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ACCORD HEALTHCARE, INC.

ACCORD HEALTHCARE, INC. Recalls

All product recalls associated with ACCORD HEALTHCARE, INC..

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Recall Summary

Total Recalls

249

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 21–40 of 249 recalls

Levothyroxine Sodium Tablets (Accord Healthcare) – Subpotent Drug (2024)

Subpotent drug

Class IIModerate

FDANov 8, 2024Nationwide• ACCORD HEALTHCARE, INC.

Cigar Slim Lighters (Oliva) – Safety Concern (2024)

Fire/Burn Risk

This recall involves Oliva Cigar Nub, Oliva, Serie V and Cain branded cigar lighters given away as a promotional item for free. The recalled lighters have the brand name printed on one side, measure 3" x 1 ½" x ¼" and are white, brown or red in color.

CPSCOct 17, 2024Nationwide• Wenzhou LingShuo Smoking Accessories Co. Ltd., of China

Cinacalcet Tablets 90mg (Accord) – Nitrosamine Impurity (2024)

CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

123 4...13

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Class IIModerate

FDAOct 10, 2024Nationwide• ACCORD HEALTHCARE, INC.

Cinacalcet Tablets 60mg (Accord) – Nitrosamine Impurity (2024)

CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

Class IIModerate

FDAOct 10, 2024Nationwide• ACCORD HEALTHCARE, INC.

Cinacalcet Tablets 30mg (Accord) – Nitrosamine Impurity (2024)

CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

Class IIModerate

FDAOct 10, 2024Nationwide• ACCORD HEALTHCARE, INC.

Cisplatin Injection (Accord Healthcare) – Impurity Specifications (2024)

Failed Impurities/Degradation Specifications.

Class IIModerate

FDAOct 1, 2024Nationwide• ACCORD HEALTHCARE, INC.

AVOXimeter 1000E (Accriva) – Calibration Value Inaccuracy (2024)

Values used to calibrate whole blood oximeter instruments were observed to be higher than normal, which may result in incorrect patient results where oxygen levels are higher than actual results, which may lead to patient care mismanagement requiring medical intervention.

FDASep 27, 2024AZ• Accriva Diagnostics, Inc.

Pluvicto Injection (Advanced Accelerator) – Manufacturing Deviations (2024)

CGMP deviations

Class IIModerate

FDASep 23, 2024FL, MA, NJ +3 more• Advanced Accelerator Applications USA, Inc.

Dodex Injectable (Accord Healthcare) – Subpotent Drug (2024)

Subpotent drug: out of specification results

Class IIILow

FDAJun 18, 2024Nationwide• Accord Healthcare, Inc.

Ford Bronco Sport Hood Scoop (Ford) – accessory issue (2024)

Ford Motor Company (Ford) is recalling certain Ford Bronco Sport Hood Scoops with part number VM1PZ-16C630-A, that were sold as accessory parts for 2021-2024 Bronco Sport vehicles. The hood scoop may detach from the vehicle.

NHTSAApr 12, 2024Nationwide• FORD ACCESSORY PARTS

FORD ACCESSORY PARTS REAR SEAT COVER Equipment Recall: SEATS

Ford Motor Company (Ford) is recalling certain Ford EcoSport Rear Seat Covers with part number VNJ1Z-6163812-A/B. The rear seat covers may prevent the air bag from deploying correctly.

NHTSAFeb 23, 2024Nationwide• FORD ACCESSORY PARTS

Accure Acne, Inc: Accure Laser System, Model: PFMS00004

Laser system's spot tracking system may become misaligned resulting in the possible risk of delivery of higher-than-expected laser energy to epidermal tissue, which may cause blistering.

FDADec 6, 2023CA, CO, CT +7 more• Accure Acne, Inc

Draegerwerk Ag & Co. Kgaa Dragerwerk Ag & Co. Kgaa Accounts Payable Moislinger Allee: Atlan, Gas Machine for Anesthesia or Analgesia, Catalog n...

Internal backup battery may fail spontaneously while the Atlan is being operated without AC mains supply, resulting in unexpected shutdown of the device while running on batteries.

FDANov 17, 2023IN• Draegerwerk Ag & Co. Kgaa Dragerwerk Ag & Co. Kgaa Accounts Payable Moislinger Allee

Acclarent, Inc.: TruDi Navigation System, Model: FG-2000-00, Catalog: ENS0...

When using affected curette and software, there is a discrepancy between the actual curette tip location and the location displayed on navigation systems intended for use during surgical procedures of the Ear Nose and Throat (ENT) and ENT skull base surgery, which may cause delayed/prolonged surgery, cerebrospinal fluid leak, visual impairment, or skull base structural damage.

FDASep 21, 2023AL, AZ, CA +27 more• Acclarent, Inc.

Access Vascular, Inc: HydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Pro...

Specific lots of the Dual Lumen HydroPICC Kits were provided with the incorrect revision of the Instructions For Use (IFU) which do not include the following warnings statement: HydroPICC Dual Lumen Catheter is for adult use only. There is a potential risk to health should the HydroPICC Dual Lumen Catheter be used in an inadequately sized vessel. There have been no reported adverse events to date.

FDAAug 31, 2023Nationwide• Access Vascular, Inc

Access Vascular, Inc: HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product M...

FDAAug 31, 2023Nationwide• Access Vascular, Inc

Pluvicto (Advanced Accelerator) – Incorrect Labeling (2023)

Labeling: Incorrect or Missing Lot and/or Exp Date: vials were labeled with the incorrect lot number and expiration date

Class IIILow

FDAAug 7, 2023Nationwide• Advanced Accelerator Applications USA, Inc.

Accuray Incorporated: Upper roller bracket (part number 1088370) for the Gen2 g...

It is possible the upper roller bracket in the Radixact System gantry enclosure may not provide enough clearance for service personnel to use a jib crane for moving components while servicing the system, resulting in possible injury to the service personnel.

FDAAug 3, 2023Nationwide• Accuray Incorporated

Atropine Sulfate Injection (Accord) – Particulate Matter (2023)

Presence of Particulate Matter: Particulate matter identified as fiber.

Class IIModerate

FDAJul 3, 2023Nationwide• Accord Healthcare, Inc.

Bivalirudin Injection (Accord) – Particulate Matter (2023)

Presence of Particulate Matter: Particulate matter identified as fiber.

Class IIModerate

FDAJul 3, 2023Nationwide• Accord Healthcare, Inc.