Medline Industries, LP medical device recall: Medline Convenience Kits: 1) DYNJ905503F
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 99043
- Recall initiated
- May 6, 2026
- Classified by FDA
- Jun 24, 2026
- Posted in Enforcement Report
- Jul 1, 2026
- Recalling firm
- Medline Industries, LP
- Firm location
- Northfield, IL, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Letter
- Products in this event
- 4
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
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.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on May 6, 2026. FDA classified it 49 days later, on Jun 24, 2026. This recall event covers 4 separate products, each with its own FDA recall number. Distribution reported by FDA: US Nationwide. Medline Industries, LP has 257 recalls in our records.
Recalled products (4)
Z-2452-2026 Class I Ongoing
Medline Convenience Kits: 1) DYNJ905503F, Model Number: CV ANESTHESIA - ROOM SET UP; 2) DYNJ905503G, Model Number: CV ANESTHESIA - ROOM SET UP
Codes / lots: 1) DYNJ905503F, UDI-DI: 10193489967272(each), 40193489967273(case), Lot Number: 24GBR740; 2) DYNJ905503F, UDI-DI: 10193489967272(each), 40193489967273(case), Lot Number: 24JBP984; 3) DYNJ905503G, UDI-DI: 10198459200397(each), 40198459200398(case), Lot Number: 26DBJ110; 4) DYNJ905503G, UDI-DI: 10198459200397(each), 40198459200398(case), Lot Number: 25ABJ069; 5) DYNJ905503G, UDI-DI: 10198459200397(each), 40198459200398(case), Lot Number: 25ABL749; 6) DYNJ905503G, UDI-DI: 10198459200397(each), 40198459200398(case), Lot Number: 25CBB762; 7) DYNJ905503G, UDI-DI: 10198459200397(each), 40198459200398(case), Lot Number: 25DBG799; 8) DYNJ905503G, UDI-DI: 10198459200397(each), 40198459200398(case), Lot Number: 25EBM994; 9) DYNJ905503G, UDI-DI: 10198459200397(each), 40198459200398(case), Lot Number: 25GBW226; 10) DYNJ905503G, UDI-DI: 10198459200397(each), 40198459200398(case), Lot Number:…
Quantity: 227 units
Z-2453-2026 Class I Ongoing
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
Codes / lots: 1) CDS840144Q, UDI-DI: 10195327263102(each), 40195327263103(case), Lot Number: 24LBH805; 2) CDS840144Q, UDI-DI: 10195327263102(each), 40195327263103(case), Lot Number: 24HBM100; 3) CDS840144Q, UDI-DI: 10195327263102(each), 40195327263103(case), Lot Number: 25ABR195; 4) CDS840144Q, UDI-DI: 10195327263102(each), 40195327263103(case), Lot Number: 25EBS810; 5) CDS840144Q, UDI-DI: 10195327263102(each), 40195327263103(case), Lot Number: 25FBS936; 6) CDS840144Q, UDI-DI: 10195327263102(each), 40195327263103(case), Lot Number: 25GBX096; 7) CDS840144Q, UDI-DI: 10195327263102(each), 40195327263103(case), Lot Number: 25IBT859; 8) CDS840144Q, UDI-DI: 10195327263102(each), 40195327263103(case), Lot Number: 24KBE879; 9) CDS840144R, UDI-DI: 10198459561627(each), 40198459561628(case), Lot Number: 26DBF234; 10) CDS840144R, UDI-DI: 10198459561627(each), 40198459561628(case), Lot Number: 26ABG176; 11)…
Quantity: 6775 units
Z-2454-2026 Class I Ongoing
Medline Convenience Kits: 1) DRAWER 6 CENTRAL LINE INSERTIO, Model Number: ACC011142; 2) CENTRAL AND ARTERIAL LINE TOTE, Model Number: DYNJ8407
Codes / lots: 1) ACC011142, UDI-DI: 10198459721342(each), 40198459721343(case), Lot Number: 26DDA462; 2) ACC011142, UDI-DI: 10198459721342(each), 40198459721343(case), Lot Number: 26DDA547; 3) DYNJ8407, UDI-DI: 10198459704543(each), 40198459704544(case), Lot Number: 26DBB599
Quantity: 233 units
Z-2455-2026 Class I Ongoing
Medline Convenience Kits: 1) DRAWER 6A ADULT CENTRAL LINE, Model Number: ACC010890; 2) OPEN HEART A OVERHEAD, Model Number: DYNJ910066; 3) OPEN HEART, Model Number: DYNJ9855016V; 4) OPEN HEART, Model Number: DYNJ9855016X
Codes / lots: 1) ACC010890, UDI-DI: 10198459139833(each), 40198459139834(case), Lot Number: 25BDA811; 2) ACC010890, UDI-DI: 10198459139833(each), 40198459139834(case), Lot Number: 25DDB415; 3) ACC010890, UDI-DI: 10198459139833(each), 40198459139834(case), Lot Number: 25DDC095; 4) DYNJ910066, UDI-DI: 10195327565596(each), 40195327565597(case), Lot Number: 25ADB324; 5) DYNJ910066, UDI-DI: 10195327565596(each), 40195327565597(case), Lot Number: 25FDB473; 6) DYNJ910066, UDI-DI: 10195327565596(each), 40195327565597(case), Lot Number: 25GDA336; 7) DYNJ910066, UDI-DI: 10195327565596(each), 40195327565597(case), Lot Number: 24FDB427; 8) DYNJ9855016V, UDI-DI: 10198459019951(each), 40198459019952(case), Lot Number: 25ABH622; 9) DYNJ9855016V, UDI-DI: 10198459019951(each), 40198459019952(case), Lot Number: 25CBA788; 10) DYNJ9855016V, UDI-DI: 10198459019951(each), 40198459019952(case), Lot Number: 25CBF665; 11)…
Quantity: 503 units
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 99043
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.