Getinge Usa Sales Inc Recalls

Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tampering, or remote code execution via remote login to the Flow Anesthesia System, any of which could lead to a hazardous situation.

Flow-i C20 Anesthesia System (Getinge) – Cybersecurity Vulnerability (2023)

Flow-i C40 Anesthesia System (Getinge) – Cybersecurity Vulnerability (2023)

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Laceration Risk

High

FDADec 11, 2023Nationwide• Getinge Usa Sales Inc

Flow-e Anesthesia System (Getinge) – Cybersecurity Vulnerability (2023)

ENDOPATH Echelon Reloads (Ethicon) – Staple Line Formation Risk (2023)

There is the potential for incomplete staple line formation during the firing sequence, without most or all staples, which may lead to insufficient tissue apposition that could require surgical intervention. This may result in bleeding, prolonged surgery, or surgical delay.

FDADec 11, 2023Nationwide• Ethicon Endo-Surgery Inc

Flow-i C30 Anesthesia System (Getinge) – Cybersecurity Vulnerability (2023)

FDADec 8, 2023Nationwide• Olympus Corporation of the Americas

Duodenovideoscope Distal Cover (Olympus) – Detachment Risk (2023)

Fire/Burn Risk

Single Use Distal Cover MAJ-2315 may unexpectedly detach from the duodenoscope during use result include the risk of mucosal injury, tissue damage, bleeding, perforation, or obstruction due to retained distal cover in the gastrointestinal tract that would require urgent medical intervention for removal, and/or burns from the use an uncovered duodenoscope distal end. Detachment of a distal cover in the oral cavity may result in aspiration, airway obstruction, or respiratory distress and would require immediate medical intervention for removal.

Very High

XScribe Cardiac Stress System (Baxter) – ECG Reading Distortion (2023)

Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled.

FDADec 8, 2023Nationwide• Baxter Healthcare Corporation

Azurion FlexArm System (Philips) – Connectivity Loss (2023)

Loss of connectivity between the FlexArm and the Table due to a software issue.

FDADec 8, 2023Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

XScribe Cardiac Testing System (Baxter) – ECG Reading Distortion (2023)

Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled.

FDADec 8, 2023Nationwide• Baxter Healthcare Corporation

Forest River XLR Boost Trailer (Forest River) – Taillight Reflectivity (2023)

Forest River, Inc. (Forest River) is recalling certain 2024 XLR Boost toy haulers. The taillights may be insufficiently reflective. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 108, "Lamps, Reflective Devices, and Associated Equipment."

NHTSADec 8, 2023Nationwide• FOREST RIVER

Q-Stress Cardiac System (Baxter) – ECG Reading Distortion (2023)

Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled.

FDADec 8, 2023Nationwide• Baxter Healthcare Corporation

Eprontia Topiramate Solution (Azurity) – Impurity Specification (2023)

Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine stability testing at 18 months.

Class IIILow

FDADec 8, 2023Nationwide• Azurity Pharmaceuticals, Inc.

Christmas Petit Fours (Sweet Shop Candies) – Mold contamination (2023)

mold and yeast in product

Class IIModerate

FDADec 8, 2023AZ, CA, CO +15 more• Sweet Shop Candies, Inc

Incisive CT Scanner (Philips) – Cable Disconnection Risk (2023)

If the Patient Interface Monitor (PIM) Cable is plugged/unplugged frequently as part of daily operation, the connector and wire may disconnect from the welding point, which may result in intermittent loss of the ECG signal. Loss of ECG signal may lead to the decision to rescan the patient or delay in diagnosis during a clinical emergency.

FDADec 7, 2023AL, CA, CO +25 more• Philips North America

Pepper Gel Spray (Security Equipment) – Operational failure (2023)

Fire/Burn Risk

This recall involves SABRE Aim & Fire Pepper Gel with Training Canisters with model number SDP-G-03. The canisters look like a toy gun and have a black handle with an orange body. Only units with the expiration date of 9/2027 are included in the recall. The expiration date can be found on the white label on the side of the canisters.

CPSCDec 7, 2023Nationwide• Security Equipment Corporation, of Fenton, Missouri

Dutchmen Coleman (Dutchmen) – Front Suspension Axle Risk (2023)

Keystone RV Company (Keystone) is recalling certain 2021-2022 Dutchmen Coleman 1855RB and 190BH travel trailers. The trailers may be equipped with axle springs rated at 4400 pounds instead of 5100 pounds.

NHTSADec 7, 2023Nationwide• DUTCHMEN

Altec Aerial Device (Altec) – Welder Track System (2023)

Altec Industries, Inc. (Altec) is recalling certain 2021-2023 CB5-132D-S vehicles equipped with a Bobcat 260 welder installed on a track system. The welder may be misaligned, preventing the mounting fasteners from being properly tightened.

NHTSADec 7, 2023Nationwide• ALTEC

Fugleman Utility Vehicles (Segway) – Fire hazard (2023)

Fire/Burn Risk

This recall involves model year 2022 Fugleman Utility -Terrain Vehicles (UTVs) with model numbers UT10E or UT10X. These vehicles were sold in various colors including white, black, gray and camo. "FUGLEMAN" decals are printed on the right and left rear side panels. The Segway logo is on the hood. The model number is located on the right and left rear side panels next to the Fugleman logo.