Device recall: Brand Name: VentStar Product Name: VentStar Flex 220 Model/Catalog Number: MP00355 Software Version: Not applicable…
Class I FDA enforcement event 96342. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
The potential for cracks forming in the breathing circuit hose.
Class I, in the words of FDA
a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death
Draeger, Inc. started this device recall on 12 Mar 2025. The firm address in the FDA record is in Telford, PA. FDA put the recall in Class I. FDA event 96342 has 7 product records. The first FDA enforcement report date is 9 Apr 2025. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Domestic: Nationwide Distribution. International - following countries: Austria, Belgium, Bulgaria, China, Croatia, Czech Republic, France, Germany, Ghana, Greece, Guatemala, Hungary, India, Italy,…
Recalling firm
Draeger, Inc., Telford, PA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
7 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1493-2025 | Brand Name: VentStar Product Name: VentStar Flex 220 Model/Catalog Number: MP00355 Software Version: Not applicable Product Description: Breathing circuit for conveying breathing gases between an anesthesia machine or ventilator and adult patients. The breathing circuit is intended for single use only. Component: Not… | 65150 units | Class I | Ongoing | 9 Apr 2025 |
| Z-1494-2025 | Brand Name: ID Circuit Product Name: ID Circuit Flex 220 Model/Catalog Number: MP01347 Software Version: Not applicable Product Description: Breathing circuit for conveying breathing gases between an anesthesia machine or ventilator and adult Component: Not applicable | 3325 units | Class I | Ongoing | 9 Apr 2025 |
| Z-1495-2025 | Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 1 Model/Catalog Number: MP02737 Software Version: Not applicable Product Description: Accessory for conducting medical gases between anesthesia machine and patient for anesthetic use. Kit is intended for single use only Component: Not… | 3140 | Class I | Ongoing | 9 Apr 2025 |
| Z-1496-2025 | Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 2 Model/Catalog Number: MP02738 Software Version: Not applicable Product Description: Accessory for conducting medical gases between anesthesia machine and patient for anesthetic use. Kit is intended for single use only Component: Not… | 780 units | Class I | Ongoing | 9 Apr 2025 |
| Z-1497-2025 | Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 6 Model/Catalog Number: MP02744 Software Version: Not applicable Product Description: Accessory for conducting medical gases between anesthesia machine and patient for anesthetic use. Kit is intended for single use only | 293660 units | Class I | Ongoing | 9 Apr 2025 |
| Z-1498-2025 | Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex (P)2 Model/Catalog Number: MP02752 Software Version: Not applicable Product Description: Accessory for conducting medical gases between anesthesia machine and patient for anesthetic use. Kit is intended for single use only Component: Not… | 9250 units | Class I | Ongoing | 9 Apr 2025 |
| Z-1499-2025 | Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex EPA Model/Catalog Number: MP17103 Software Version: Not applicable Product Description: Accessory for conducting medical gases between anesthesia machine and patient for anesthetic use. Kit is intended for single use only | 13620 units | Class I | Ongoing | 9 Apr 2025 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class I: The highest of the three FDA recall classes.
The event in context
- Device events that started in 2025
- 945
- Share of these events in Class I
- 13%
- Product records in this event
- 7Median of the firm: 4
- Events of the firm on the register
- 6
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 7 May 2026 | Atlan A350. Model Number: 8211500. anesthesia workstation | Device | Class I | 2 |
| 24 Nov 2025 | Draeger Vapor 2000. Unheated, calibrated anesthetic vaporizer. | Device | Class I | 2 |
| 10 Nov 2025 | ErgoStar CM 40 Model/Catalog Number: MP01840 Airway connector for conduction of respiratory gases between the breathing | Device | Class I | 4 |
| 9 Sep 2025 | Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Product Descri | Device | Class I | 2 |
| 16 Jun 2025 | SafeStar 90 Plus Filter. Bidirectionally breathing system filter. | Device | Class I | 4 |
Official channels
- FDA enforcement report Z-1493-2025The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 96342. https://recallregister.com/fda/i/96342/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Domestic: Nationwide Distribution. International - following countries: Austria, Belgium, Bulgaria, China, Croatia, Czech Republic, France, Germany, Ghana, Greece, Guatemala, Hungary, India, Italy,…
- What quantity of product is in FDA event 96342?
- The event has 7 product records. The first record gives this quantity:
65150 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2025 have the same class?
- 13% of the 945 device events that started in 2025 are in Class I.