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Gambro Renal Products, Incorporated

Gambro Renal Products, Incorporated Recalls

All product recalls associated with Gambro Renal Products, Incorporated.

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Recall Summary

Total Recalls

1000

Past Year

1000

Class I (Serious)

127

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 18841–18860 of 25002 recalls

X-MARS Set (Gambro) – Connector Breakage (2014)

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Class IIModerate

FDAJul 18, 2014Nationwide• Gambro Renal Products, Incorporated

Prisma TPE 2000 set. Product number 109672. Each set is p... (Gambro Renal Products, Incorporated) – gambro initiated a field action on th... (2014)

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Class IIModerate

FDAJul 18, 2014Nationwide• Gambro Renal Products, Incorporated

Prisma M60 POSTDILUTION set. Product number 104183. Each ... (Gambro Renal Products, Incorporated) – gambro initiated a field action on th... (2014)

1...941 942943944 945...1251

Page 943 of 1251Next

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Class IIModerate

FDAJul 18, 2014Nationwide• Gambro Renal Products, Incorporated

Prisma M100 PRE pump infusion set. Product number 107791.... (Gambro Renal Products, Incorporated) – gambro initiated a field action on th... (2014)

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Class IIModerate

FDAJul 18, 2014Nationwide• Gambro Renal Products, Incorporated

Prismaflex M60 set. Product number 106696. Each set is pa... (Gambro Renal Products, Incorporated) – gambro initiated a field action on th... (2014)

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Class IIModerate

FDAJul 18, 2014Nationwide• Gambro Renal Products, Incorporated

Prisma M100 set. Product number 104182. Each set is packa... (Gambro Renal Products, Incorporated) – gambro initiated a field action on th... (2014)

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Class IIModerate

FDAJul 18, 2014Nationwide• Gambro Renal Products, Incorporated

Prisma M 100 PRE set. Product number 103657. Each set is ... (Gambro Renal Products, Incorporated) – gambro initiated a field action on th... (2014)

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Class IIModerate

FDAJul 18, 2014Nationwide• Gambro Renal Products, Incorporated

Prisma M 60 PRE set (new design). Product number 103658. ... (Gambro Renal Products, Incorporated) – gambro initiated a field action on th... (2014)

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Class IIModerate

FDAJul 18, 2014Nationwide• Gambro Renal Products, Incorporated

Prismaflex M100. Product number 106697. Each set is packa... (Gambro Renal Products, Incorporated) – gambro initiated a field action on th... (2014)

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Class IIModerate

FDAJul 18, 2014Nationwide• Gambro Renal Products, Incorporated

Prismaflex TPE 2000 set, Product Number 1071441. Each set... (Gambro Renal Products, Incorporated) – gambro initiated a field action on th... (2014)

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Class IIModerate

FDAJul 18, 2014Nationwide• Gambro Renal Products, Incorporated

Prismaflex M150. Product number 109990. Each set is packa... (Gambro Renal Products, Incorporated) – gambro initiated a field action on th... (2014)

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Class IIModerate

FDAJul 18, 2014Nationwide• Gambro Renal Products, Incorporated

Prismaflex HF 1000. Product number 107140. Each set is pa... (Gambro Renal Products, Incorporated) – gambro initiated a field action on th... (2014)

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Class IIModerate

FDAJul 18, 2014Nationwide• Gambro Renal Products, Incorporated

N-Acetyl Cysteine (Unique) – bacterial contamination (2014)

Non-Sterility: One lot of N-Acetyl Cysteine vials tested positive for Herbaspirillum huttiense.

FDAJul 18, 2014Nationwide• Unique Pharmaceutical, Ltd

Pluots (Wawona) – Potential Contamination (2014)

Certain lots of whole peaches (white and yellow), nectarines (white and yellow), plums and pluots packed between June 2 and July 12, 2014 may be contaminated with Listeria monocytogenes.

FDAJul 18, 2014Nationwide• Wawona Packing Company

Clonidine HCl Injection (X-Gen) – labeling error (2014)

Labeling: Label Error On Declared Strength: The side label description incorrectly states "Each mL contains 500 mcg Clonidine Hydrochloride" instead of stating "Each mL contains 100 mcg Clonidine Hydrochloride".

FDAJul 17, 2014Nationwide• X-Gen Pharmaceuticals Inc.

PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Ga... (Pentax Medical Company) – the instructions for use for the pent... (2014)

The Instructions for Use for the Pentax OF-B130 and OF-B194 Gas/Water Valve IFU if not followed carefully may cause a potential risk to health.

Class IIModerate

FDAJul 17, 2014CA, CO, ID +2 more• Pentax Medical Company

Children's Acetaminophen (Bio-pharm) – superpotent drug (2014)

Superpotent Drug: Bio-Pharm, Inc. is initiating a recall of one lot of Acetaminophen Oral Suspension Liquid 160mg/5mL failure of the product assay at the 6 month timepoint.

Class IIModerate

FDAJul 16, 2014Nationwide• Bio-pharm, Inc.

Daytrana Patch (Noven) – delivery system defect (2014)

Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration.

Class IIModerate

FDAJul 15, 2014Nationwide• Noven Pharmaceuticals, Inc.

2014 ASTON MARTIN DB9 – aston martin lagonda of north america... (2014)

Aston Martin Lagonda of North America (Aston Martin) is recalling certain model year 2014 DB9 and Rapide S vehicles manufactured June 2013 to July 2014. Due to a faulty circuit board, the transmissions in the affected vehicles may inadvertently shift to neutral without input from the driver.

NHTSAJul 14, 2014Nationwide• ASTON MARTIN

Panadol Advance (GSK) – Closure Failure (2014)

This recall involves bottles of 100ct Panadol Advance pain relievers. The medicine was sold in white containers with a blue label, inside a blue box. "Panadol" and "Advance" are printed on the label. Lot numbers and dates codes are located on the left side panel of the box and on the left side of the label on the bottle, near the bar code. Lot numbers and date codes included in the recall are: Lot number: 14241, expiration date: 02/2015 Lot number: 14002, expiration date: 10/2014 Lot number: 13881, expiration date: 09/2014 Lot number: 13801, expiration date: 09/2014

CPSCJul 14, 2014Nationwide• GlaxoSmithKline (GSK), of Moon Township, Penn.