Agency classClass IIOur severity:High FDA (Devices)·Z-1094-2023·Announced 2023-02-15

Sterile Procedural Trays Recalled Due to Blade Puncture Risk

MEDLINE INDUSTRIES is recalling sterile surgical trays used in robotic and laparoscopic procedures because blades within the kits can puncture the outer foil packaging. The recall affects 1,212 cases (2,101 units) distributed worldwide.

The agency’s classification

FDA (Devices): Class II

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.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard represents a risk-of-harm scenario where blade puncture could compromise the sterile packaging of surgical instruments, meeting the rubric criterion for High severity.

Plain-English summary

MEDLINE INDUSTRIES, LP is recalling multiple sterile procedural trays used in robotic-assisted and laparoscopic surgeries. The recall affects 1,212 cases containing 2,101 units across various product configurations.

Sterile blades within these surgical kits have the potential to puncture the outer foil layer of the sterile packaging. This could compromise the sterile condition of the surgical instruments.

These products were distributed worldwide, including throughout the United States, Canada, Japan, Mexico, Panama, Turks & Caicos, and the United Arab Emirates.

Affected healthcare facilities should contact MEDLINE INDUSTRIES or review the FDA recall notice for instructions on how to proceed with affected inventory.

The recalled product

Product: Sterile Procedural Trays, labeled as the following: a. CELEBRATION ROBOTIC CDS b. DAVINCI CDS UCC-LF c. ROBOTICS PACK-LF d. ROBOTICS PACK-LF e. ROBOTIC PACK f. PELVISCOPY PACK-LF g. CUSTOM LITHOTOMY ROBOT PACK h. PERI GYN PACK i. ROBOTICS PACK j. LAP HYSTO PACK k.…
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Category: Medical Device — Surgical Trays
Hazard: packaging-puncture
sterility-risk

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. CELEBRATION ROBOTIC CDS
Item Number: CDS983612C
Case UDI/GTIN: 40884389768687
Unit UDI/GTIN: 10884389768686
Lot Number: 22KBE707
22JBX839
22JBX843
b. DAVINCI CDS UCC-LF
Item Number: CDS984663G
Case UDI/GTIN: 40193489323772
Unit UDI/GTIN: 10193489323771
Lot Number: 22JBX614
c. ROBOTICS PACK-LF
Item Number: DYNJ0038258B
Case UDI/GTIN: 40889942902089
Unit UDI/GTIN: 10889942902088
Lot Number: 22IBO524
22HBV626
22HBV627
d. ROBOTICS PACK-LF

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 38 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 38 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 · packaging puncture