recall database
FDA Recalls
An FDA recall is a company- or FDA-initiated removal or correction of a drug or medical device already on the market because it is defective or could be a health risk. Argus HQ tracks 4,082 published recalls from 2026 to 2026, filterable by classification (Class I, II, or III), year, and product category, each sourced from and linked back to fda.gov.
- Heidelberg Engineering GmbH — Class II recall: Brand Name: Heidelberg Engineering GmbH Product Name: SPECTRALIS with Flex Modu…
Heidelberg Engineering GmbH·Class II·Medical device·September 30, 2026
- AVID Medical, Inc. — Class I recall: Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Cle…
AVID Medical, Inc.·Class I — most serious·Medical device·September 30, 2026
- CooperSurgical, Inc. — Class I recall: INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set. Stay-Fle…
CooperSurgical, Inc.·Class I — most serious·Medical device·September 30, 2026
- Philips North America Llc — Class II recall: Ingenia 1.5T, Ingenia 1.5T CX and Ingenia 1.5T S; Model Numbers (REF): 1. 78131…
Philips North America Llc·Class II·Medical device·September 30, 2026
- AVID Medical, Inc. — Class II recall: Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Cle…
AVID Medical, Inc.·Class II·Medical device·September 30, 2026
- Medline Industries, LP — Class II recall: Medline convenience kits containing Healthmark Instrument Channel Brushes. SINUS…
Medline Industries, LP·Class II·Medical device·September 30, 2026
- Philips North America Llc — Class II recall: MR 5300 Model Number (REF): 1. 782110, 2. 782152;
Philips North America Llc·Class II·Medical device·September 30, 2026
- Maquet SAS — Class II recall: PowerLED 300 Concealed Lighting System (PWD30+SF W K3 SPRING ARM A2 FC3 50-100nm…
Maquet SAS·Class II·Medical device·September 30, 2026
- Sterling Pharmaceutical Services LLC — Class II recall: Reliable-1 Laboratories Lubricating Tears, Sterile, 0.5 FL OZ (15 mL) bottles, D…
Sterling Pharmaceutical Services LLC·Class II·Drug·September 30, 2026
- Midmark Corporation — Class II recall: Midmark IQvitals Zone, automatically and noninvasively measures systolic and dia…
Midmark Corporation·Class II·Medical device·September 30, 2026
- Ventec Life Systems, Inc. — Class II recall: REF: HF2POSTD HomeFill Oxygen System HomeFill cylinder D with CGA870 Compatibl…
Ventec Life Systems, Inc.·Class II·Medical device·September 30, 2026
- Sterling Pharmaceutical Services LLC — Class II recall: TRP The Relief Products* Gentle Eyes Lubricant Eye Drops, Carboxymethylcellulose…
Sterling Pharmaceutical Services LLC·Class II·Drug·September 30, 2026
- Amneal Pharmaceuticals of New York, LLC — Class II recall: Exenatide Injection, USP, 250 mcg/mL, 1.2 mL per prefilled pen, Rx Only, Subcuta…
Amneal Pharmaceuticals of New York, LLC·Class II·Drug·September 30, 2026
- Olympus Corporation of the Americas — Class II recall: Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector. Model/Catalog Number: C…
Olympus Corporation of the Americas·Class II·Medical device·September 30, 2026
- INTERVASCULAR, SAS — Class II recall: Cardioroot Woven Collagen Coated Vascular Graft; Model Numbers: 1. HEWROOT0024,…
INTERVASCULAR, SAS·Class II·Medical device·September 30, 2026
- Cardinal Health 200, LLC — Class II recall: Presource Convenience Kits: 1) KIT, PRE OP , Catalog Number:…
Cardinal Health 200, LLC·Class II·Medical device·September 30, 2026
- Philips Ultrasound, LLC — Class II recall: Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234
Philips Ultrasound, LLC·Class II·Medical device·September 30, 2026
- Ventec Life Systems, Inc. — Class II recall: HF2P0ST9 HomeFill Oxygen System HomeFill Cylinder M9 with CGA870 Compatible Po…
Ventec Life Systems, Inc.·Class II·Medical device·September 30, 2026
- Philips North America Llc — Class II recall: Achieva 1.5T, Achieva 1.5T Conversion and Achieva 1.5T Initial system; Model Nu…
Philips North America Llc·Class II·Medical device·September 30, 2026
- Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company — Class II recall: Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops (glycerin 0.25%,…
Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company·Class II·Drug·September 30, 2026
- New York Embroidery Studio, Inc. — Class II recall: New York Embroidery Studio Trinity Non-Surgical Isolation Gown, AAMI PB70 Level…
New York Embroidery Studio, Inc.·Class II·Medical device·September 30, 2026
- Ventec Life Systems, Inc. — Class II recall: REF:HF2PC9 HomeFill Oxygen System, HomeFill Cylinder M9 with Integrated Conserv…
Ventec Life Systems, Inc.·Class II·Medical device·September 30, 2026
- Midmark Corporation — Class II recall: Midmark IQvitals Zone, automatically and noninvasively measures systolic and dia…
Midmark Corporation·Class II·Medical device·September 30, 2026
- SEASPINE ORTHOPEDICS CORPORATION — Class II recall: SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gim…
SEASPINE ORTHOPEDICS CORPORATION·Class II·Medical device·September 30, 2026
- Philips North America Llc — Class II recall: Ingenia Ambition S and Ingenia Ambition X; Model Numbers (REF): 1. 781359 (S),…
Philips North America Llc·Class II·Medical device·September 30, 2026