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Showing 1161–1180 of 68218 results

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Sodium Chloride Irrigation (B Braun Medical) - Sterility Concern (2025)

Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.

Class IIModerate

FDAAug 26, 2025Nationwide• B BRAUN MEDICAL INC

Cream Caramels (Abdallah) – undeclared nuts (2025)

Undeclared Allergen

Undeclared allergen (peanut, pecan).

Class IIModerate

FDAAug 25, 2025PA• Abdallah Incorporated

Artegraft Collagen Vascular Graft (LeMaitre) – Incorrect Labeling (2025)

Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.

Low

FDAAug 25, 2025Nationwide• LeMaitre Vascular, Inc.

Chlorpromazine Hydrochloride 100mg Tablets (AvKARE) - Foreign Substance (2025)

Presence of a foreign substance.

Class IIModerate

FDAAug 25, 2025Nationwide• AvKARE

TopCare Health Isopropyl Alcohol (Consumer Product Partners) - Contamination (2025)

Cross Contamination with Other Products.

FDAAug 25, 2025Nationwide• Consumer Product Partners, LLC

Chlorpromazine Hydrochloride Tablets (AvKARE) - Foreign Substance (2025)

Presence of a foreign substance.

Class IIModerate

FDAAug 25, 2025Nationwide• AvKARE

Kroger Isopropyl Alcohol (Consumer Product Partners) - Contamination (2025)

Cross Contamination with Other Products.

FDAAug 25, 2025Nationwide• Consumer Product Partners, LLC

Sea Salt Caramel Dark Miniature (Abdallah) – undeclared nuts (2025)

Undeclared Allergen

Undeclared allergen (peanut, pecan).

Class IIModerate

FDAAug 25, 2025PA• Abdallah Incorporated

Sofmed Breathables Lens (CooperVision) – Sterilization Cycle (2025)

One lot manufactured with an invalid sterilization cycle.

FDAAug 22, 2025Nationwide• CooperVision, Inc.

Sonesta 6210 Fluoroscopy Table (Sonesta) – Weld Bracket Weakness (2025)

Video fluoroscopy table may contain inadequate weld on backrest bracket resulting in backrest dropping.

FDAAug 22, 2025NH• Sonesta Medical AB Industrivagen

MyDay Toric Lens (CooperVision) – Sterilization Cycle (2025)

One lot manufactured with an invalid sterilization cycle.

FDAAug 22, 2025Nationwide• CooperVision, Inc.

MAC VU360 Cable (GE Medical) – Module Placement Risk (2025)

If a user incorrectly places the Acquisition Module into the Acquisition Module Holder, it can result in excessive bending and wear of the Acquisition Trunk Cable. This is visible as a damaged sheath or exposed wires. If a damaged Acquisition Trunk Cable is not recognized and removed from service, the cable can overheat with continued use.

FDAAug 22, 2025Nationwide• GE Medical Systems, LLC

Voyant 1-Day Toric Lens (CooperVision) – Sterilization Cycle (2025)

One lot manufactured with an invalid sterilization cycle.

FDAAug 22, 2025Nationwide• CooperVision, Inc.

Ultra Violette SPF Mates Kit (Grace & Fire) - Inconsistent SPF Protection (2025)

Subpotent/Super-potent Product: Testing of the SPF 50 sunscreen revealed inconsistency in SPF results ranging from SPF 4, 10, 21, 26, 33, 60, 61, and 64.

Class IIModerate

FDAAug 22, 2025Nationwide• GRACE & FIRE PTY LTD

Velvet Screen SPF 50 (Grace & Fire) - Inconsistent SPF Protection (2025)

Subpotent/Super-potent Product: Testing of the SPF 50 sunscreen revealed inconsistency in SPF results ranging from SPF 4, 10, 21, 26, 33, 60, 61, and 64.

Class IIModerate

FDAAug 22, 2025Nationwide• GRACE & FIRE PTY LTD

i-STAT EG7+ Cartridge (Abbott) – Sample Type Issue (2025)

Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and measurement ranges for pH and PO2.

FDAAug 21, 2025Nationwide• Abbott Point Of Care Inc.

Frontier 12mm Distraction Pin (Folsom) – Shelf Life Concern (2025)

Labeling includes shelf life that has not been validated.

FDAAug 21, 2025Nationwide• Folsom Metal Products, Inc.

i-STAT EG6+ Cartridge (Abbott) – Sample Type Issue (2025)

Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and measurement ranges for pH and PO2.

FDAAug 21, 2025Nationwide• Abbott Point Of Care Inc.

Medline Valve Pack (Unknown) – Catheter Shape Retention (2025)

The kits contain certain lots of cannula products where the catheter may not retain its shape.

FDAAug 21, 2025Nationwide

Frontier 14mm Distraction Pin (Folsom) – Shelf Life Concern (2025)

Labeling includes shelf life that has not been validated.

FDAAug 21, 2025Nationwide• Folsom Metal Products, Inc.

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