Medline Kits: 1) BWNBORO CRANIOTOMY PACK-LF — Class II medical device recall Z-1849-2026
Ongoing recall by Medline Industries, LP, reported 2026-04-29, distributed nationwide. The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have be
| Recall number | Z-1849-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries, LP, Northfield, IL, United States |
| Recall initiated | 2026-02-25 |
| Classified | 2026-04-17 |
| Reported by FDA | 2026-04-29 |
| Distributed | Nationwide (US) |
| Quantity | 2,609 units |
| UPC / GTIN / UDI-DI | 10193489493184, 10193489870411, 10195327037796, 10195327273705, 10195327349882, 10198459220227, 10889942735549, 40193489493185, 40193489870412, 40195327037797, 40195327273706, 40195327349883, 40198459220228, 40889942735540 |
| Lot numbers | 22KBJ690, 23BBD696, 23DBG588, 23FBD221, 23GBN050, 23IBB710, 23JBS196, 23LBM277, 24BMC999, 24BME364, 24CBF407, 24CBN011, 24DBK248, 24GBC694, 24HBX136, 24IBR538, 24KBE401, 24KBG704, 25ABC728, 25BBO542, 25BBT096, 25CBE147, 25CBP816, 25DBO043, 25EBM284 |
| Model numbers | DYNJ32841F, DYNJ46069D, DYNJ51935A, DYNJ68902A, DYNJ80679A, DYNJ82370A, DYNJ84272 |
Product
Medline Kits: 1) BWNBORO CRANIOTOMY PACK-LF, Model Number: DYNJ32841F; 2) CRANIOTOMY PACK-LF, Model Number: DYNJ46069D 3) CAMPUS EXTREMITY PK, Model Number: DYNJ51935A 4) FOOT -XRAY BOWL MEDCUP SPECCUP, Model Number: DYNJ68902A 5) RADIOLOGY SPINE PACK, Model Number: DYNJ80679A 6) DR CHA CUSTOM PACK, Model Number: DYNJ82370A 7) SPINE PACK HC, Model Number: DYNJ84272
Reason for recall
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
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-1849-2026. 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.