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Showing 221–240 of 1734 results

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IV Administration Set (B Braun) – Medication Backflow Risk (2025)

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

FDAOct 29, 2025Nationwide• B Braun Medical Inc

CARESAFE Set (B Braun) – Medication Backflow Risk (2025)

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

FDAOct 29, 2025Nationwide• B Braun Medical Inc

DTT Respiratory Specimen (Copan) – Reagent Functionality Issue (2025)

Treatment reagent functionality in respiratory specimens liquification cannot be guaranteed.

Moderate

FDAOct 29, 2025CA, CO, FL +11 more• Copan Italia Via Francesco Perotti 10

RATE FLOW Set (B Braun) – Medication Backflow Risk (2025)

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

FDAOct 29, 2025Nationwide• B Braun Medical Inc

ADDitIV Set (B Braun) – Medication Backflow Risk (2025)

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

FDAOct 29, 2025Nationwide• B Braun Medical Inc

CT 5300 (Philips) – Scanner Component Detachment (2025)

If the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. This component may become detached and make contact with other components located within the Incisive CT systems during rotation. Other components could be damaged due to the contact with the tube heat exchanger.

FDAOct 29, 2025Nationwide• Philips North America Llc

Welch Allyn INF BAG (Baxter) – Bladder Size Mismatch (2025)

Replacement bladder kit for the Welch Allyn two-piece reusable blood pressure cuff may contain a Large Adult size bladder rather than a Thigh size bladder in the replacement kits.

FDAOct 28, 2025Nationwide• Baxter Healthcare Corporation

NextSeq 550Dx Reagent Kits (Illumina) – Flow Cell Compatibility (2025)

An instrument intended for sequencing DNA libraries with in vitro diagnostic assays is used with reagent kits including flow cells that have flow cell gaskets that have a quality issue, which may lead to flow cell leaks during runs, which could cause run failures, that may result in: No/insufficient data output, instrument fluidics clogs, toxic substance exposure to user.

FDAOct 28, 2025Nationwide• Illumina, Inc.

Fur Friends Adhesive Bandages (Medline) – Packaging Seal Compromise (2025)

Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product.

FDAOct 27, 2025Nationwide

Hemodialysis System Surdial DX (Nipro) – Screw Loosening Risk (2025)

Screw may loosen or fallout of Hemodialysis system

FDAOct 27, 2025Nationwide• Nipro Medical Corporation

Azurion R3.0 (Philips) – SSD Spacer Omission (2025)

Between July 2024 and June 2025, Philips Azurion R3.0 systems with a FlexArm stand were shipped without the Source-to-Skin Distance (SSD) Spacer. The SSD spacer is necessary to meet the FDA minimum source-skin distance requirement of 38 cm for standard fluoroscopy applications.

FDAOct 27, 2025Nationwide• Philips North America

CURAD Germ-Shield Bandages (Medline) – Packaging Seal Compromise (2025)

Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product.

FDAOct 27, 2025Nationwide

Quick Strip Fabric Bandages (Medline) – Packaging Seal Compromise (2025)

Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product.

FDAOct 27, 2025Nationwide

Quick Strip Adhesive Bandages (Medline) – Packaging Seal Compromise (2025)

Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product.

FDAOct 27, 2025Nationwide

Medline Perfusion Syringe (Unknown) – BD Luer Tip Cap Issue (2025)

Laceration Risk

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing BD Luer Tip Caps. BD has issued a recall of their Luer Tip Caps after confirming through internal testing that certain BD Luer Tip Cap trays failed routine biocompatibility testing. Although the tip cap covers a small surface area of the syringe and does not come in direct contact with patients, there is the potential that the failure of a biocompatibility test may have varying consequences ranging from no harm or clinical impact to potential for sensitization, irritation, pyrogenicity, acute systemic toxicity or hemolysis depending on the nature and duration of contact with the syringe.

FDAOct 27, 2025Nationwide

Curad Quick Strip Bandages (Medline) – Packaging Seal Compromise (2025)

Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product.

FDAOct 27, 2025Nationwide

5008X CAREsystem (Fresenius) – Software Anomaly Risk (2025)

Several software anomalies with the potential to impact patient treatment, of which one includes the possibility to result in treatment stop if certain conditions are fulfilled.

FDAOct 25, 2025LA, MA, MN• Fresenius Medical Care Holdings, Inc.

MAMMOMAT Revelation (Siemens) – Incorrect Table Installation (2025)

There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.

FDAOct 24, 2025Nationwide• Siemens Medical Solutions USA, Inc

MAMMOMAT Inspiration (Siemens) – Incorrect Table Installation (2025)

There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.

FDAOct 24, 2025Nationwide• Siemens Medical Solutions USA, Inc

Senographe Pristina (GE Medical) – X-Ray Warning Label Missing (2025)

Some Senographe Pristina systems either have a missing or an incorrect X-Ray Warning label, which is a nonconformance to FDA Regulation 21 CFR 1020.30(j).

FDAOct 24, 2025Nationwide• GE Medical Systems, LLC

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