Latest U.S. Recalls — FDA & NHTSA Records

Latest records

Latest recalls — page 65

The newest recall records with useful source details are listed here.

DrugApr 8, 2026

LEADER ARTIFICIAL TEARS 15 ML Artificial Tears Sterile Lubricant Eye Drops recall — FDA D-0416-2026

Lack of Assurance of Sterility

Class IIFDA: OngoingK.C. Pharmaceuticals, Inc

DrugApr 8, 2026

Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag recall — FDA D-0478-2026

Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained an IV bag of Tranexamic Acid instead.

Class IFDA: OngoingAmneal Pharmaceuticals, LLC

DrugApr 8, 2026

Prazosin Hydrochloride Capsules, USP, 2mg, 100-count bottle recall — FDA D-0420-2026

cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.

Class IIFDA: OngoingAppco Pharma LLC

DrugApr 8, 2026

traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles recall — FDA D-0408-2026

Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability interval during Long term stability…

Class IIFDA: OngoingAmneal Pharmaceuticals, LLC

DrugApr 8, 2026

Prazosin Hydrochloride Capsules, USP, 1mg, 100-count bottle recall — FDA D-0419-2026

cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.

Class IIFDA: OngoingAppco Pharma LLC

Medical DeviceApr 1, 2026

Philips Respironics Trilogy Evo, Software Version 1.05.15.00 recall — FDA Z-1614-2026

Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.

Class IFDA: OngoingPhilips Respironics, Inc.

Medical DeviceApr 1, 2026

Medline Industries Puracol and Puracol Plus Collagen Wound Dressings: MSC8522 recall — FDA Z-1650-2026

Elevated endotoxin levels identified in affected lots. Issue may elicit strong inflammatory response if used, including local tissue irritation, delayed wound healing, or systemic effects…

Class IIFDA: OngoingMedline Industries, LP

Medical DeviceApr 1, 2026

I.T.S. GmbH Pelvic Reconstruction System (PRS) with the below descriptions and corresponding recall — FDA Z-1600-2026

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

Class IIFDA: OngoingI.T.S. GmbH

Medical DeviceApr 1, 2026

Olympus HALO PKS Cutting Forceps, 5mm 33cm HALO PKS Cutting Forceps recall — FDA Z-1641-2026

Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw…

Class IIFDA: OngoingOlympus Corporation of the Americas

Medical DeviceApr 1, 2026

Beckman Coulter MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 MicroScan panels recall — FDA Z-1609-2026

Due to the likely presence of contamination in well(s).

Class IIFDA: OngoingBeckman Coulter, Inc.

Medical DeviceApr 1, 2026

I.T.S. GmbH Volar Radius Plate with Angular Stability with the following description: Radius recall — FDA Z-1592-2026

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

Class IIFDA: OngoingI.T.S. GmbH

Medical DeviceApr 1, 2026

BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe recall — FDA Z-1631-2026

Product labeling includes a fetal indication for use that is not cleared under its 510(k).

Class IIFDA: OngoingKoven Technology, Inc.

Medical DeviceApr 1, 2026

Olympus PKS Cutting Forceps, 5mm 33cm PKS Cutting Forceps recall — FDA Z-1644-2026

Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw…

Class IIFDA: OngoingOlympus Corporation of the Americas

Medical DeviceApr 1, 2026

Olympus Everest Bipolar Cutting Forceps w/Cord, 5mm 33 cm Everest Bipolar Cutting Forceps recall — FDA Z-1639-2026

Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw…

Class IIFDA: OngoingOlympus Corporation of the Americas

Medical DeviceApr 1, 2026

I.T.S. GmbH Pilonplate with Angular Stability, with the below descriptions and corresponding recall — FDA Z-1596-2026

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

Class IIFDA: OngoingI.T.S. GmbH

Medical DeviceApr 1, 2026

I.T.S. GmbH FR.O.H. Calcaneus Repair System with the following description: Anterolateral recall — FDA Z-1595-2026

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

Class IIFDA: OngoingI.T.S. GmbH

Medical DeviceApr 1, 2026

Straumann USA Custom Abutment AS Ti, for Straumann RC, incl recall — FDA Z-1633-2026

A material mix-up had occurred during the manufacturing of Straumann Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot 7130439) was incorrectly…

Class IIFDA: OngoingStraumann USA LLC

Medical DeviceApr 1, 2026

Waldemar Link GmbH & Co. KG Embrace Drill Tower, Standard/Lateral (25mm) recall — FDA Z-1652-2026

The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described…

Class IIFDA: OngoingWaldemar Link GmbH & Co. KG (Mfg Site)

Medical DeviceApr 1, 2026

I.T.S. DUL (Distal Ulna Locking) System and UOL (Ulna Osteotomy Locking) System with the recall — FDA Z-1604-2026

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

Class IIFDA: OngoingI.T.S. GmbH

Medical DeviceApr 1, 2026

Humeral Head Plate with Angular Stability, with the following description: Proximal Humeral recall — FDA Z-1594-2026

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

Class IIFDA: OngoingI.T.S. GmbH

Medical DeviceApr 1, 2026

Merit Medical Systems DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A recall — FDA Z-1578-2026

16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis,…

Class IFDA: OngoingMerit Medical Systems, Inc.

Medical DeviceApr 1, 2026

I.T.S. GmbH Claviculaplate with Angular Stability, with the below descriptions and recall — FDA Z-1593-2026

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

Class IIFDA: OngoingI.T.S. GmbH

Medical DeviceApr 1, 2026

Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Everest Bipolar Cutting Forceps recall — FDA Z-1638-2026

Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw…

Class IIFDA: OngoingOlympus Corporation of the Americas

Medical DeviceApr 1, 2026

TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System recall — FDA Z-1634-2026

Due to identifying a limited quantity of intraocular lenses that may have a haptic that sticks to the optic which prevents the lens from unfolding as consistently as expected.

Class IIFDA: OngoingAMO Puerto Rico Manufacturing, Inc.

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