Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.
Procedure packs: (1) Presource PBDS, Cat. PGMHSUESR, Southeast Hospital MHHS, Kit, Set Up No Drape, SE, Sterile; (2) Presource PBDS Cat. PGVGLBP20, Parkview Medical Center, Kit, Lap Chole, Sterile; (3) Presource PBDS Cat. PG63CCC31, USPI Christ Hosp Spine Srgry C, Kit, Basic, Sterile; (4) Presource PBDS Cat. PG63CCC34, USPI Christ Hosp Spine Srgry C, Kit, Basic, Sterile; (5) Presource Robotic Module Pack, Cat. SBAOCRBENF, Englewood Hospital and Medical, Sterile; (6) Presource Robotic Module Pack, Cat. SBAOCRBEN8, Englewood Hospital and Medical, Sterile; (7) Presource FMC Liver Resection Pack, Cat. SBA30MJCHH, AHS Calgary Zone, Sterile; (8) Presource ALIF Pack, Cat. SBA41ALFME, USPI Baylor Med Ctr at Fri, Sterile; (9) Presource ACDF Pack, Cat. SBA44ACWBF, Webster Surgical Specialty Hos, Sterile; (10) Presource Lap Chole Pack, Cat. SBA54LADNA, USPI Paso Del Norte Srgry Ctr, Sterile; (11) Presource Lap Chole Pack, Cat. SBA54LADN3, USPI Paso Del Nrte Srgry Ctr, Sterile; (12) Presource Salle Hybride Ensemble, Cat. SCV30THLHA, Inst Univ Cardio ET Pneumo, Sterile; (13) Presource AMB Perc Pack, Cat. SMA57PR00B, Oregon Health Science Universi, Sterile; (14) Presource KP Vacaville Lami Pack, Cat. SNE69LPKVB, KP Vacaville, Sterile; (15) Presource Kyphoplasty Pack, Cat. SOP26KPMHB, Moffitt Cancer Center, Sterile; (16) Presource Percutaneous Nephro Pack, Cat. SOT30PELCA, Lakeridge Health Corporation, Sterile; and (17) Presource PBDS Infection Control Turnover Kit, Cat. ORC511687B, Sequoia Surgery Center LLC, Sterile.
Why it was recalled
Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / code information
(1) Cat. PGMHSUESR - Lot #54698, Exp. 2/1/2025 and Exp. 6/1/2024, UDI-DI 10195594542757; (2) Cat. PGVGLBP20 - Lot #921831, Exp. 4/1/2024, UDI-DI 10195594892210; (3) Cat. PG63CCC31 - Lot #940845, Exp. 9/1/2023, UDI-DI 10197106032978; (4) Cat. PG63CCC34 - Lot #46817, Exp. 2/1/2024, UDI-DI 10197106279342; (5) Cat. SBAOCRBENF - Lot #985693, Exp. 7/1/2024, UDI-DI 10195594735999; (6) Cat. SBAOCRBEN8 - Lot #920306, Exp. 6/1/2024, UDI-DI 10195594882334; (7) Cat. SBA30MJCHH - Lot #937398, Exp. 4/1/2025, UDI-DI 10195594759766; (8) Cat. SBA41ALFME - Lot #981380, Exp. 12/1/2024, UDI-DI 10887488946573; (9) Cat. SBA44ACWBF - Lot #986205, Exp. 10/1/2024, UDI-DI 10888439902877; (10) Cat. SBA54LADNA - Lot #998437, Exp. 3/1/2026, UDI-DI 10888439912135; (11) Cat. SBA54LADN3 - Lot #921655, Exp. 2/1/2024, UDI-DI 10195594891275; (12) Cat. SCV30THLHA - Lot #919439, Exp. 1/1/2024, UDI-DI 10195594133559; (13) Cat. SMA57PR00B - Lot #922735, Exp. 3/1/2025, UDI-DI 10195594514259; (14) Cat. SNE69LPKVB - Lot #953055, Exp. 7/1/2024, UDI-DI 10195594578916; (15) Cat. SOP26KPMHB - Lot #17915, Exp. 9/1/2024, Exp. 8/1/2024, and Exp. 1/1/2025, UDI-DI 10888439903133; (16) Cat. SOT30PELCA - Lot #919471, UDI-DI 10195594513665; and (17) Cat. ORC511687B - Lot #18365, UDI-DI 10887488892696.
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, CT, DC, FL, HI, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, and WV. There was government distribution and no military distribution. The country of Canada.
Recall record
- Recalling firm
- Cardinal Health 200, LLC
- Product type
- Devices
- Recall number
- Z-0087-2024
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Letter
- Origin
- Waukegan, IL
- Recall initiated
- 2023-08-16
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall Z-0087-2024 · Source: openFDA enforcement.