The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the floor. The impact can range from user dissatisfaction to the potential for the user of slip and fall.

Waukegan, IL, US · Updated 9/25/2026, 12:00:00 AM UTC

Source: FDA — device enforcement reference

Reference notice · device

Cardinal Health 200, LLC — Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, LAP CHOLE , Catalog Number: PGCGLCBAC; 2) KIT, LAP CHOLE , Catalog Number: PGCGLCBAD; 3) KIT, LAP CHOLE

The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the floor. The impact can range from user dissatisfaction to the potential for the user of slip and fall.

Waukegan, IL, US · Updated 9/25/2026, 12:00:00 AM UTC

Source: FDA — device enforcement reference

Reference notice · device

Cardinal Health 200, LLC — Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, GYN LAPAROSCOPY NEW HAN , Catalog Number: PB23GLNLAC; 2) KIT, GYN LAPAROSCOPY NEW HAN , Catalog Number:

The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the floor. The impact can range from user dissatisfaction to the potential for the user of slip and fall.

Waukegan, IL, US · Updated 9/25/2026, 12:00:00 AM UTC

Source: FDA — device enforcement reference

Reference notice · device

Cardinal Health 200, LLC — Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, LAVH , Catalog Number: PB63VHSTC

The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the floor. The impact can range from user dissatisfaction to the potential for the user of slip and fall.

Waukegan, IL, US · Updated 9/25/2026, 12:00:00 AM UTC

Source: FDA — device enforcement reference

Reference notice · device

Baxter Healthcare Corporation — PRO+ 40" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves to provide weight-based pressure redistribution whe

There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved product or product specifications and may lead to incorrect product identification or selection, potentially resulting in use with an incompatible bed frame.

Deerfield, IL, US · Updated 9/24/2026, 12:00:00 AM UTC

Source: FDA — device enforcement reference

Reference notice · device

Baxter Healthcare Corporation — PRO+ MRS SURFACE FOR VERSACARE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves to provide weight-based pressure redistri

There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved product or product specifications and may lead to incorrect product identification or selection, potentially resulting in use with an incompatible bed frame.

Deerfield, IL, US · Updated 9/24/2026, 12:00:00 AM UTC

Source: FDA — device enforcement reference

Reference notice · device

Baxter Healthcare Corporation — PRO+ 36" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves to provide weight-based pressure redistribution whe

There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved product or product specifications and may lead to incorrect product identification or selection, potentially resulting in use with an incompatible bed frame.

Deerfield, IL, US · Updated 9/24/2026, 12:00:00 AM UTC

Source: FDA — device enforcement reference

Reference notice · food

KRAFT HEINZ FOODS COMPANY — Heinz Real - Vraie Mayonnaise, 12.5ml single serving packet, 500 packets per case, case code 57000 06672

undeclared ingredients including but not limited to mustard

Chicago, IL, US · Updated 9/23/2026, 12:00:00 AM UTC

Source: FDA — food enforcement reference

Reference notice · device

ICU Medical, Inc. — CADD Yellow Medication Cassette Reservoir with NRFit connector US Product Codes: 21-7600-24, 21-7609-24 OUS Product Codes: 21-7609-24 21-7600-24 21-7600-24 21-7600-24 21-7609-24 21

Reservoirs may exhibit medication leakage at the joint between luer connector and tubing. Issue could result in delay or interruption of therapy, under delivery of medication, exposure to infectious or toxic agents, or air embolus.

Lake Forest, IL, US · Updated 9/17/2026, 12:00:00 AM UTC

Source: FDA — device enforcement reference

Reference notice · drug

Baxter Healthcare Corporation — Dextrose Injection, USP, 70 %, 2000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL, 60016, Made in USA, NDC 00338-0719-06

Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.

Deerfield, IL, US · Updated 9/16/2026, 12:00:00 AM UTC

Source: FDA — drug enforcement reference

Reference notice · device

Medline Industries, LP — Medline Convenience Kits: 1) KIT ANESTHESIA L&D A- LINE SET, Catalog Number: DYKMBNDL199A

The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences…

Northfield, IL, US · Updated 9/14/2026, 12:00:00 AM UTC

Source: FDA — device enforcement reference

Reference notice · device

Medline Industries, LP — Medline Convenience Kits: 1) DYNDB3086D, Catalog Number: DYNDB3086D; 2) DYNDB3100, Catalog Number: DYNDB3100; 3) DYNDH1619A, Catalog Number: DYNDH1619A; 4) DYNDH1620A, Catalog Numb

The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences…

Northfield, IL, US · Updated 9/14/2026, 12:00:00 AM UTC

Source: FDA — device enforcement reference

Reference notice · device

Medline Industries, LP — Medline Convenience Kits: 1) DYKM1000B, Catalog Number: DYKM1000B; 2) DYKM2187A, Catalog Number: DYKM2187A

The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences…

Northfield, IL, US · Updated 9/14/2026, 12:00:00 AM UTC

Source: FDA — device enforcement reference

Reference notice · device

Medline Industries, LP — Medline Convenience Kits: 1) DYNDH1193, Catalog Number: DYNDH1193; 2) DYNDH1487A, Catalog Number: DYNDH1487A

The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences…

Northfield, IL, US · Updated 9/14/2026, 12:00:00 AM UTC

Source: FDA — device enforcement reference

Reference notice · device

Medline Industries, LP — Medline Convenience Kits: 1) OPEN HEART ADULT, Catalog Number: CDS840396Y; 2) FULL LINE ANEURYSM CDS, Catalog Number: CDS983672O; 3) NON STERILE CHEST TUBE REMOVAL, Catalog Number:

The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences…

Northfield, IL, US · Updated 9/14/2026, 12:00:00 AM UTC

Source: FDA — device enforcement reference

Reference notice · device

Medline Industries, LP — Medline Convenience Kits: 1) ACC010308A, Catalog Number: ACC010308A; 2) ACC010374A, Catalog Number: ACC010374A; 3) ACC010679, Catalog Number: ACC010679; 4) ACC010726A, Catalog Numb

The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences…

Northfield, IL, US · Updated 9/14/2026, 12:00:00 AM UTC

Source: FDA — device enforcement reference

Illinois — TradePilot Recalls