Medline Convenience Kits: 1) OPEN HEART CDS — Class I medical device recall Z-2453-2026
Ongoing recall by Medline Industries, LP, reported 2026-07-01, distributed nationwide. The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP a
| Recall number | Z-2453-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries, LP, Northfield, IL, United States |
| Recall initiated | 2026-05-06 |
| Classified | 2026-06-24 |
| Reported by FDA | 2026-07-01 |
| Distributed | Nationwide (US) |
| Quantity | 6,775 units |
| UPC / GTIN / UDI-DI | 10193489263121, 10193489462821, 10195327263102, 10195327297077, 10195327352998, 10195327355692, 10195327439064, 10195327461294, 10195327511142, 10195327537883, 10195327569518, 10195327574932, 10195327648046, 10195327650148, 10195327658328, 10195327678395, 10195327694579, 10198459022531, 10198459024863, 10198459047947, 10198459055355, 10198459079733, 10198459096228, 10198459112386, 10198459118548 and 83 more |
| Lot numbers | 100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 116, 117, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, 130, 131, 132, 133, 134, 135, 136, 137, 138, 139 and 427 more |
| Model numbers | CDS840144Q, CDS840150W, CDS840396AA, CDS982269N, CDS983849G, CDS984289L, CDS985105Q, DYNJ901075R, DYNJ902664L, DYNJ903465I, DYNJ903822F, DYNJ904311F, DYNJ904749J, DYNJ905567B, DYNJ906102K, DYNJ906225I, DYNJ907400F, DYNJ908121C, DYNJ908308A, DYNJ909116D, DYNJ9622573AP, DYNJ9718008AT |
Product
Medline Convenience Kits: 1) OPEN HEART CDS, Model Number: CDS840144Q; 2) OPEN HEART, Model Number: CDS840150W; 3) OPEN HEART ADULT, Model Number: CDS840396AA; 4) CABG A CDS, Model Number: CDS982269N; 5) OPEN HEART ANESTHESIA PACK, Model Number: CDS983849G; 6) OPEN HEART ACCESSORY CDS, Model Number: CDS984289L; 7) OPEN HEART A, Model Number: CDS985105Q; 8) OPEN HEART PART 2, Model Number: DYNJ901075R; 9) VPH OPEN HEART, Model Number: DYNJ902664L; 10) HEART A, Model Number: DYNJ903465I; 11) HEART, Model Number: DYNJ903822F; 12) OPEN HEART BASIC B, Model Number: DYNJ904311F; 13) SM OPEN HEART PACK A&B, Model Number: DYNJ904749J; 14) OPEN HEART ANESTHESIA ICC-B, Model Number: DYNJ905567B; 15) SILVER CROSS OPEN HEART, Model Number: DYNJ906102K; 16) ANESTHESIA OPEN HEART, Model Number: DYNJ906225I; 17) OPEN HEART COMBO, Model Number: DYNJ907400F; 18) CARDIAC CABG B, Model Number: DYNJ908121C; 19) FS OPEN HEART, Model Number: DYNJ908308A; 20) OPEN HEART SUPPLEMENT, Model Number: DYNJ909116D; 21) MEM CARDIAC, Model Number: DYNJ9622573AP; 22) OPEN HEART A & B PACK, Model Number: DYNJ9718008AT
Reason for recall
The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA inspection of the supplier.
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-2453-2026. 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.