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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

353

Class I (Serious)

Most Recent

Jan 2026

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 721–740 of 3680 recalls

CARDIOHELP-i System (Maquet) – Leakage Current Test (2023)

CARDIOHELP-i System was not properly tested to measure leakage current

Low

FDANov 14, 2023Nationwide• Maquet Medical Systems USA

Hookup Accessories (Steris) – Label Illegibility (2023)

Identification label on affected hookups could become illegible over time due to the label's ink coming off. This may potentially prevent users from being able to effectively identify the hookup and may ultimately result in postponement of patient procedures.

Low

FDANov 13, 2023Nationwide• Steris Corporation

Venous Probe Cable (Maquet) – Insulation Breaks (2023)

Firm received complaints of breaks in the insulation, shielding, or wires of the venous probe connection cable. Fracture of the venous probe cable may influence the management of extracorporeal support. Patient may be exposed to inappropriate blood flow, blood temperature, or hematocrit/hemoglobin levels as a result of the CARDIOHELP-i not receiving information from the venous probe.

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High

FDANov 13, 2023Nationwide• Maquet Medical Systems USA

Tow-Behind Field Mowers (DR Power) – fire hazard (2023)

Fire/Burn Risk

This recall involves DR Power Equipment and Generac brand tow-behind field and brush mowers. The following model and serial numbers, printed on a white label that is on the rear frame of the mower near the right rear tire, are included in this recall. Name Model Number Serial Number Range DR Power Tow-Behind Field and Brush Mower TB 25044B EN All serial numbers beginning with TB2, plus 3002188267 to 30024310751 TB 25044B ENC 30030052232 to 3004525033 TB 25044B ENR 3004734233, 3004835965, 3005064288, 3005471720, 3005548665, 3007678624, 3008122643 TBM 20A ED TDVE OF1 All serial numbers beginning with TB; in addition, 300275210 TBM 20A EN TDVE OD3 All TBM 20A EN TDVE OF3 TBM20AENTDVEOF3 All 3002188263 to 3002490281 Generac Tow-Behind Field and Brush Mower TB 25044GENG 3003540054 to 3004428691

High

CPSCNov 9, 2023Nationwide• DR Power Equipment, of South Burlington, Vermont, a subsidiary of Generac Power Systems Inc., of Waukesha, Wisconsin (through January 2018)

Medical System (GE) – Bolt Torque Issue (2023)

GE HealthCare has become aware of the potential that incorrect torque has been applied to certain bolts of the Definium Tempo and Definium Tempo Pro products which may result in a potential fall of elements of the Overhead Tube Suspension (OTS) assembly.

High

FDANov 7, 2023Nationwide• GE Hangwei Medical Systems, Co. LTD West Area Bldg. 3, No.1 Yongchang North Road 1 Yongchangbeilu; Beijing Economic and Technological Development Area Beijing China

CARDIOHELP-i System (Maquet) – Factory Settings (2023)

Certain factory settings for the device were incorrectly described in the IFU-related to the warning limits for PVen and PAux, and the default settings for the venous bubble sensor (VBS) and the automatic lock in the Minimized Extracorporeal Circulation (MECC) ThApp

Moderate

FDANov 6, 2023Nationwide• Maquet Medical Systems USA

Fountain Microcatheter (Merit Medical) – sterility risk (2023)

The sterility of microcatheter and infusion system devices cannot be guaranteed.

Very High

FDANov 6, 2023Nationwide• Merit Medical Systems, Inc.

Merit Pursue Microcatheter (Merit Medical) – sterility risk (2023)

The sterility of microcatheter and infusion system devices cannot be guaranteed.

Very High

FDANov 6, 2023Nationwide• Merit Medical Systems, Inc.

Merit Maestro Microcatheter (Merit Medical) – sterility risk (2023)

The sterility of microcatheter and infusion system devices cannot be guaranteed.

Moderate

FDANov 6, 2023Nationwide• Merit Medical Systems, Inc.

Allura Systems (Philips) – ceiling mount collision risk (2023)

Ceiling mounted L-arm contains a rotation cover that may potentially be susceptible to falling if a collision between the L-arm and other hospital equipment (i.e., an operating light) were to occur result in injury or potential sterility issues due to the cover becoming loose

Moderate

FDANov 3, 2023Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Azurion Systems (Philips) – ceiling mount collision risk (2023)

Moderate

FDANov 3, 2023Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Unity Total Knee System (Corin) – mislabeling risk (2023)

Potential for Unity CR Inserts Right size 6 from batch 529803 to be incorrectly labelled as Unity CR Inserts Right size 7 from batch 532405 and visa versa.

Low

FDAOct 13, 2023IL, MI, TX• Corin Ltd Unit 1-57-8 Corinium Centre Cirencester United Kingdom

Unity CR Femur (Corin) – mislabeling risk (2023)

Potential for Unity CR Inserts Right size 6 from batch 529803 to be incorrectly labelled as Unity CR Inserts Right size 7 from batch 532405 and visa versa.

Low

FDAOct 13, 2023IL, MI, TX• Corin Ltd Unit 1-57-8 Corinium Centre Cirencester United Kingdom

Cardiohelp-i System (Maquet) – weld defect (2023)

It was found that the fixation (weld) employed by the supplier of the nut bolt to the slide rail plate was insufficient. The deficient weld allows the nut bolt to break off from the slide rail plate with slight manual force.

High

FDAOct 12, 2023Nationwide• Maquet Medical Systems USA

CARDIOHELP Emergency Drive (Maquet) – Patient Exposure Risk (2023)

Product removal due to possible blocking or impairment of the CARDIOHELP Emergency Drive. This issue can lead to the patient being exposed to inappropriate low blood flow. Potential associated harms are ischemia and hypoxia.

High

FDAOct 10, 2023Nationwide• Maquet Medical Systems USA

Lobster Meat (Greenhead) – Listeria Contamination (2023)

Listeria

Lobster meat may be contaminated with Listeria monocytogenes.

Class IHigh

FDAOct 9, 2023AL, AZ, CA +25 more• Greenhead Lobster Products LLC

ORION System (LEONI) – Unintended Movement Risk (2023)

Users of the patient positioning system ORION System can be faced with a sudden short-term acceleration or with an unintended short-distance movement when the movements are again allowed after an unforeseen interruption signal of motion may result in a collision of the patient with another stationary component of the treatment room.

High

FDAOct 6, 2023Nationwide• LEONI CIA CABLE SYSTEMS 5 avenue Victor Hugo Chartres France

BD Insyte IV Catheter (Becton Dickinson) – Needle Retraction Issue (2023)

Over-the-needle, intravascular catheters may have needles that do not retract properly into the barrel, which could result in contaminated needlestick injury, blood leaking from the insertion site or catheter, and repeat catheter insertion attempts, due to catheter being inadvertently removed from the insertion site.

High

FDAOct 4, 2023Nationwide• Becton Dickinson Infusion Therapy Systems Inc.

DR Power Chipper Shredders (Generac) – Laceration Hazard (2023)

Laceration Risk

This recall involves DR Power Equipment Chipper Shredders with model numbers CS35050BEN, CS35050BENR, CS35050BENSD, CS35150BEN, CS35150BENR, CS35150BENSD, CS35150DEN, CS45040DMN, CS45040DEN, CS45040DENR, CS45040DMNR, CS43030DMN and CS43030DMNR. For model numbers beginning CS3, the model number is on the side of the unit. For model numbers beginning CS4, the model and serial numbers are printed on a white label located on the base of the machine to the left of the engine manual start handle. The chippers were sold in orange and black with a funnel at the top to shred brush.

High

CPSCSep 21, 2023Nationwide• Generac Power Systems Inc., of Waukesha, Wisconsin

Organic Jasmine Rice (Good & Gather) – Insect Contamination (2023)

Insects (rice weevils) found in bags of rice.

Class IIILow

FDASep 21, 2023Nationwide• Otis McAllister