Recall Register

Food, drugs, devices › Medline Industries, LP

Device recall: Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: AN01 CAROTID ANESTH KI

FDA enforcement event 98154 · Class II · initiated 26 Nov 2025 · status Ongoing

DeviceVoluntary: Firm initiated12 product recordsNorthfield, IL

Medline Industries, LP (Northfield, IL) initiated this device recall on 26 Nov 2025; FDA lists 12 product records under event 98154, classified Class II.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 85% of the 945 device enforcement events initiated in 2025 carry the same class.

Status: Ongoing. Initiation: voluntary: firm initiated. Medline Industries, LP has 66 enforcement events on this register, with a median of 5 product records per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Medline Industries, LP, Northfield, IL.

Reason for recall

"Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions."

Distribution

"US Nationwide distribution."

Product records

Recall numberProductQuantityClassStatusReport date
Z-1049-2026Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: AN01 CAROTID ANESTH KIT-LF, Medline Kit SKU PHS972096014B10 unitsClass IIOngoing21 Jan 2026
Z-1050-2026Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) OPEN HEART ACCESSORY CDSKit SKU CDS984289O; 2) OPEN HEART CDSKit SKU CDS984355K; 3) BAG A OPEN HEART KITKit SKU DYKM1025D; 4) RR-CABG SUPPLEMENTAL PACKKit SKU DYNJ0394752O; 5) OPEN HEART CDSKit SKU DYNJ902879T; 6)…633 unitsClass IIOngoing21 Jan 2026
Z-1051-2026Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) DELUXE PRE OP KIT, Medline SKU DYKS2034A; 2) DELUXE PRE OP KIT, Medline SKU DYKS2006B.32 unitsClass IIOngoing21 Jan 2026
Z-1052-2026Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) RR-LE FORT MANDIBLE PACK-LF, Medline Kit SKU DYNJ0785864R; 2) RR-ASC EAR PACK-LF, Medline Kit SKU DYNJ0792607R.96 unitsClass IIOngoing21 Jan 2026
Z-1053-2026Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: RR-LAP DONOR NEP ACCESSORY, Medline kit SKU DYNJ63395B33 unitsClass IIOngoing21 Jan 2026
Z-1054-2026Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: DR HOLCOMB FACIAL PACK, Medline kit SKU DYNJ54488A16 unitsClass IIOngoing21 Jan 2026
Z-1055-2026Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) DRAWER 2 IV SUPPLIES, Medline kit SKU ACC010271B; 2) DRAWER 2 IV FLUIDS & TUBING, Medline kit SKU ACC010416B; 3) OXYGENATION & TUBING TRAY, Medline kit SKU ACC010525C; 4) TOP DRAWER #6, Medline kit SKU ACC010688; 5)…3045 unitsClass IIOngoing21 Jan 2026
Z-1056-2026Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) IV START KIT NS, Medline kit SKU DYKM1980C; 2) (134) L&D IV-START SET, Medline kit SKU DYKM2137B; 3) IV START KIT, Medline kit SKU DYKS1372C; 4) IV START KIT, Medline kit SKU DYNDV1691B; 5) OUTPATIENT 2 TO 5 YEARS,…5314 unitsClass IIOngoing21 Jan 2026
Z-1057-2026Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) PRE OP KIT, Medline kit SKU DYKS1093B; 2) PRE OP KIT, Medline kit SKU DYKS1124C; 3) PRE OP KIT, Medline kit SKU DYKS1128C; 4) PREOP KIT, Medline kit SKU DYKS1130B; 5) PRE OP KIT, Medline kit SKU DYKS1163G; 6) PRE OP…11173 unitsClass IIOngoing21 Jan 2026
Z-1058-2026Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) ADMIN KIT, Medline kit SKU DYKS1339B; 2) ADMIN KIT, Medline kit SKU DYKS1339C; 3) QCASC WELCOME KIT, Medline kit SKU DYKS1359B; 4) ADMISSION KIT, Medline kit SKU DYKS1534D.1725 unitsClass IIOngoing21 Jan 2026
Z-1059-2026Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: NEURO ANGIO PACK, Medline kit SKU DYNJ3893512 unitsClass IIOngoing21 Jan 2026
Z-1060-2026Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) RR-PLASTIC CRANIOFACIAL PK-LF, Medline kit SKU DYNJ0395085V; 2) NH PERI DISC PACK, Medline kit SKU DYNJ66311C; 3) DISCECTOMY PACK, Medline kit SKU DYNJ86770; 4) TOTAL KNEE, Medline kit SKU DYNJ909643F.338 unitsClass IIOngoing21 Jan 2026

Context

85%of 2025 device events are Class II945 events that year
12product records in this eventfirm median: 5
66events on this register for the firm

Other enforcement events for Medline Industries, LP

InitiatedProduct (first record)TypeClassRecords
11 Aug 2026Medline Convenience Kits: 1) KIT ANESTHESIA L&D A- LINE SET, Catalog Number: DYKMBNDL199ADeviceClass I7
31 Jul 2026Convenience kits ANESTHESIA PAIN PK LEAGUE DYNJ67925ADeviceClass II4
23 Jul 2026Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008NDeviceClass II1
20 Jul 2026Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators PAIN PRE OP KIT DYKS1476ADeviceClass II13
13 Jul 2026Medline Hudson RCI, DBD-CIRCUIT,VENT,INSPIRATORY,HEATED,NEO, Medline Product Number/SKU HUD78019 (Teleflex Product NumbeDeviceClass II3
10 Jul 2026Medline medical convenience kit labeled as: TRACH TUBE KIT, Medline Kit SKU DYKM2330DeviceClass II1
10 Jul 2026Medline convenience kits labeled as: 1) FEMORAL PACK, Medline Kit SKU DYNJ909393A; 2) FEVAR, Medline Kit SKU DYNJ910295DDeviceClass II11
8 Jul 2026Medline medical convenience kits, labeled as: 1) SINUS PACK-LF, Medline Kit SKU DYNJ0966146F; 2) ENT PACK, Medline Kit SDeviceClass II4
30 Jun 2026Medline Micro-Kill Bleach Germicidal Bleach Wipes,7" x 8", 150 count, 150 count, Product Number MSC351400ANDeviceClass II4
12 Jun 2026Medline Convenience Kits: 1) DRAWER 9 CRICOTHYROTOMY KIT, Model Number: ACC010741; 2) KIT ANESTHESIA L&D A- LINE SET, MoDeviceClass II16

All 66 events for Medline Industries, LP

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "US Nationwide distribution."

Is the recall still ongoing?

FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.