Device recalls
Device recalls with the root cause, the firm, the products and the recall status. 59,705 records; openFDA updated it 2026-11-13. About this dataset
Newest records
- Other8,928
- Device Design7,678
- Under Investigation by firm7,031
- Process control6,625
- Nonconforming Material/Component5,990
- Software design3,532
- Packaging1,667
- Component design/selection1,611
- Senographe PristinaFDA page
GE Medical Systems, LLC · GE HealthCare has become aware of a nonconformance to certain Senographe Pristina VIA systems. Specifically, in cases of 3D+2D manual mode where the acquisitio…
- Senographe PristinaFDA page
GE Medical Systems, LLC · GE HealthCare has become aware of a nonconformance to certain Senographe Pristina VIA systems. Specifically, in cases of 3D+2D manual mode where the acquisitio…
- Senographe Pristina 3DFDA page
GE Medical Systems, LLC · GE HealthCare has become aware of a nonconformance to certain Senographe Pristina VIA systems. Specifically, in cases of 3D+2D manual mode where the acquisitio…
- intelerad IntelePACS softwareFDA page
INTELERAD MEDICAL SYSTEMS INCORPORATED · A cybersecurity vulnerability has been identified in the software that could allow a malicious user to take over an administrator session, delete or modify ima…
- Halyard MINOR PACK. Model/Catalog Number: VASF105-08.FDA page
AVID Medical, Inc. · Potential for open seals on header bags, compromising sterility.
- TruSystem 7000 U Operating Table (dV), Product Code 1723633FDA page
Baxter Healthcare Corporation · The main lift may unexpectedly drop from its set position to its lowest position during use. The tabletop may not be able to be raised again after the drop occ…
- Mobile column TruSystem 7500 U, Product Code 1730720FDA page
Baxter Healthcare Corporation · The main lift may unexpectedly drop from its set position to its lowest position during use. The tabletop may not be able to be raised again after the drop occ…
- Generic Name: Perma Sharp Sutures; Generic Name: Polypropylene Suture; Model/Catalog Number: PSN8696P (Henry Schein Item No. 600-0115); Pro…FDA page
Henry Schein Inc. · Products lack 510(k) clearance.
- Generic Name: Perma Sharp Sutures; Generic Name: PGA Absorbable Surgical Suture; Model/Catalog Number: PSN397V (Henry Schein Item No. 600-0…FDA page
Henry Schein Inc. · Products lack 510(k) clearance.
- Generic Name: Perma Sharp Sutures; Generic Name: Silk Nonabsorbable Surgical Suture; Model/Catalog Number: PSN7772S (HSI Item No. 600-3090)…FDA page
Henry Schein Inc. · Products lack 510(k) clearance.
- Generic Name: Perma Sharp Sutures; Generic Name: Silk Nonabsorbable Surgical Suture; Model/Catalog Number: PSN632S (HSI Item No. 600-3506);…FDA page
Henry Schein Inc. · Products lack 510(k) clearance.
- Generic Name: Perma Sharp Sutures; Generic Name: Polypropylene Nonabsorbable Surgical Suture; Model/Catalog Number: PSN8698P (HSI Item No.…FDA page
Henry Schein Inc. · Products lack 510(k) clearance.
- Generic Name: Perma Sharp Sutures; Generic Name: Silk Nonabsorbable Surgical Suture; Model/Catalog Number: PSN683S (HSI Item No. 600-6411);…FDA page
Henry Schein Inc. · Products lack 510(k) clearance.
- Generic Name: Perma Sharp Sutures; Generic Name: PGA Absorbable Surgical Suture; Model/Catalog Number: PSN421V (HSI Item No. 600-6870); Pro…FDA page
Henry Schein Inc. · Products lack 510(k) clearance.
- Generic Name: Perma Sharp Sutures; Generic Name: Polypropylene Nonabsorbable Surgical Suture; Model/Catalog Number: PSN8660P (HSI Item No.…FDA page
Henry Schein Inc. · Products lack 510(k) clearance.
- Generic Name: Perma Sharp Sutures; Generic Name: Polypropylene Nonabsorbable Surgical Suture; Model/Catalog Number: PSN8384P (HSI Item No.…FDA page
Henry Schein Inc. · Products lack 510(k) clearance.
- Generic Name: Perma Sharp Sutures; Generic Name: PGA Absorbable Surgical Suture; Model/Catalog Number: PSN388V (HSI Item No. 600-8803); Pro…FDA page
Henry Schein Inc. · Products lack 510(k) clearance.
- Generic Name: Perma Sharp Sutures; Generic Name: PGA Absorbable Surgical Suture; Model/Catalog Number: PSN392V (HSI Item No. 600-9613); Pro…FDA page
Henry Schein Inc. · Products lack 510(k) clearance.
- Generic Name: Perma Sharp Sutures; Generic Name: PGA Absorbable Surgical Suture; Model/Catalog Number: PSN387V (HSI Item No. 600-9683); Pro…FDA page
Henry Schein Inc. · Products lack 510(k) clearance.
- Generic Name: Perma Sharp Sutures; Generic Name: Polypropylene Nonabsorbable Surgical Suture; Model/Catalog Number: PSN8695P (HSI Item No.…FDA page
Henry Schein Inc. · Products lack 510(k) clearance.
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.