Sterile Procedural Trays — Class II medical device recall Z-1078-2023
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2023-02-15, distributed nationwide. Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the st
| Recall number | Z-1078-2023 |
|---|---|
| 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 | 2022-11-17 |
| Classified | 2023-02-06 |
| Reported by FDA | 2023-02-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, CA, JP, MX, PA |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10195327109134, 10195327110819, 10195327110826, 10195327112332, 10195327116774, 10195327130268, 10195327140144, 10195327143510, 10195327144197, 10195327146979, 10195327154301, 10195327164508, 10195327189549, 10195327201999, 10195327218324, 10195327221454, 10195327230609, 10195327244439, 10195327246310, 10195327252021, 10195327253295, 40195327109135, 40195327110810, 40195327110827, 40195327112333 and 17 more |
| Lot numbers | 22GBW998, 22HBT951, 22HBU014, 22HBV171, 22HBW917, 22HBY465, 22HLA208, 22HMD087, 22HMD203, 22IBC646, 22IBH244, 22IBK206, 22IBS662, 22IBV340, 22IDA519, 22ILA590, 22ILA886, 22IMF862, 22JBA257, 22JBD534, 22JBE052, 22JBH137, 22JBH675, 22JBH710, 22JBN923, 22JBU478, 22JBV631, 22JBW819, 22JBX225, 22JLA323, 22JLA612, 22JMA882, 22JMB641, 22JMB780, 22JMC641, 22JMH995 |
| Model numbers | DYNJ24628M, DYNJ35592K, DYNJ35596G, DYNJ41354B, DYNJ47991J, DYNJ48354I, DYNJ50123D, DYNJ50906F, DYNJ52541D, DYNJ57608B, DYNJ58389D, DYNJ62766B, DYNJ63961B, DYNJ66012A, DYNJ69406A, DYNJ81646, DYNJ82390, DYNJ82969, DYNJ907808B, GSP158AA, GSP158AB |
Product
Sterile Procedural Trays, labeled as the following: a. ST. ANNE'S MAJOR BASIN SET UP b. SINGLE BASIN SET c. DOUBLE BASIN SET d. LAPAROTOMY BASIN e. ORTHOPEDIC CUSTOM BASIN SET f. OISC BASIN TRAY g. BASIN PACK h. BASIN SET i. SURGI START PACK j. PK, GEN-SET UP - MIDWEST k. SINGLE BASIN PACK-LF l. AGHM MINOR SINGLE PACK m. MINOR PACK n. SINGLE BASIN PACK o. MAJOR BASIN PACK p. BASIC SET UP-LF q. BASIC SET-UP-LF r. BASIN PACK s. MINOR BASIN t. AMC MAJOR BASIN u. AMC MAJOR BASIN
Reason for recall
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
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-1078-2023. 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.