Non-sterile convenience kits: a — Class II medical device recall Z-2230-2024
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2024-07-10, distributed nationwide. Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in
| Recall number | Z-2230-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2024-03-14 |
| Classified | 2024-06-28 |
| Reported by FDA | 2024-07-10 |
| Distributed | Nationwide (US) |
| Quantity | 7,673 non |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 40195327085606 |
| Lot numbers | 23CBT397, 23DDB062, 23FBI255, 23GBF800, 23GBG661, 23GBJ039, 23HDA517, 23IBN598, 23IDA976, 23IDA980, 23JBT059, 23LBD262, 24ABY293, 24ADA089 |
| Expiration dates | 2024-04-30, 2024-07-31, 2024-08-31, 2024-09-30, 2024-10-31, 2024-11-30, 2024-12-31, 2025-02-28, 2025-04-30, 2026-03-31 |
Product
Non-sterile convenience kits: a. Medline Difficult Airway Tray W/O Cook, Pack #ACC010578, containing a Pure Pouch with component Reorder #DYNJ040408, Kelly Forceps/STD STR Sterile. b. Medline Adult/Child Intubation Kit, Pack #ACC010616 and Pack #ACC010616H, containing a Pure Pouch with component Reorder #66790, Sterile Magill Forceps. c. Medline Intubation Tray (Adult), Pack #DYNJAA245A, containing a Pure Pouch with component Reorder #66790, Sterile Magill Forceps. d. Medline Adult Main Disp. Intub Part A, Pack #DYNJAA262A, containing a Pure Pouch with component Reorder #66790, Sterile Magill Forceps. e. Medline Adult Anesthesia Tray, Pack #DYNJAA276, containing a Pure Pouch with component Reorder #66790, Sterile Magill Forceps. f. Medline Baby Care Kit, Pack #DYKL1025 and Pack #DYKL1025H, containing a Pure Pouch with component Reorder #DYND04000, O.R. Scissors, S/B, 5.5 Sterile.
Reason for recall
Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2230-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.