Cardinal Health Recalls Surgical Procedure Packs With Recalled Components
Cardinal Health is recalling 13,351 procedure packs used in surgical procedures because they contain recalled components. The affected packs were distributed nationwide and in Canada.
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 of surgical procedure packs with no reported illnesses or injuries in the source. These are medical devices used in surgical procedures where component failures could pose risks. Per the rubric, this is classified as a risk-of-harm product where injury has not yet been reported, supporting a High severity rating.
Plain-English summary
Cardinal Health 200, LLC is recalling 13,351 procedure packs designated as Presource PBDS Cat. PLMHCSBHF, which are used in surgical procedures including C-section deliveries. The procedure packs contain equipment drapes, table covers, and surgical room turnover (SRT) kits that have been identified as recalled components.
The recalled packs were distributed nationwide across 33 US states, Washington DC, Hawaii, and the country of Canada. The affected lots are Lot #81461 with expiration dates of June 1, 2024 and September 1, 2024 (UDI-DI: 10195594542795).
Healthcare facilities and surgical centers that have received these procedure packs should review their inventory against the lot numbers and expiration dates. Any affected packs should be removed from use. Facilities should contact Cardinal Health for instructions regarding return or disposal of the recalled products.
The recalled product
- Product
- Procedure pack: Presource PBDS Cat. PLMHCSBHF, Hermann Hospital MHHS, Kit, C Section B MHHS, Sterile.
- Manufacturer
- Cardinal Health 200, LLC
- Hazard
- Affected units
- 13,351
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)
- Lot #81461
- Exp. 6/1/2024 and Exp. 9/1/2024
- UDI-DI 10195594542795.
Distribution
Part of a larger recall action
This product is one of 10 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 10 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 · device defect
See all →- SevereBard Access Systems Recalls Power-Trialysis Dialysis Catheters
FDA (Devices) · 2026-09-23
- SevereBoston Scientific ENROUTE Transcarotid Neuroprotection System Recall for Tip Separation
FDA (Devices) · 2026-08-26
- HighMicrovention Recalls Bobby Balloon Guide Catheters Due to Pinhole Defects
FDA (Devices) · 2026-08-19
- SevereMedtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77722
FDA (Devices) · 2026-08-05
- SevereAbiomed Impella CP Smart Assist Set Heart Pump Introducer Sheath Leakage
FDA (Devices) · 2026-07-22
Similar recalls
- CriticalCardinal Health Recalls Presource Shoulder Procedure Kits Due to Airflow Risk
FDA (Devices) · 2013-05-15
- HighCardinal Health Surgical Kits Recalled for Potential Endotoxin Contamination
FDA (Devices) · 2025-01-22
- HighCardinal Health Presource Surgical Kits Recalled for Endotoxin Contamination
FDA (Devices) · 2025-01-22
- HighCardinal Health Recalls Presource Procedure Packs Due to Sterility Concerns
FDA (Devices) · 2020-02-26
- HighCardinal Health Presource Surgical Kits Recalled for Potential Endotoxin Contamination
FDA (Devices) · 2025-01-22
- HighCardinal Health Presource Kits recalled for endotoxin contamination risk
FDA (Devices) · 2025-02-19