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Mallinckrodt Hospital Products Inc.

Mallinckrodt Hospital Products Inc. Recalls

All product recalls associated with Mallinckrodt Hospital Products 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 201–220 of 2399 recalls

Acthar Gel (Mallinckrodt) – Shipping Temperature Issue (2024)

cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.

Class IIModerate

FDAFeb 6, 2024Nationwide• Mallinckrodt Hospital Products Inc.

EasyPoint Needle (Retractable) – Detachment Risk (2024)

The needle cannula of a retractable needle may detach from the needle holder in the patient.

FDAFeb 5, 2024Nationwide• Retractable Technologies, Inc.

Omeprazole Suspension (Bausch Health) – Subpotent Drug (2024)

Subpotent Drug: Out of specification for assay

Class IIModerate

1...9 101112 13...120

Page 11 of 120Next

FDA

Feb 2, 2024

Nationwide

• Bausch Health Companies, Inc.

Stay-Safe Luer Lock Catheter Extension (Fresenius) – Leachable Concerns (2024)

The peroxide cross-linked tubing has leachables identified as NDL PCBAs.

FDAJan 23, 2024Nationwide• Fresenius Medical Care Holdings, Inc.

Stay-Safe Luer Lock Adapter (Fresenius) – Leachable Concerns (2024)

The peroxide cross-linked tubing has leachables identified as NDL PCBAs.

FDAJan 23, 2024Nationwide• Fresenius Medical Care Holdings, Inc.

Stay-Safe Luer Catheter Extension (Fresenius) – Leachable Concerns (2024)

The peroxide cross-linked tubing has leachables identified as NDL PCBAs.

FDAJan 23, 2024Nationwide• Fresenius Medical Care Holdings, Inc.

Stay-Safe Safe Lock Catheter Extension (Fresenius) – Leachable Concerns (2024)

The peroxide cross-linked tubing has leachables identified as NDL PCBAs.

FDAJan 23, 2024Nationwide• Fresenius Medical Care Holdings, Inc.

Adrenalin Epinephrine Injection (Henry Schein) – Incorrect Labeling (2024)

Labeling: Incorrect or Missing Lot and/or Exp Date. The expiration date listed on the Repack Pouch Label is incorrect.

Class IIModerate

FDAJan 17, 2024Nationwide• Henry Schein Inc. and Glove Club HSI Gloves Inc.

Apollo Onyx Delivery Microcatheter (Micro Therapeutics) – Indications Mismatch (2024)

European version of microcatheter were distributed within US which contain a different "Indications for Use".

FDAJan 11, 2024Nationwide• Micro Therapeutics, Inc.

365 Whole Foods Vegan Pizza (Richelieu) – undeclared milk (2023)

Undeclared Milk

Undeclared milk

Class IIILow

FDADec 29, 2023GA, PA, TX +1 more• Richelieu Foods, Inc.

DELFLEX Peritoneal Dialysis Solution (Fresenius) – Sterility Concern (2023)

Lack of Sterility Assurance

Class IIModerate

FDADec 28, 2023Nationwide• Fresenius Medical Care Holdings, Inc.

Natures Wonder Premium Bean Sprouts (Chang & Son) – Listeria contamination (2023)

Listeria

Product contaminated with Listeria monocytogenes.

Class IHigh

FDADec 15, 2023CT, MD, MA +1 more• Chang & Son Enterprises, Inc.

Cortera Spinal Fixation System (XTANT) – Screw Shank Incorrect (2023)

Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length were manufactured using an incorrect screw shank component, and so the labeling is incorrect because the affected screws are in fact 5.5 diameter, 45 mm length screws, which if used may lead to the screw not engaging.

FDANov 28, 2023IN, MI• XTANT Medical Holdings, Inc

Captus 4000e Thyroid Uptake System – Spring Arm Failure (2023)

Spring arm failure with Captus 4000e Thyroid Uptake Systems, can cause the collimator to fall downward to its lowest point of travel, causing potential injury with a patient or operator

FDANov 27, 2023Nationwide• Mirion Technologies (Capintec), Inc.

CORI Robotic Drill (Blue Belt) – Disconnection Errors (2023)

Possibility that the user is unable to resolve drill disconnection error messages.

FDANov 13, 2023Nationwide• Blue Belt Technologies, Inc

Vitrakvi Oral Solution (Bayer) – Microbial Contamination (2023)

Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing

Class IHigh

FDANov 6, 2023Nationwide• Bayer Healthcare Pharmaceuticals Inc.

Liberty Select Cycler (Fresenius) – timestamp error (2023)

Affected Liberty Select cyclers may display an incorrect time stamp on the treatment data report sent to the clinic.

FDAOct 24, 2023Nationwide• Fresenius Medical Care Holdings, Inc.

Stay Safe Cap (Fresenius Medical) – Additional Warnings (2023)

Updating the labeling to include additional warnings and contraindications for potential side effects.

FDAOct 10, 2023Nationwide• Fresenius Medical Care Holdings, Inc.

BD Insyte IV Catheter (Becton Dickinson) – Needle Retraction Issue (2023)

Over-the-needle, intravascular catheters may have needles that do not retract properly into the barrel, which could result in contaminated needlestick injury, blood leaking from the insertion site or catheter, and repeat catheter insertion attempts, due to catheter being inadvertently removed from the insertion site.

FDAOct 4, 2023Nationwide• Becton Dickinson Infusion Therapy Systems Inc.

Blood Uric Acid Monitoring System (Visgeneer) – Unapproved Distribution (2023)

Due to products distributed without premarket clearance or approvals.

FDAOct 4, 2023Nationwide• Visgeneer, Inc. No. 335 Zhong Hua Rd., Sec. 6 Xiangshan Dist. Hsinchu City Taiwan