Jackson-Pratt Surgical Drain Kits Recalled for Unsterilized Shipments
Cardinal Health is voluntarily recalling Jackson-Pratt 3-Spring surgical drain kits from specific lot numbers that were shipped unsterilized. Distributed worldwide including the US, the kits pose an infection risk if used without sterilization.
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 an FDA Class II medical device recall for non-sterile surgical drain kits. No illnesses or injuries have been reported, placing it in the High category as a risk-of-harm product without documented injury.
Plain-English summary
Cardinal Health 200, LLC is voluntarily recalling Jackson-Pratt 3-Spring Reservoir with Silicone Adapters (400mL, REF SU130-475) because specific products in one lot were shipped to customers before completing the sterilization process. The product is a surgical drain used in post-operative care.
The recall is limited to Lot Number 231251D5, affecting approximately 98 cases of 12 units each. Distribution was worldwide, including the entire United States and the countries of Panama, Guatemala, Chile, Costa Rica, and Caribbean Islands.
Unsterilized medical devices can harbor bacteria and other pathogens, creating a risk of infection. Customers with products from the affected lot should not use them and should contact Cardinal Health for guidance on returns or replacements.
The recalled product
- Product
- Jackson-Pratt 3-Spring Reservoir with Silicone Adapters, 400mL, REF SU130-475
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Surgical Drain
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 (3)
- UDI/DI 50885380113114 (Case)
- 10885380113116 (Each)
- Lot Numbers: 231251D5
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 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 5 products in this recall →Related recalls
Same manufacturer · Cardinal Health 200, LLC
See all →- SevereCardinal Health Recalls Presource Packs with Medtronic Microstream Components
FDA (Devices) · 2026-10-14
- HighCardinal Health Recalls Gynecological Laparoscopy Kits Due to Handpiece Leakage
FDA (Devices) · 2026-10-07
- HighCardinal Health Recalls Presource Packs Due to Potential Handpiece Leakage
FDA (Devices) · 2026-10-07
- HighCardinal Health Recalls Stryker StrykeFlow PS and AHTO Tube Set Kits
FDA (Devices) · 2026-10-07
- HighCardinal Health Recalls Presource Packs with Leaking Handpieces
FDA (Devices) · 2026-10-07
Same hazard · non sterile
See all →- SevereBeekeeper's Naturals saline nasal spray recalled for microbial contamination
FDA (Drugs) · 2026-06-17
- HighMedline Medical Convenience Kits Recalled for Non-Sterile Alcohol Prep Pads
FDA (Devices) · 2026-05-06
- HighMedline IV Start and Securement Kits Recalled for Non-Sterile Alcohol Prep Pads
FDA (Devices) · 2026-05-06
- HighMedline and Centurion Medical Convenience Kits Recalled for Non-Sterile Alcohol Prep Pads
FDA (Devices) · 2026-05-06
- HighMedline medical convenience kits recalled for non-sterile alcohol prep pads
FDA (Devices) · 2026-05-06
Similar recalls
- HighCardinal Health Recalls Jackson-Pratt Silicone Flat Drains Due to Sterility Concerns
FDA (Devices) · 2017-05-31
- HighCardinal Health Recalls Jackson-Pratt Silicone Round Drains Due to Sterility Concerns
FDA (Devices) · 2017-05-31
- HighCardinal Health Recalls Jackson-Pratt Silicone Round Drains Due to Seal Compromise
FDA (Devices) · 2017-05-31
- HighCardinal Health Recalls Jackson-Pratt Wound Drains Due to Sterility Concerns
FDA (Devices) · 2017-05-31
- HighCardinal Health Recalls Jackson-Pratt Hemaduct Silicone Round Drains
FDA (Devices) · 2017-05-31
- HighCardinal Health Recalls Jackson-Pratt Hemaduct Silicone Flat Drains
FDA (Devices) · 2017-05-31