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Fresenius Medical Care North America

Fresenius Medical Care North America Recalls

All product recalls associated with Fresenius Medical Care North America.

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Recall Summary

Total Recalls

1000

Past Year

893

Class I (Serious)

124

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 15201–15220 of 17593 recalls

Fresenius Medical Care North America: CombiSet True Flow Series, Hemodialysis Blood Tubing with...

Port may crack and separate resulting in potential blood exposure/blood loss for the patient

FDANov 25, 2008Nationwide• Fresenius Medical Care North America

Philips Medical Systems (Cleveland) Inc: Respiratory Gating System, Catalog #NPTA540, Model #4535 ...

A leak between the Tube Interface and the Outlet Tube of the transducer for the Respiratory Gating System component may result in a failure of the device to produce respiratory correlated images.

FDANov 24, 2008PR• Philips Medical Systems (Cleveland) Inc

Becton Dickinson & Company: BD 1 ml Integra TB Syringe with Retracting Precision Glid...

Expiry date on the shelf carton is incorrect. It reads 2013-13, it should read 2013-03.

FDA

1...759 760761762 763...880

Page 761 of 880Next

Nov 24, 2008

FL, GA, KS +5 more

• Becton Dickinson & Company

Varian Medical Systems Oncology Systems: Varian Medical Systems Eclipse treatment planning system,...

Possible incorrect wedge orientation in treatment: Software labeling was issued without warning message relating to preservation of user selected values for Siemens wedge orientation, wedge limits and SAD values for Elekta machines, and collimator operating limits for Saturne Machines when the software version is upgraded.

FDANov 21, 2008Nationwide• Varian Medical Systems Oncology Systems

Philips Medical Systems North America Co. Phillips: The device's marketing brochure states: "IntelliVue M3150...

Potential for Internal Sound Amplifier to malfunction which could delay treatment.

FDANov 21, 2008Nationwide• Philips Medical Systems North America Co. Phillips

GE Medical Systems, LLC: Innova 2121-IQ/3131-IQ Biplane Cardiovascular Imaging Sys...

GE Healthcare has become aware of a potential image storage failure on Innova 2121 IQ/ 3131 IQ cardiovascular imaging systems that may impact patient safety. This intermittent communication failure on the image storage chain may result in the following situations: Record abort, Record not available, Fluorostore function not available, Review not available, Boot/Reset failure. Fluoroscopy imag

FDANov 21, 2008CA, CO, FL +19 more• GE Medical Systems, LLC

Medtronic Xomed, Inc.: VARI-STIM III Nerve Locator/Stimulator, Sterile, Medtroni...

Device may fail to operate or operate intermittently during use and such operation could result in a lack of nerve stimulation when nerve tissue is actually contacted by the stimulator.

FDANov 21, 2008Nationwide• Medtronic Xomed, Inc.

Smiths Medical MD, Inc.: Deltec Cozmo Insulin Pump, Model 1800. Deltec Cozmo Ins...

Smiths Medical has become aware of a display irregularity with the Deltec Cozmo Insulin Pump, Model 1800 and Model 21-1700 containing Model 1800 software. There have been adverse events reported that the amount of Extended Bolus delivered was not accurately displayed by the Pump. The amount of extended Bolus displayed on the Pump Home Screen 2 and in the Bolus Summary Report is less than what w

FDANov 20, 2008AL, AK, AZ +48 more• Smiths Medical MD, Inc.

DiNotte Bicycle Light Batteries – Burn Hazard (2008)

Fire/Burn Risk

DiNotte Lighting Lithium-Ion battery with nylon bags are used with DiNotte 5W Li-Ion bicycle lights and DiNotte 3 LED police lights. The DiNotte logo is printed on the battery cable connector.

CPSCNov 18, 2008Nationwide• AA Portable Power Corp., of Richmond, Calif.

GE Wall Ovens – Fire and Burn Risk (2008)

Fire/Burn Risk

This recall involves GE wall ovens sold under the following brand names: GE®, GE Profile™, Monogram® and Kenmore®. The wall ovens were sold in white, black, bisque and stainless steel. The following model and serial numbers can be found inside the oven on the left interior wall. For microwave combination ovens, the serial number can be found on the left interior wall of the microwave. Brand Model Serial Number Begins With GE/Profile JCT915, JT912, JT915, JT952, JT955, JT965, JT980*, JTP20, JTP25, JTP28, JTP48, JTP50, JTP86 TD, VD, ZD AF, DF, FF, GF, HF, LF, MF, RF, SF, TF, VF, ZF Monogram ZET3058, ZET938, ZET958 Kenmore (All model numbers start with 911) 4771, 4775, 4781, 4904, 4905, 4923* 2T, 2V, 2Z 3A, 3D, 3F, 3G, 3H, 3L, 3M, 3R, 3S, 3T, 3V, 3Z * Lower oven only

CPSCNov 18, 2008Nationwide• GE Consumer & Industrial, of Louisville, Ky.

Stryker Communications Corp: Vertier Surgical Table, an AC powered, general purpose, m...

Surgical tables were produced using an unapproved tilt frame bushing.

FDANov 13, 2008Nationwide• Stryker Communications Corp

Off-Road Competition Motorcycles (Honda) – Weld Failure Risk (2008)

This recall involves model year 2007-2008 Honda CRF150R/RB motocross competition motorcycles.

CPSCNov 13, 2008Nationwide• American Honda Motor Co. Inc., of Torrance, Calif.

BD Diagnostics (GeneOhm Sciences, Inc): BD Diagnostics, BD GeneOhm MRSA Assay, REF: 441242 (200 R...

BD Diagnostics GeneOhm (BDDG) has determined that the Cepheid SmartCycler reaction tubes packaged in the BD GeneOhm MRSA test kits identified above may be defective.

FDANov 11, 2008CA, IL, IN +15 more• BD Diagnostics (GeneOhm Sciences, Inc)

Acist Medical Systems: ACIST CVi Angiographic Injection System with Interface Ca...

Multiple Injections may result. It has been determined that when using the ACIST CVi Angiographic Injection system to synchronize with the Toshiba Infinix -i cardiovascular x-ray system there is an injection scenario that may result in multiple injections of contract media when one injection was intended.

FDANov 10, 2008AZ, AR, FL +1 more• Acist Medical Systems

Merit Medical Systems, Inc.: ReSolve Hydrophilic Coated Locking Biliary Catheter, REF ...

Biliary drainage catheter tips may separate from the catheter shaft after placement.

FDANov 7, 2008Nationwide• Merit Medical Systems, Inc.

Merit Medical Systems, Inc.: ReSolve Hydophilic Coated Locking Biliary Catheter, REF R...

Biliary drainage catheter tips may separate from the catheter shaft after placement.

FDANov 7, 2008Nationwide• Merit Medical Systems, Inc.

Terumo Cardiovascular Systems Corporation: Terumo Advanced Perfusion System 1; 100V -120V, 15 A (cir...

The power manager board may cause a short circuit, resulting in loss of system power, loss of central control monitor or electrical arcing.

FDANov 7, 2008Nationwide• Terumo Cardiovascular Systems Corporation

Leica Microsystems, Inc.: QCA and iQCA software, a video microscopy software system...

A change in the software to open up the software architecture to include other analytes other than Estrogen Receptor was made without FDA review and approval.

FDANov 6, 2008Nationwide• Leica Microsystems, Inc.

Hitachi Medical Systems America Inc: Hitachi CXR4 Computed Tomography Scanner. This product is...

Software error: The device has a software error that can result in a condition where the displayed image orientation does not match the display orientation markers (right-left reversal).

FDANov 5, 2008Nationwide• Hitachi Medical Systems America Inc

GE Medical Systems, LLC: GE Innova 4100/4100 IQ. , GE Healthcare, Waukesha, WI 531...

One of three copper spectral filters could remain within the x-ray while the system displays no spectral filter. The displayed Air Kerma rate and thus cumulative Air Kerma are overestimated. The Air Kerma rate may be over estimated by up to 60%.

FDANov 4, 2008Nationwide• GE Medical Systems, LLC