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SCA Pharmaceuticals

SCA Pharmaceuticals Recalls

All product recalls associated with SCA Pharmaceuticals.

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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 3661–3680 of 21320 recalls

Fentanyl-Bupivacaine Solution (SCA Pharma) – Rejected Units Shipped (2023)

cGMP deviations: due to shipment of rejected units.

Class IIModerate

FDAJul 20, 2023KY, NJ• SCA Pharmaceuticals

Zenition 70 (Philips) – Radiation Exposure Risk (2023)

Philips has become aware of the potential for unintended radiation exposure with Zenition 70 systems with Vascular Extension option and a Wireless Foot Switch.

Moderate

FDAJul 20, 2023Nationwide• Philips Medical Systems Nederland B.V. High Tech Campus 36 Eindhoven Netherlands

Azurion (Philips) – Unintended Radiation Emission (2023)

A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation

Moderate

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FDA

Jul 19, 2023

Nationwide

• Philips Medical Systems Nederland B.V. High Tech Campus 36 Eindhoven Netherlands

Allura Xper Series (Philips) – Unintended Radiation Emission (2023)

A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation

Moderate

FDAJul 19, 2023Nationwide• Philips Medical Systems Nederland B.V. High Tech Campus 36 Eindhoven Netherlands

Tim Heung Yuen Black Melon Seeds (Richin Trading) – Undeclared Allergens (2023)

Undeclared Allergen

Undeclared allergens; soy and wheat

Class IHigh

FDAJul 19, 2023CA, CO, FL +9 more• Richin Trading Inc

MultiDiagnost-Eleva (Philips) – Unintended Radiation Emission (2023)

A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation

Moderate

FDAJul 19, 2023Nationwide• Philips Medical Systems Nederland B.V. High Tech Campus 36 Eindhoven Netherlands

Portex Hydrophobic Filter (Smiths Medical) – Labeling Error (2023)

Smiths Medical identified a labeling error in which the barcode (UDI) was not correctly reflecting the expiration date of the product

Low

FDAJul 18, 2023Nationwide• Smiths Medical ASD Inc.

Proclaim Plus 7 Pulse Generator (Abbott) – MRI Mode Malfunction (2023)

Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).

Moderate

FDAJul 18, 2023Nationwide• Abbott Medical

Proclaim XR 5 Pulse Generator (Abbott) – MRI Mode Malfunction (2023)

Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).

Moderate

FDAJul 18, 2023Nationwide• Abbott Medical

Proclaim XR 7 Pulse Generator (Abbott) – MRI Mode Malfunction (2023)

Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).

Moderate

FDAJul 18, 2023Nationwide• Abbott Medical

Proclaim Plus 5 Pulse Generator (Abbott) – MRI Mode Malfunction (2023)

Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).

Moderate

FDAJul 18, 2023Nationwide• Abbott Medical

Infinity 5 Pulse Generator (Abbott) – MRI Mode Malfunction (2023)

Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).

Moderate

FDAJul 18, 2023Nationwide• Abbott Medical

Infinity 7 Pulse Generator (Abbott) – MRI Mode Malfunction (2023)

Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).

Moderate

FDAJul 18, 2023Nationwide• Abbott Medical

Dofetilide Capsules (Sun Pharma) – Content Uniformity Issue (2023)

Out of Specification result observed in content uniformity testing

Class IIILow

FDAJul 18, 2023Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Proclaim DRG Pulse Generator (Abbott) – MRI Mode Malfunction (2023)

Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).

Moderate

FDAJul 18, 2023Nationwide• Abbott Medical

Aquilex Fluid System (WOM) – Volume Display Limit (2023)

The display of inflow volume can reach its limit of 30,000 ml during long procdeure and the inflow volume display will freeze at the maximum value while the deficit will start counting backwards until 0 ml is reached and may result in fluid overload

High

FDAJul 17, 2023Nationwide• WOM World Of Medicine AG Alte Poststr. 11 Ludwigsstadt Germany