthesia Workstation recalled by Draeger Medical	Draeger Medical	Device Malfunction	Nationwide
30 Aug 2023Device	CLASS I	Carina Sub-Acute Care Ventilator recalled by Draeger Medical	Draeger Medical	Other	Nationwide

Other Medical Software recalls

All 930

Reported	Class	Recall	Company	Reason	Where
7 Oct 2026Device	CLASS II	SmartPath to dStream for XR and 3.0T recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Upgrade to MR recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Positron Emission Tomography and Computed Tomography System recalled	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Tandem t:slim mobile application t:slim Mobile Application, iOS recalled	Tandem Diabetes Care	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Ingenia Elition S and Ingenia Elition recalled by Philips North America	Philips North America	Device Malfunction	Nationwide