Agency classClass IOur severity:Severe FDA (Devices)·Z-1106-2024·Announced 2024-03-06

MEDLINE Surgical Kits Recalled Due to Potential Sterility Failure

MEDLINE is recalling surgical kits, trays, and packs due to potential lack of sterility in component solutions. The recalled products were distributed nationwide and internationally.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This recall is classified as FDA Class I. Per the rubric, FDA Class I medical device recalls carry a minimum severity score of 4 (Severe), even absent reported illnesses or injuries.

Plain-English summary

MEDLINE Industries, LP is recalling certain surgical kits, trays, and packs used in medical procedures. These products contain component solutions from Nurse Assist: 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP, and Saline Flush Syringe. The recall was initiated due to a potential lack of sterility in these components.

The recalled MEDLINE products include: ENDO KIT (REF DYKE1350D), PANENDOSCOPY-LF (REF DYNJ36728C), and UMBILICAL VESSEL INSERTION kits (REF UVT1170 and UVT1170H). The products have been distributed nationwide across the United States, including Puerto Rico, and internationally to Canada, United Arab Emirates, and Panama.

This is an FDA Class I recall (number Z-1106-2024).

The recalled product

Product: MEDLINE Kits, trays, and packs labeled as follows: a) ENDO KIT, REF DYKE1350D; b) PANENDOSCOPY-LF, REF DYNJ36728C; c) UMBILICAL VESSEL INSERTION, REF UVT1170; d) UMBILICAL VESSEL INSERTION, REF UVT1170H
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Category: Medical Device — Surgical Kits
Hazard: lack-of-sterility
contamination
Affected units: 1,184

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

a) REF DYKE1350D
UDI/DI 40193489339797 (case)
10193489339796 (unit)
Lot Numbers: 22FBT089
22LBN853
23CBI535
23DBQ149
23EBI601
b) REF DYNJ36728C
UDI/DI 40193489265911 (case)
10193489265910 (unit)
Lot Numbers: 22BBJ543
22FBD924
22HBR956
23BBF230
23FBG752
c) REF UVT1170
UDI/DI 40653160991244 (case)
10653160991243 (unit)
Lot Numbers: 21LBK307

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 49 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 49 products in this recall →

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

See all →

Critical
Intubation trays recalled after laryngoscope handle lights failed to illuminate
FDA (Devices) · 2025-10-01
Severe
Medline Medical Convenience Kits with Defective Laryngoscope Handles
FDA (Devices) · 2025-10-01
High
Good Neighbor alcohol prep pads recalled for alcohol below labeled concentration
FDA (Drugs) · 2025-09-03
High
Surgical kits recalled because Foley tray inserts carry incorrect product information
FDA (Devices) · 2025-09-03
High
Surgery trays recalled because they contain recalled tourniquet cuffs
FDA (Devices) · 2025-09-03

Same hazard · lack of sterility