Device recall: Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; Product description/Product numbers…
Class I FDA enforcement event 97882. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.
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
Medline Industries, LP started this device recall on 10 Oct 2025. The firm address in the FDA record is in Northfield, IL. FDA put the recall in Class I. FDA event 97882 has 10 product records. The first FDA enforcement report date is 19 Nov 2025. The record gives the status Ongoing. 51 of the 945 device events that started in 2025 have more product records. The median device event of 2025 has 1 product record. The openFDA file has 945 device events that started in 2025 and 972 that started in 2024.
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.
International distribution to Mexico and Panama. US nationwide distribution to the following: AK AL AR AZ CA CO CT FL GA IA IL IN KS KY MA ME MI MN MO MS MT NC NJ NY OH OR PA PR RI SC TN TX WA WI;
Recalling firm
Medline Industries, LP, Northfield, IL.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
10 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0442-2026 | Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; Product description/Product numbers: ADULT 120 EXPANDABLE W/MASK DYNJAA10591; ANES CIRC 120IN EXP-LF DYNJAA6555G; ANES CIRCUIT ADULT 120"-LF DYNJAA10817; ANESTHESIA 120" ADLT-LF DYNJAA10775; ANESTHESIA CIRC ADULT 120-LF DYNJAA10601;… | 96,406 total units | Class I | Ongoing | 19 Nov 2025 |
| Z-0443-2026 | Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; BREATHING KIT-LF DYNJ10550 | 96,406 total units | Class I | Ongoing | 19 Nov 2025 |
| Z-0444-2026 | Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; OPEN HEART SUPPLEMENT DYNJ909116D; VASCULAR DYNJ909124F | 96,406 total units | Class I | Ongoing | 19 Nov 2025 |
| Z-0445-2026 | Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; ENT DYNJ909128I; LARYNGOSCOPY - BRONCHOSCOPY DYNJ909114D | 96,406 total units | Class I | Ongoing | 19 Nov 2025 |
| Z-0446-2026 | DYNJ909119G ROBOTIC GASTRIC LAP SLEEVE-LF DYNJ909127F CYSTO DYNJ909129D GENERAL LAPAROSCOPY-LF | 96,406 total units | Class I | Ongoing | 19 Nov 2025 |
| Z-0447-2026 | Convenience Kit, BREAST HERNIA DYNJ909125G | 96,406 total units | Class I | Ongoing | 19 Nov 2025 |
| Z-0448-2026 | Convenience Kits: DYNJ901048N ORTHO SPINE ST CLAIR DYNJ909123F UROLOGY MINOR DYNJ909132F SET UP DYNJ909308D HIP PINNING | 96,406 total units | Class I | Ongoing | 19 Nov 2025 |
| Z-0449-2026 | Anesthesia circuit kit; CIRCUIT,ANES,EXTENDFLEX,120,LF DYNJAA10230 | 96,406 total units | Class I | Ongoing | 19 Nov 2025 |
| Z-0450-2026 | Convenience kits; DYNJ901046M GYN ROBOTIC DYNJ909120D ROBOTIC PROSTATE | 96,406 total units | Class I | Ongoing | 19 Nov 2025 |
| Z-0451-2026 | Convenience kits; DYNJ901047R ORTHO SPINE FUMICH DYNJ902308K TOTAL JOINT DYNJ909111F DR SALMA'S SPINE DYNJ909117G PATTERSON TOTAL JOINT DYNJ909113F KYPHOPLASTY | 96,406 total units | Class I | Ongoing | 19 Nov 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
- 10Median of the firm: 5
- Events of the firm on the register
- 74
Other events of the firm
Official channels
- FDA enforcement report Z-0442-2026The 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 97882. https://recallregister.com/fda/i/97882/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 3 Nov 2026
- Newest FDA report date on the register
- 28 Oct 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:
International distribution to Mexico and Panama. US nationwide distribution to the following: AK AL AR AZ CA CO CT FL GA IA IL IN KS KY MA ME MI MN MO MS MT NC NJ NY OH OR PA PR RI SC TN TX WA WI;
- What quantity of product is in FDA event 97882?
- The event has 10 product records. The first record gives this quantity:
96,406 total 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.