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Fresenius Medical Care Holdings, Inc.

Fresenius Medical Care Holdings, Inc. Recalls

All product recalls associated with Fresenius Medical Care Holdings, Inc..

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Recall Summary

Total Recalls

1000

Past Year

Class I (Serious)

Most Recent

Nov 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 861–880 of 2399 recalls

Fresenius Medical Care Holdings, Inc.: Fresenius 2008T BlueStar Hemodialysis Machine Part Num...

A "Remove USB Device 2" false alarm may be displayed when no USB device or a non-powered USB device is connected to the USB port on the rear of the machine

FDAMar 12, 2020Nationwide• Fresenius Medical Care Holdings, Inc.

Fresenius Medical Care Holdings, Inc.: Fresenius 2008T Hemodialysis Machine: Part Number Descri...

A "Remove USB Device 2" false alarm may be displayed when no USB device or a non-powered USB device is connected to the USB port on the rear of the machine

FDAMar 12, 2020Nationwide• Fresenius Medical Care Holdings, Inc.

Pantoprazole Tablets (Jubilant Cadista) – tablet discoloration (2020)

CGMP Deviations: Presence of dark brown discoloration on edges of tablets

Class II

1...42 434445 46...120

Page 44 of 120Next

Moderate

FDAMar 11, 2020Nationwide• Jubilant Cadista Pharmaceuticals, Inc.

Northgate Technologies, Inc.: Probe, 9 FR AUTOLITH; NTI Catalog Number 9-900-54 - Produ...

As part of an investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.

FDAMar 10, 2020Nationwide• Northgate Technologies, Inc.

Northgate Technologies, Inc.: ACMI 9FR PROBE (E4-9F) Manufactured for Olympus Surgical ...

Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.

FDAMar 10, 2020Nationwide• Northgate Technologies, Inc.

Northgate Technologies, Inc.: AUTOLITH URO-TCH 9FR PROBE 54CM; NTI Catalog Number 9-203...

Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.

FDAMar 10, 2020Nationwide• Northgate Technologies, Inc.

Sodium Chloride Injection (Fresenius) – Sterilization Issue (2020)

CGMP Deviation: Chemical indicators were not positioned properly during sterilization process.

Class IIModerate

FDAMar 5, 2020Nationwide• Fresenius Medical Care Holdings, Inc.

Merits Holdings Co. dba Merits Health Products, Inc.: Merits E604 Pilot Navigator Stairlift - Product Usage: To...

Pinion gear may disengage from track allowing lift to slip or jolt.

FDAMar 2, 2020Nationwide• Merits Holdings Co. dba Merits Health Products, Inc.

Raisins (Caruthers Raisin) – foreign material processing (2020)

Laser on processing line found foreign material during the processing of raisins.

Class IIModerate

FDAFeb 21, 2020AZ, CA, CT +7 more• Caruthers Raisin Packing Co., Inc.

Micro Therapeutics Inc, Dba Ev3 Neurovascular: ev3 Pipeline Flex Embolization Device. For neurological ...

Embolization device delivery system may fracture at the distal section during device implantation. A weakened bond may result in unintended separation, where the distal portion of the device delivery system remains in the patient. If a Pipeline Flex embolization device has already been implanted successfully, there is no increased risk to patients due to this issue.

FDAFeb 14, 2020Nationwide• Micro Therapeutics Inc, Dba Ev3 Neurovascular

Coburn Farms Snackers Cheddar (Great Lakes) – Undeclared Peanut (2020)

Fire/Burn Risk

Coburn Farms 4.5oz Snackers is being recalled due to a labeling error leading to undeclared peanut.

Class IIModerate

FDAFeb 12, 2020FL, IL, IN +11 more• Great Lakes Cheese Co Inc

Roche Diagnostics Operations, Inc.: Elecsys CA 19-9, Cat. No. 07027028190 - Product Usage: th...

The firm has received an increased number of complaints concerning non-reproducible elevated results ("high flyers") for one lot of Elecsys CA 19-9 reagent, which may affect clinical interpretation.

FDAFeb 7, 2020Nationwide• Roche Diagnostics Operations, Inc.

Walk Behind Leaf Blowers (DR Power) – Projectile hazard (2020)

This recall involves DR Walk Behind Leaf Blowers, including DR PREMIER 1200, DR PRO 2000 and DR PRO 2000SP. The blowers are three-wheeled walk behind blowers with an orange circular metal face with a black center with "DR" printed on the front. The model number is printed on the front left side of the main impeller housing and on the serial number label located on the back right side of the main impeller housing. Only the following models are included in the recall: Product name Model Number DR PREMIER 1200 Walk Behind Leaf Blower WB13010DMN DR PRO 2000 Walk Behind Leaf Blower WB15020DMN DR PRO 2000 Walk Behind Leaf Blower WB15020DEN DR PRO 2000SP Walk Behind Leaf Blower WB17020DEN

CPSCFeb 6, 2020Nationwide• Country Home Products Inc., d/b/a DR Power Equipment, of South Burlington, Vt.

Hitachi Medical Systems America Inc: UST-2265-2 Probe, Part Number: UST-2265-2 - Product Usage...

These 18 probes may have mis-wiring in the inner cables, causing decreased sensitivity and thus resulting in lower peak velocity readings.

FDAJan 31, 2020CA, FL, GA +5 more• Hitachi Medical Systems America Inc

Fresenius Medical Care Holdings, Inc.: Honeywell Pressure Transducer- Part Number: 370506-22. It...

The firm is replacing pressure transducers with an improved design due to an increase in customer complaints regarding lower long-term reliability of the part.

FDAJan 29, 2020Nationwide• Fresenius Medical Care Holdings, Inc.

Clonidine Tablets (Unichem) – Benzophenone Migration (2020)

Failed Impurities/Degredation Specifications: This recall is initiated as a precautionary measure due to potential migration of Benzophenone at very low level into product from container label.

Class IIILow

FDAJan 29, 2020Nationwide• UNICHEM PHARMACEUTICALS USA INC

Pioglitazone Metformin Tablets (Macleods) – Subpotent Drug (2020)

Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metformin Hydrochloride Tablets.

Class IIILow

FDAJan 24, 2020Nationwide• Macleods Pharma Usa Inc

Polymer Technology Systems, Inc.: PTS Detect Cotinine, Ref. No. 3061, UPC 381933061017 in v...

The firm is removing the product from the market after discussions with the FDA due to lack of 510(k) clearance.

FDAJan 21, 2020Nationwide• Polymer Technology Systems, Inc.

Montelukast Sodium Tablets (Macleods) – Failed Dissolution (2020)

Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product

Class IIILow

FDAJan 20, 2020Nationwide• Macleods Pharma Usa Inc

Roche Diagnostics Operations, Inc.: cobas infinity core, Material No. 7154003001. The device ...

Alarm flags that have a "<" symbol in front of them are not displayed on the cobas infinity Validation screen. This issue affects only customers that are doing manual validation on the cobas infinity Validation screen.

FDAJan 7, 2020AL, AK, CA +17 more• Roche Diagnostics Operations, Inc.