Recent post-market surveillance data suggests a possible association of higher microbial contamination levels from TJF duodenoscopes when manual cleaning was delayed beyond one hour and a presoak was performed, compared to those TJF duodenoscopes where manual cleaning began within one hour after patient procedure.

Moderate

FDAMay 5, 2025Nationwide• Olympus Corporation of the Americas

Dexcom G7 iOS App (Dexcom) – Glucose Value Bug (2025)

A bug in the 2.7.0 version of the G7 iOS App can cause the app to enter a state where it stops updating the estimated glucose value (EGV) and continues to show this stale EGV. If the user is unaware that the EGVs are not being updated and that glucose alerts will not trigger, there is potential for the missed detection of a hyperglycemic or hypoglycemic event or a treatment decision made based off incorrect data. There is no impact to transmitter communication with concurrently connected displays. A concurrently connected receiver, Apple Watch, and/or insulin pump will continue to receive EGVs directly from the transmitter when the app is in the problematic state. There is no impact to Automated Insulin Dosing (AID) therapy as the AID system continues to receive EGVs directly from the transmitter.

High

FDAMay 5, 2025Nationwide• Dexcom, Inc.

Porsche Taycan (Porsche) – Occupant Classification Error (2025)

Porsche Cars North America, Inc. (Porsche) is recalling certain 2022-2023 Taycan vehicles. An occupant classification system error may deactivate the front passenger air bag.

High

NHTSAMay 5, 2025Nationwide• PORSCHE

SAFE-T-FILL Capillary (ASP Global) – False Positive Results (2025)

All RAM SAFE-T-FILL Micro Capillary Blood Collection tubes manufactured between July 31, 2023 to February 28, 2025 cause false positive results when used with Magellan Diagnostics LeadCare Testing Systems. False positive lead results may cause delayed results and additional unnecessary testing.

Moderate

FDAMay 5, 2025Nationwide• ASP Global, LLC. dba Anatomy Supply Partners, LLC.

Prevost X3-45 VIP (Prevost) – Control Arm Fastener (2025)

Prevost Car (US) Inc. (Prevost) is recalling one 2025 X3-45 VIP Entertainer vehicle. The front lower control arm fasteners may have been improperly tightened, which can result in control arm separation.

Very High

NHTSAMay 5, 2025Nationwide• PREVOST

Access Testosterone Assay (Beckman Coulter) – Maintenance Error (2025)

Inadequate preventative maintenance (PM) performed on the scales of the RPL5 fill line, led to splashing (cross-contamination) between the wells of testosterone reagent packs lot 538081, which could potentially result in up to a 34% increase or a 23% decrease in patient results.

Moderate

FDAMay 5, 2025FL• Beckman Coulter, Inc.

Umbilical Vessel Catheter (Cardinal Health) – Sterility Compromise (2025)

Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.

High

FDAMay 2, 2025Nationwide• Cardinal Health 200, LLC

Umbilical Vessel Catheter (Cardinal Health) – Sterility Compromise (2025)

Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.

High

FDAMay 2, 2025Nationwide• Cardinal Health 200, LLC

Umbilical Vessel Catheter (Cardinal Health) – Sterility Compromise (2025)

Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.

High

FDAMay 2, 2025Nationwide• Cardinal Health 200, LLC

LifeShield Infusion Software (ICU Medical) – Drug Library Defects (2025)

Firm has identified Drug Library Management defects in the software: 1) DLM software does not allow user to create percentage dose rate or rate change values with certain limits, potentially resulting in over-delivery to patient. 2) An unauthorized user may modify and approve a drug library, potentially leading to incorrect program parameters being used for therapy.

High

FDAMay 2, 2025Nationwide• ICU Medical, Inc.

Umbilical Vessel Catheter (Cardinal Health) – Sterility Compromise (2025)

Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.

High

FDAMay 2, 2025Nationwide• Cardinal Health 200, LLC

Umbilical Vessel Catheter (Cardinal Health) – Sterility Compromise (2025)

Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.

High

FDAMay 2, 2025Nationwide• Cardinal Health 200, LLC

Umbilical Vessel Catheter (Cardinal Health) – Sterility Compromise (2025)

Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.

High

FDAMay 2, 2025Nationwide• Cardinal Health 200, LLC

Campsite Reserve (Forest River) – Solar Controller Wiring (2025)

Fire/Burn Risk

Forest River, Inc. (Forest River) is recalling certain 2025 Campsite Reserve travel trailers. The solar controller may be wired incorrectly without over current circuit protection.

Moderate

NHTSAMay 2, 2025Nationwide• FOREST RIVER

BD BBL CultureSwab (Copan) – Swab Breakage Risk (2025)

Swabs for specimen collection may be prone to breakage during product usage.

Moderate

FDAMay 2, 2025Nationwide• Copan Italia Via Francesco Perotti 10

Mercedes-Benz C 300 (Mercedes-Benz) – Seat Belt Cover (2025)

Mercedes-Benz USA, LLC (MBUSA) is recalling certain 2022-2025 C 300, and 2023-2024 AMG C 43 vehicles. The driver-side seat belt cover may not be properly installed on the seat belt tensioner, which can cause the seat belt anchor to come loose.

High

NHTSAMay 2, 2025Nationwide• MERCEDES-BENZ

Licorice Plum (East CK Trading) – Undeclared Additives (2025)

Undeclared Allergen

Contains undeclared sulfites, undeclared FD&C Yellow 6, and unapproved color: Amaranth (E123).

Class IHigh

FDAMay 2, 2025NY, VA• East CK Trading Inc.

Testosterone Cypionate Injection (Empower Pharmacy) – Sterility Risk (2025)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 2, 2025Nationwide• Empower Clinic Services, LLC dba Empower Pharmacy

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