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regard Clinical Packaging Solutions, HT00376I - SPECIAL P... (ROi CPS LLC) – medical convenience kits were distrib... (2024)

Medical convenience kits were distributed with Merit syringes (manufactured by Jiangsu Shenli Medical Production) which were subsequently recalled.

High

FDAJul 24, 2024Nationwide• ROi CPS LLC

Stryker iBur 3.0mm Coarse Diamond Round, Distal Bend - in... (Stryker Corporation) – potential for the product to exhibit ... (2024)

Potential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Temperatures higher than specification may lead to the potential for minor tissue/structure damage or tissue/structure damage from thermal injury which may need medical/surgical intervention.

High

FDAJul 24, 2024Nationwide• Stryker Corporation

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regard Clinical Packaging Solutions, HT00376I - SPECIAL P... (ROi CPS LLC) – medical convenience kits were distrib... (2024)

Stryker iBur 3.0mm Coarse Diamond Round, Distal Bend - in... (Stryker Corporation) – potential for the product to exhibit ... (2024)

FreeStyle Libre 3 Sensors, REF: 72081-01, component of th... (Abbott Diabetes Care, Inc.) – laceration hazard (2024)

Stryker iBur 4.0mm Diamond Round, Distal Bend- intended t... (Stryker Corporation) – potential for the product to exhibit ... (2024)

Stryker iBur 3.0mm Precision Round, Distal Bend- Intended... (Stryker Corporation) – potential for the product to exhibit ... (2024)

Stryker iBur 2.0mm Diamond Round, Distal Bend- intended t... (Stryker Corporation) – potential for the product to exhibit ... (2024)

McKesson Syringe 60CC, Luer Lock Tip, Sterile, ITEM NO 10... (Cypress Medical Products LLC) – affected syringes lack fda clearance (2024)

(a) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 1... (Cardinal Health 200, LLC) – the firm received reports of breakage... (2024)

CARDIOVIT AT-180. Model Number: 0A.110000; Catalog number... (Schiller, Ag Altgasse 68 Baar Switzerland) – potential for high-frequency signal a... (2024)

Stryker iBur 3.0mm Precision Match Head, Distal Bend- in... (Stryker Corporation) – potential for the product to exhibit ... (2024)

Coconutmilk Chocolate Almond Crunch (Full Circle) – Undeclared Cashews (2024)

Sodium Chloride Injection (B. Braun) – Particulate Matter (2024)

Stryker iBur 4.0mm Precision Round, Distal Bend- intended... (Stryker Corporation) – potential for the product to exhibit ... (2024)

Stryker iBur 3.0mm Diamond Round, Distal Bend - intended ... (Stryker Corporation) – potential for the product to exhibit ... (2024)

Stryker iBur 5.0mm Coarse Diamond Round, Distal Bend in... (Stryker Corporation) – potential for the product to exhibit ... (2024)

Stryker iBur 4.0mm Coarse Diamond Round, Distal Bend - in... (Stryker Corporation) – potential for the product to exhibit ... (2024)

Karl Storz - Endoskope , REF: 27294AA, Hopkins Telescope ... (Karl Storz Endoscopy) – various medical device product ifus c... (2024)

Karl Storz - Endoskope , REF: 27830KA, Nephroscope for MI... (Karl Storz Endoscopy) – various medical device product ifus c... (2024)

Karl Storz - Endoskope , REF: 27292AMA, Hopkins Telescope... (Karl Storz Endoscopy) – various medical device product ifus c... (2024)

GE Healthcare Centricity Universal Viewer Zero Footprint ... – fire hazard (2024)