enforcement database
FDA Medical Device Recalls
3,517 documented actions on record. FDA recalls of medical devices, from Class I (reasonable probability of serious injury or death) through Class III.
- Total actions
- 3,517
- Earliest on record
- January 11, 2023
- Most recent
- September 30, 2026
- Source
- openFDA (recall)
Severity breakdown
- Critical636
- High2,782
- Medium99
Most recent medical device recalls (30 of 3,517 shown)
- Midmark Corporation — Class II recall: Midmark IQvitals Zone, automatically and noninvasively measures systolic and dia…
September 30, 2026·High
- Philips North America Llc — Class II recall: Achieva XR; Model Numbers (REF): 1. 781153, 2. 781253;
September 30, 2026·High
- Philips North America Llc — Class II recall: MR 7700 and Upgrade to MR 7700; Model Number (REF): 1. 782120, 2. 782153, 3. 78…
September 30, 2026·High
- Philips North America Llc — Class II recall: Evolution upgrade 1.5T and Evolution upgrade 3.0T; Model Numbers (REF): 1. 7821…
September 30, 2026·High
- DeRoyal Industries Inc — Class II recall: REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series
September 30, 2026·High
- CooperVision, Inc. — Class II recall: Brand Name: Pearle Vision 1 day Product Name: (somofilcon A) Contact Lens Mode…
September 30, 2026·High
- CooperSurgical, Inc. — Class I recall: INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set. Stay-Flex tub…
September 30, 2026·Critical
- Becton, Dickinson and Company — Class II recall: ForeSight Elite Tissue Oximetry Cable REF HEMFSM10 UDI-DI code: 00690103210927…
September 30, 2026·High
- Criticare Technologies, Inc. — Class II recall: nGenuity Patient Monitor with Capnography (ETCO2) CAT 8100E1-ST-US, CAT 8100E…
September 30, 2026·High
- Olympus Corporation of the Americas — Class II recall: Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector. Model/Catalog Number: CD…
September 30, 2026·High
- Philips North America Llc — Class II recall: Ingenia 3.0T and Ingenia 3.0T CX; Model Numbers (REF): 1. 781342(3.0T), 2. 7813…
September 30, 2026·High
- Boston Scientific Corporation — Class I recall: Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5; M0…
September 30, 2026·Critical
- Olympus Corporation of the Americas — Class II recall: Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Num…
September 30, 2026·High
- Olympus Corporation of the Americas — Class II recall: Olympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector. Model/Catalog Number: CD-…
September 30, 2026·High
- Fresenius Medical Care Renal Therapies Group, LLC — Class II recall: CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer…
September 30, 2026·High
- Biomerieux Inc — Class II recall: VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Ref…
September 30, 2026·High
- Philips North America Llc — Class II recall: Achieva 3.0T; Model Numbers (REF): 1. 781177, 2. 781277, 3. 781278, 4. 781344,…
September 30, 2026·High
- Philips North America Llc — Class II recall: Ingenia Elition S and Ingenia Elition X; Model Numbers (REF): 1. 781357(S), 2.…
September 30, 2026·High
- Heidelberg Engineering GmbH — Class II recall: Brand Name: Heidelberg Engineering GmbH Product Name: SPECTRALIS with Flex Modu…
September 30, 2026·High
- AVID Medical, Inc. — Class I recall: Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Cle…
September 30, 2026·Critical
- CooperSurgical, Inc. — Class I recall: INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set. Stay-Fle…
September 30, 2026·Critical
- Philips North America Llc — Class II recall: Ingenia 1.5T, Ingenia 1.5T CX and Ingenia 1.5T S; Model Numbers (REF): 1. 78131…
September 30, 2026·High
- AVID Medical, Inc. — Class II recall: Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Cle…
September 30, 2026·High
- Medline Industries, LP — Class II recall: Medline convenience kits containing Healthmark Instrument Channel Brushes. SINUS…
September 30, 2026·High
- Philips North America Llc — Class II recall: MR 5300 Model Number (REF): 1. 782110, 2. 782152;
September 30, 2026·High
- Maquet SAS — Class II recall: PowerLED 300 Concealed Lighting System (PWD30+SF W K3 SPRING ARM A2 FC3 50-100nm…
September 30, 2026·High
- Midmark Corporation — Class II recall: Midmark IQvitals Zone, automatically and noninvasively measures systolic and dia…
September 30, 2026·High
- Ventec Life Systems, Inc. — Class II recall: REF: HF2POSTD HomeFill Oxygen System HomeFill cylinder D with CGA870 Compatibl…
September 30, 2026·High
- Olympus Corporation of the Americas — Class II recall: Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector. Model/Catalog Number: C…
September 30, 2026·High
- INTERVASCULAR, SAS — Class II recall: Cardioroot Woven Collagen Coated Vascular Graft; Model Numbers: 1. HEWROOT0024,…
September 30, 2026·High
Other enforcement types
Sourced from openFDA public enforcement data. Not legal or regulatory advice. Report an error via /contact.