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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device

Draeger Medical, Inc.: Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.

Agency Publication Date: May 17, 2023
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Affected Products

Product: Seattle PAP Plus, MP02260

UDI-DI: 04048675548904; All lots distributed prior to 03/20/2023 (lots other than 0367.2702.13).

Product: VentStar Basic (P)180, MP00351

UDI-DI: 04048675422068; All lots.

Product: VentStar Basic (P)250, MP00352

UDI-DI: 04048675422051; All lots.

Product: VentStar Watertrap (P) 180, MP00361

UDI-DI: 04048675422013; All lots.

Product: VentStar Watertrap (P) 180 w/oLL, MP00362

UDI-DI: 04048675422006; All lots.

Product: VentStar Anesthesia WT (P)180, MP00374

UDI-DI: 04048675421948; All lots.

Product: VentStar breathing bag Set (P) 110, MP00384

UDI-DI: 04048675421870; All lots.

Product: ID Circuit Basic (P) 180, MP01340

UDI-DI: 04048675421870; All lots.

Product: VentStar Anesthesia (N) 180, MP00333

UDI-DI: 04048675422198; All lots.

Product: VentStar Basic (N) 180, MP00353

UDI-DI: 40048675422044; All lots.

Product: VentStar Watertrap (N) 180, MP00363

UDI-DI: 04048675421993; All lots.

Product: VentStar Bag Set (N) 110, MP00383

UDI-DI: 04048675421887; All lots.

Product: VentStar Coax (P) 150, MP00379

UDI-DI: 04048675421917; All lots.

Product: Anesthesia Circuit Kit Coax 1, MP02730

UDI-DI: 04048675412014; All lots.

Product: Anesthesia Circuit Kit Coax 3, MP02732

UDI-DI: 04048675412038; All lots.

Product: Ventstar Coax, MP03373

UDI-DI: 04048675545552; All lots.

Product: Ventstar Coax 180, MP03374

UDI-DI: 04048675545576; All lots.

Product: ID Coax 180, MP03375

UDI-DI: 04048675545590; All lots.

Product: Ventstar Coax 230, MP03376

UDI-DI: 04048675545613; All lots.

Product: Anesthesia Set Coax 180, MP03384

UDI-DI: 04048675552833; All lots.

Product: Set2Go Ventilation 12 (A), MP07968

UDI-DI: 04048675544739; All lots.

Product: Anesthesia Circuit Kit Coax HEPA, MP17102

UDI-DI: 04048675695622; All lots.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92049
Status: Resolved
Manufacturer: Draeger Medical, Inc.
Manufactured In: United States
Units Affected: 21 products (32,050 untis; 325 units; 200 units; 50 units; 25 units; 130 units; 25 units; 25 units; 1,725 units; 125 units; 375 units; 280 units; 200,900 units; 329,294 units; 2,380 units; 18,160 units; 20 units; 40 units; 20 units; 500 units; 720 units)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.