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Showing 1981–2000 of 68218 results

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Volcano Visions IVUS Catheter (Volcano) – Entanglement Risk (2025)

Reports of IVUS catheter and guide wire entanglement during radial-to-peripheral procedures, due to catheter use without appropriate sheath and/or guide catheter, which may require further intervention, such as surgical removal; Firm is restating instructions for use and adding: "Use a guide sheath of appropriate length to provide adequate support to the rapid exchange IVUS catheter and guidewire"

FDAJun 13, 2025Nationwide• Volcano Corp

B12 Supplement (Vitalabs) – undeclared peanuts (2025)

Undeclared Nuts

Undeclared Peanuts. The firm was notified by their supplier, that the product may contain undeclared peanuts.

Class IIModerate

Jun 13, 2025

IL, NJ

• Vitalabs, Inc.

Cucumbers (Fuentes Farms) – salmonella risk (2025)

Cucumbers have the potential to be contaminated with Salmonella

FDAJun 13, 2025TX• FUENTES FARMS LLC

Shelled Edamame (Alpine) – soy undeclared (2025)

Label declares Shelled Edamame but does not specify or declare soy.

Class IIModerate

FDAJun 13, 2025CA, ID, IN +2 more• Alpine Food DIstributing, Inc

EasiSlush Solution (Bridge to Life) – Audit Timing Issue (2025)

The firm issued a field safety notice after becoming aware of three lots of products not having quarterly dose audits being completed on time in the first quarter of 2024. Routine lot by lot testing was completed properly however the quarterly dose audit (sampling/testing to monitor the gamma sterilization process and confirm the validated parameters remain effective to assure sterility and bioburden reduction per requirements) was not completed on time.

FDAJun 12, 2025Nationwide• Bridge to Life Ltd

Acuvue Oasys Max Multifocal (Johnson & Johnson) – Lens Defect (2025)

Due to defects (bubbles/voids) identified during standard finished goods testing

FDAJun 12, 2025Nationwide• Johnson & Johnson Vision Care, Inc.

Estrone RIA (Immunotech) – Result Accuracy Concern (2025)

Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary injury of Remote probability or rarely give falsely low patient results which might cause Permanent injury of Remote probability. Only in some (very rare) cases may the issue occur.

FDAJun 12, 2025Nationwide• Immunotech A.S. Radiova 1 Prague

Medline Convenience Kits (Medline) – BD ChloraPrep Seal Issue (2025)

Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by BD due to potential to exhibit an open seal on its packaging. This may constitute a breach to sterility, which may in turn lead to the infection related harms for the patient.

FDAJun 12, 2025CA, FL, PA +1 more• MEDLINE INDUSTRIES, LP Northfield

Frederik's Dark Chocolate Almonds – undeclared cashews (2025)

Undeclared Allergen

undeclared cashews

Class IIModerate

FDAJun 12, 2025IL, IN, KY +3 more• Meijer, Inc #816 - Grand River Packaging

EMPOWR Acetabular (Unknown) – Packaging Discrepancy (2025)

Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued discovered via a customer complaint.

FDAJun 12, 2025AL, CA, FL +11 more

Estrone RIA (Beckman Coulter) – BSA Lot Variation (2025)

A specific lot of bovine serum albumin (BSA) used for manufacturing of coated tubes (CT) that are included in the Estrone RIA kit lots caused different affinity of manufactured coated tubes to patient samples, causing falsely increased assay results for the impacted Estrone RIA kits.

FDAJun 12, 2025NC• Beckman Coulter Inc.

VITROS Chemistry OP Reagent (Ortho-Clinical) – QC Result Concern (2025)

Lots from Generation (GEN) 15 of VITROS Chemistry Products OP Reagent may generate lower than expected quality control (QC) results. If the customer is unable to get passing quality control results, then the customer would be unable to run the OP-LO protocol leading to a potential delay in patient results.

FDAJun 12, 2025Nationwide• Ortho-Clinical Diagnostics, Inc.

Partial Nephrectomy Robotic (AVID Medical) – Visualization System Error (2025)

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

FDAJun 11, 2025CA, IL, MD +4 more• AVID Medical, Inc.

Gen Laparoscopy Pack (Avid Medical) – Visualization System Discoloration (2025)

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

FDAJun 11, 2025CA, IL, MD +4 more• AVID Medical, Inc.

Partial Nephrectomy Pack (Avid Medical) – Visualization System Discoloration (2025)

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

FDAJun 11, 2025CA, IL, MD +4 more• AVID Medical, Inc.

HSG Procedure Tray (CooperSurgical) – Iodine Pouch Labeling (2025)

The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, however the peel away lid labels incorrectly identify the iodine pouches as sterile.

FDAJun 11, 2025Nationwide• CooperSurgical, Inc.

Robotic Uro/GYN Pack (AVID Medical) – Visualization System Error (2025)

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

FDAJun 11, 2025CA, IL, MD +4 more• AVID Medical, Inc.

Laparoscopy Pack (AVID Medical) – Visualization System Error (2025)

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

FDAJun 11, 2025CA, IL, MD +4 more• AVID Medical, Inc.

GYN Laparoscopy Pack (AVID Medical) – Visualization System Error (2025)

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

FDAJun 11, 2025CA, IL, MD +4 more• AVID Medical, Inc.

Laparoscopic Prostatectomy (AVID Medical) – Visualization System Error (2025)

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

FDAJun 11, 2025CA, IL, MD +4 more• AVID Medical, Inc.

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