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Atrium Medical Corporation

Atrium Medical Corporation Recalls

All product recalls associated with Atrium Medical Corporation.

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Recall Summary

Total Recalls

1000

Past Year

1000

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 3381–3400 of 21320 recalls

Express Dry Seal Chest Drains (Atrium) – Setup Instructions (2023)

Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube connections with single collection chamber chest drains

Moderate

FDASep 18, 2023Nationwide• Atrium Medical Corporation

Nova Prime Plus Analyzer (Nova Biomedical) – Creatinine Results (2023)

Potential risk of reporting erroneous creatinine patient results associated with the initial start-up of a new BUN/Creatinine Sensor Cartridge. The potential risk is within the first 2-4 hours after cartridge installation that may not be identified by traditional Quality Control practices.

Moderate

FDASep 18, 2023Nationwide• Nova Biomedical Corporation

Oasis Dry Suction Chest Drains (Atrium) – Setup Instructions (2023)

1...168 169170171 172...1066

Page 170 of 1066Next

Moderate

FDASep 18, 2023Nationwide• Atrium Medical Corporation

Senhance Surgical System (Asensus) – Malfunction Risk (2023)

Asensus Surgical has identified a malfunction that has occurred and may recur on the Senhance Surgical System. This issue presented itself as uncontrolled arm motion of the Laparoscope Instrument Actuator (LIA) where the LIA rotated continuously in one direction after the Surgeon removed the engagement of teleoperation on the Senhance System. There was no other uncontrolled arm motion observed.

Moderate

FDASep 15, 2023FL, IL, LA +2 more• Asensus Surgical Inc

EVIS EXERA III Video System (Olympus) – Power Supply Issue (2023)

Certain serial numbers of the CV-190 do not start up properly because parts that deviated from the specification were assembled into the power supply unit.

Moderate

FDASep 14, 2023Nationwide• Olympus Corporation of the Americas

Aptima CMV Quant Assay (Hologic) – Sample Error (2023)

Use of assay along with plasma specimen may result in error code which would invalidate sample.

Low

FDASep 14, 2023Nationwide• Hologic, Inc.

BACTEC Culture Vials (Becton Dickinson) – Barcode Duplication (2023)

Certain vials of the BD BACTEC" Plus Aerobic/F Culture Vials have a labeling issue where duplicate barcode sequence numbers have been identified on more than one vial.

High

FDASep 12, 2023Nationwide• Becton Dickinson & Co.

Cios Alpha C-arm (Siemens) – Software Update (2023)

Software issue for Cios Alpha, Cios Flow, and Cios Spin VA30 systems, fulfillment of new requirements from DIN and IEC standards for Cios VA30 systems required may result in patient misdiagnosis/repeat exposure

High

FDASep 12, 2023Nationwide• Siemens Medical Solutions USA, Inc

Thunderbeat Surgical Device (Olympus) – Button Malfunction (2023)

Thunderbeats blue seal button may remain in the engaged position after the button is released and not immediately return to a neutral position may result in prolonged surgery

Moderate

FDASep 12, 2023Nationwide• Olympus Corporation of the Americas

VITROS Lipase Slides (Ortho-Clinical) – Result Bias (2023)

Laceration Risk

Products 1668409 and 8297749 may contain VITROS Lipase Slides with an abnormality which could cause -46% to +86% bias in lipase results depending on how the slides are used. Falsely low levels could result in a missed or delayed diagnosis of acute pancreatitis and may lead to diagnostic confusion in the setting of acute abdominal symptoms. Falsely elevated levels would not result in patient harm but may cause diagnostic confusion and a delay in accurate diagnosis of a patient with abdominal pain.

High

FDASep 12, 2023CA, CO, FL +9 more• Ortho-Clinical Diagnostics, INc.

Cios Flow C-arm (Siemens) – Software Update (2023)

High

FDASep 12, 2023Nationwide• Siemens Medical Solutions USA, Inc

Thunderbeat Surgical Device (Olympus) – Button Malfunction (2023)

Thunderbeats blue seal button may remain in the engaged position after the button is released and not immediately return to a neutral position may result in prolonged surgery

Moderate

FDASep 12, 2023Nationwide• Olympus Corporation of the Americas

Homestyle Hamburger Buns (Knickerbocker) – Undeclared Milk (2023)

Undeclared Milk

Undeclared milk

Class IHigh

FDASep 12, 2023IN, MI• Knickerbocker 365 Inc.

Sapphire Infusion Pumps (Eitan Medical) – Air Detection Failure (2023)

Infusion Pumps with affected software revision may fail to detect air in line, which may lead to air embolism.

Very High

FDASep 11, 2023Nationwide• EITAN MEDICAL LTD 29, Yad Kharutsim Netanya Israel

Omega Monitor Suspension (Omega Medical) – Boom Detachment (2023)

An actuator separated from the pivot mechanism on a lower monitor boom system column. The lower boom became detached at the point shown and was restrained by the installed safety cable.

Moderate

FDASep 8, 2023AL, CA, IL +8 more• Omega Medical Imaging, Inc.

F2-01 Patient Monitor (GE Medical) – Data Communication Interruption (2023)

There is a potential interruption of data communication between E-modules inserted in the F2-01 Frame and CARESCAPE ONE and CARESCAPE Canvas 1000 patient monitors if the F2-01 Frame has not been powered down within the last 120 days.

Moderate

FDASep 8, 2023Nationwide• GE Medical Systems China Co., Ltd. National Hi-Tech No.

Sandimmune Oral Solution (Novartis) – Crystallization Issue (2023)

Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.

Class IHigh

FDASep 8, 2023Nationwide• Novartis Pharmaceuticals Corp.

Commercial Clothes Dryers (Whirlpool) – Fire hazard (2023)

Fire/Burn Risk

This recall involves all ADC brand stacked commercial clothes dryers with a 30 lb. capacity and model number ADG-30X2R or ADG-30X2Ri. Both models were sold in on-premise and coin-operated configurations for multi-unit housing, laundromats, and other facilities that use commercial laundry equipment. Logos and branding may appear differently depending on when the unit was manufactured. The model number for each unit is printed inside near the hinges of the upper door. The ADG-30X2R units were also sold in custom colors other than white to fit location branding.

High

CPSCSep 7, 2023Nationwide• Whirlpool Corporation, of Benton Harbor, Michigan

Cequa Eye Solution (Sun Pharmaceutical) – Subpotent Medication (2023)

Subpotent: Out of Specification result observed for low assay

Class IIILow

FDASep 7, 2023Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Hemodialysis System (Fresenius) – Tubing Leaching (2023)

Potential PCBA leaching from tubing of hemodialysis machines.

Low

FDASep 6, 2023Nationwide• Fresenius Medical Care Holdings, Inc.