Agency classClass IIOur severity:High FDA (Devices)·Z-0968-2023·Announced 2023-01-25

Cardinal Health Jackson-Pratt Channel Drains recalled for performance defects

Cardinal Health is recalling 4,111 Jackson-Pratt Channel Drains (10 Fr) due to multiple performance issues including dull trocars, broken tips, reduced flexibility, and lack of radiopacity that may affect device function.

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: This is a Class II recall of a surgical device with identified performance defects (broken tips, dull trocars, reduced flexibility, lack of radiopacity) that represent a risk of harm. No reported illnesses or injuries have been documented, meeting the criterion for High severity as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Cardinal Health 200, LLC is recalling the Jackson-Pratt Channel Drain, 10 Fr (REF JP-2187). The recall affects 4,111 devices distributed worldwide, including the United States, Canada, Saudi Arabia, Singapore, and Hong Kong. Affected lot numbers are N210278, N210368, N210423, N210460, N210468, N210469, N210543, N220050, N220099, N220139, and N220163.

Cardinal Health received multiple complaints regarding performance issues with the drains. The identified defects include lack of radiopacity in the wound drain material, dull trocars that may not function as intended, reduced flexibility of the wound drain, and broken wound tips. These issues may impact the device's intended performance during surgical placement and use.

Healthcare institutions and medical professionals who have received affected drains should verify their inventory against the recalled lot numbers. Any affected devices should be managed according to Cardinal Health's recall instructions and applicable medical device regulations.

The recalled product

Product: Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2187
Manufacturer: Cardinal Health 200, LLC
Category: Medical Device — Surgical drain
Hazard: broken-tip
dull-trocar
lack-of-radiopacity
reduced-flexibility
Affected units: 4,111

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 (13)

UDI/DI 50885380182424(cs)
20885380182423(ea)
Lot Numbers: N210278
N210368
N210423
N210460
N210468
N210469
N210543
N220050
N220099
N220139
N220163

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 28 recalled by Cardinal Health 200, LLC 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 28 products in this recall →

Same manufacturer · Cardinal Health 200, LLC

See all →

Severe
Cardinal Health Recalls Presource Packs with Medtronic Microstream Components
FDA (Devices) · 2026-10-14
High
Cardinal Health Recalls Gynecological Laparoscopy Kits Due to Handpiece Leakage
FDA (Devices) · 2026-10-07
High
Cardinal Health Recalls Presource Packs Due to Potential Handpiece Leakage
FDA (Devices) · 2026-10-07
High
Cardinal Health Recalls Stryker StrykeFlow PS and AHTO Tube Set Kits
FDA (Devices) · 2026-10-07
High
Cardinal Health Recalls Presource Packs with Leaking Handpieces
FDA (Devices) · 2026-10-07

Same hazard · broken tip