# FDA recall Z-2453-2026

> **Medline Industries, LP** · Class I · device recall initiated 2026-05-06.

## 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.

## Distribution

US Nationwide.

## Key facts

- **Recall number:** Z-2453-2026
- **Recalling firm:** Medline Industries, LP
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-05-06
- **Report date:** 2026-07-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Northfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2453-2026

## Citation

> MORVS. FDA recall Z-2453-2026. Retrieved 2026-10-19 from https://api.morvs.ai/recall/Z-2453-2026. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*