DrugApr 8, 2026
LEADER ULTRA LUBRICATING EYE DROPS Ultra Lubricating Eye Drops recall — FDA D-0412-2026
Lack of Assurance of Sterility
Class IIFDA: OngoingK.C. Pharmaceuticals, Inc
Monthly breakdown
2026 recalls by month
Select a month to review the recall records reported during that period.
August 2026145 records · 4 categoriesJuly 2026369 records · 4 categoriesJune 2026373 records · 4 categoriesMay 2026330 records · 4 categoriesApril 2026407 records · 4 categoriesMarch 2026179 records · 4 categoriesFebruary 2026329 records · 4 categoriesJanuary 2026210 records · 4 categories
2026 recalls — page 65
Records are ordered by the best available source date.
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
About the 2026 recall archive
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.