Stay Informed

Get email alerts when new recalls match your interests.

Recall data is updated hourly from official government sources. Very recent recalls may not yet appear. About our data sources

About

We make U.S. recall data searchable and accessible for consumers and businesses.

Site

FAQ
Browse by State
Statistics
Recall Classifications
About
Enterprise API

Legal

Privacy Policy
Terms of Service
Report Incorrect Info

Official Sources

FDA Recalls ↗
USDA FSIS ↗
CPSC Recalls ↗
NHTSA Recalls ↗

RSS Feed

Home
/
Brands
/
Ortho-Clinical Diagnostics, Inc.

Ortho-Clinical Diagnostics, Inc. Recalls

All product recalls associated with Ortho-Clinical Diagnostics, Inc..

Get alerts for this brand

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 941–960 of 21319 recalls

VITROS Chemistry CRP Slides (Ortho-Clinical) – Labeling Error (2025)

Product was incorrectly assigned GEN 88 instead of GEN 83 on product carton, foil wrapper, and cartridge (cart) label.

Moderate

FDAApr 14, 2025Nationwide• Ortho-Clinical Diagnostics, Inc.

Augmedics Perc Pin Adaptor (Augmedics) – Tightening Marking (2025)

The perc pin adaptor AMCH07200 tightening knob was found to be inconvenient to the user and the tightening markings found to be improperly placed.

Moderate

FDAApr 14, 2025Nationwide• Augmedics Ltd. 2 Ha-Otsma St Yokneam Illit Northern Israel

Duloxetine Capsules (Breckenridge) – Nitrosamine Impurity (2025)

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.

Class II

1...46 474849 50...1066

Page 48 of 1066Next

Moderate

FDAApr 14, 2025Nationwide• Breckenridge Pharmaceutical, Inc

ChlorproMAZINE Tablets (Harvard Drug) – Nitrosamine Impurity (2025)

CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit

Class IIModerate

FDAApr 14, 2025Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Duloxetine Capsules (Breckenridge) – Nitrosamine Impurity (2025)

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.

Class IIModerate

FDAApr 14, 2025Nationwide• Breckenridge Pharmaceutical, Inc

ZF North America Brake Chamber (ZF) – Brake Replacement (2025)

Fire/Burn Risk

Nova Bus (US) Inc. (Nova Bus) is recalling certain ZF North America Knorr-Bresme 20/22-57 brake chambers, with part number K038830N00, sold as replacement parts for certain buses. The brake chamber may have been improperly manufactured, which can result in an air leak.

High

NHTSAApr 14, 2025Nationwide• ZF NORTH AMERICA

Microtek Patient Drape (Microtek) – Sterility Concern (2025)

Due to non-sterile products being labeled as sterile

Moderate

FDAApr 13, 2025AL, AR, CA +17 more• Microtek Medical, Inc.

Centerline IOPS Guidewire (Centerline) – Coating Failure (2025)

Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire.

Moderate

FDAApr 11, 2025FL, NM, NY +5 more• Centerline Biomedical Inc

iGo2 DC Car Adapter (Medical Depot) – Power Supply Risk (2025)

Potential for DC Power Supply housing to become hot to the touch and deform the plastic housing.

Moderate

FDAApr 11, 2025Nationwide• Medical Depot Inc.

CADD-Solis VIP Pump (Smiths Medical) – Occlusion Alarm (2025)

Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.

Very High

FDAApr 10, 2025Nationwide• Smiths Medical ASD, Inc.

CADD Solis VIP Pump (Smiths Medical) – Thermal Damage (2025)

There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.

Moderate

FDAApr 10, 2025Nationwide• Smiths Medical ASD, Inc.

AirLife Infant Circuit (Vyaire) – Adapter Disconnect (2025)

Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any disconnection can result in severe consequences for neonates, including hypoxia, hypercapnia, and organ failure.

Moderate

FDAApr 10, 2025Nationwide• Vyaire Medical

ClomiPRAMINE Hydrochloride Capsules (Lupin) – Impurity Specification Failure (2025)

Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during 18-month long term stability study.

Class IIModerate

FDAApr 10, 2025Nationwide• Lupin Pharmaceuticals Inc.

CADD Solis Pump (Smiths Medical) – Wireless Connection (2025)

Pumps may experience Wireless Connection Modules intermittent connection alarms, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.

Very High

FDAApr 10, 2025Nationwide• Smiths Medical ASD, Inc.

CADD-Solis Infusion Pump (Smiths Medical) – Thermal Damage (2025)

There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.

Moderate

FDAApr 10, 2025Nationwide• Smiths Medical ASD, Inc.

CADD-Solis HPCA Pump (Smiths Medical) – Occlusion Alarm (2025)

Very High

FDAApr 10, 2025Nationwide• Smiths Medical ASD, Inc.

CMS8000 Patient Monitor (Contec) – Cybersecurity Risk (2025)

Patient monitor has nine identified cybersecurity vulnerabilities.

Moderate

FDAApr 10, 2025Nationwide• Contec Medical Systems Co., Ltd. Economic And No.

Chicco MyFit Child Seat (Chicco) – Seat Safety (2025)

Chicco USA, Inc. (Chicco) is recalling certain MyFit Zip Air Harness and Booster child restraint seats (CRS) with model numbers 07079561970070 and 04079561190070. In certain configurations, the child seat may allow excessive chest movement in a crash. As such, these child seats fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 213, "Child Restraint Systems."

Moderate

NHTSAApr 9, 2025Nationwide• CHICCO

FoundationOne Diagnostic (Foundation Medicine) – Variant Reporting (2025)

Four (4) total reports were sent to customers with clinically relevant variants requiring amendment, one (1) of which with an incorrect negative CDx claim. The remaining three (3) with tumor profiling result changes did not impact CDx indications.

Moderate

FDAApr 9, 2025Nationwide• Foundation Medicine, Inc.

PiezoWave 2 Control Unit (Richard Wolf) – Capacitor Failure (2025)

Fire/Burn Risk

The high voltage capacitor may fail early in the product life cycle after delivery of surge voltages. When this failure occurs, the capacitor may produce smoke and a burning smell. In extremely rare instances a capacitor may cause a spark or excessive heat when an internal capacitor failure occurs.

High

FDAApr 9, 2025GA• Richard Wolf GmbH Pforzheimer Str. 32 Knittlingen Germany