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Maquet Medical Systems USA

Maquet Medical Systems USA Recalls

All product recalls associated with Maquet Medical Systems USA.

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Recall Summary

Total Recalls

1000

Past Year

583

Class I (Serious)

Most Recent

Dec 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1221–1240 of 10937 recalls

Bubble Sensor (Maquet) – UDI Identifier Problem (2023)

The Bubble Sensor optional accessory to the CARDIOHELP-i extracorporeal life support system includes an incorrect UDI Device Identifier (DI) provided with the label attached to the device.

FDADec 28, 2023AZ, CA, CO +10 more• Maquet Medical Systems USA

Senographe Pristina (GE Medical Systems) – x-ray signal issue (2023)

X-ray exposure termination audible signal on Senographe Pristina with Efficiency Suite 2 intermittently not emitted per 21CFR 1020.31(j) requirements.

FDADec 26, 2023Nationwide• GE Medical Systems, SCS

Melissa's Hot Kimchi (World Variety) – undeclared fish (2023)

Undeclared Allergen

Undeclared allergen; fish.

Class IHigh

1...60 616263 64...547

Page 62 of 547Next

FDA

Dec 22, 2023

CA, FL, TX

• World Variety Produce Inc dba Melissa's

Henry Schein Masks (AMD Medicom) – production equipment problem (2023)

Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.

FDADec 21, 2023Nationwide• AMD Medicom Inc. 2555 Ch de L'Aviation Montreal Canada

Henry Schein Masks (AMD Medicom) – production equipment problem (2023)

Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.

FDADec 21, 2023Nationwide• AMD Medicom Inc. 2555 Ch de L'Aviation Montreal Canada

Patterson Procedure Masks (AMD Medicom) – production equipment problem (2023)

Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.

FDADec 21, 2023Nationwide• AMD Medicom Inc. 2555 Ch de L'Aviation Montreal Canada

Americaine Benzocaine Spray (Insight) – Benzene Contamination (2023)

Chemical Contamination: presence of benzene

Class IHigh

FDADec 21, 2023Nationwide• Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company

FLEXSelect Latex Elastics (G & H Wire) – mislabeling risk (2023)

Latex elastic bands were labeled as non-latex elastic bands, an allergic rx can occur due to patient latex allergy

FDADec 21, 2023Nationwide• G & H Wire Company

Intellis Programmer (Medtronic) – Session Establishment Issue (2023)

Medtronic has discovered an instance in which the Intellis A710 Clinician Programmer Application (CP App) could no longer establish a session with the Implantable Neurostimulator (INS) which resulted in the inability for the clinician to adjust stimulation parameters. In the event of this issue, the patient may receive inadequate or excessive therapy and experience non-optimal pain relief.

FDADec 19, 2023Nationwide• Medtronic Neuromodulation

Member's Mark Cheddar (Biery Cheese) - Foreign Material (2023)

Foreign Material - Glove remnants

Class IIModerate

FDADec 18, 2023IL, IN, MO +1 more• Biery Cheese Company

Ranger XP Kinetic ROVs (Polaris) – Crash Risk (2023)

This recall involves Model Year 2023-2024 RANGER XP Kinetic vehicles. The vehicles were sold in the following colors: camouflage and white. They were sold in three-seat configurations and have "POLARIS" stamped on the front grille. The model number and VIN are printed on a portion of the left rear frame (on the driver's side of the vehicle) under the cargo box.

CPSCDec 14, 2023Nationwide• Polaris Industries Inc., of Medina, Minnesota

Can-Am Side-By-Side Vehicles (BRP) – Injury Hazard (2023)

This recall involves Model Year 2022 and 2023 Can-Am Commander series, Defender series, Maverick Trail series equipped with an HD7 or 700 engines side-by-side vehicles with model number model year 2022 and 2023. The vehicles were sold in various colors. The brand and model name are on the vehicle's sides.

CPSCDec 14, 2023Nationwide• BRP Mexico, of Mexico

Spectral CT on Rails (Philips) – Image Labeling Error (2023)

A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment.

FDADec 13, 2023Nationwide• PHILIPS MEDICAL SYSTEMS

Spectral CT 7500 (Philips) – Image Labeling Error (2023)

A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment.

FDADec 13, 2023Nationwide• PHILIPS MEDICAL SYSTEMS

Azurion System (Philips) – Imaging Functionality Loss (2023)

System may exhibit a loss of imaging functionality and data due to an issue which can cause the system to continuously restart. If the issue occurs during a procedure, there may be a delay and/or abortion of the procedure.

FDADec 12, 2023Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

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

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

CYF-VHR Videoscope (Olympus) – Cleaning Brush Update (2023)

Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.

FDADec 4, 2023Nationwide• Shirakawa Olympus Co., Ltd. Azaokamiyama 3-1 Oazaodakura; Nishigo-Mura Nishishirakawa-Gun Japan

CYF-5 Cystonephrofiberscope (Olympus) – Cleaning Brush Update (2023)

Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.

FDADec 4, 2023Nationwide• Shirakawa Olympus Co., Ltd. Azaokamiyama 3-1 Oazaodakura; Nishigo-Mura Nishishirakawa-Gun Japan

ENF-XP Rhino-Laryngofiberscope (Olympus) – Cleaning Brush Update (2023)

Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.

FDADec 4, 2023Nationwide• Shirakawa Olympus Co., Ltd. Azaokamiyama 3-1 Oazaodakura; Nishigo-Mura Nishishirakawa-Gun Japan