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FDA
H-0622-2026
|
Food |
High |
Apr 1, 2026
Recall: Jan 14, 2026
|
Details |
|
|
FDA
H-0596-2026
|
Food |
High |
Apr 1, 2026
Recall: Mar 3, 2026
|
Details |
|
|
FDA
H-0599-2026
|
Food |
High |
Apr 1, 2026
Recall: Mar 3, 2026
|
Details |
|
|
FDA
H-0628-2026
|
Food |
High |
Apr 1, 2026
Recall: Jan 24, 2026
|
Details |
|
|
FDA
Z-1613-2026
|
Medical Device |
High |
Apr 1, 2026
Recall: Feb 12, 2026
|
Details |
|
|
FDA
Z-1615-2026
|
Medical Device |
High |
Apr 1, 2026
Recall: Mar 2, 2026
|
Details |
|
|
FDA
Z-1590-2026
|
Medical Device |
High |
Apr 1, 2026
Recall: Feb 3, 2026
|
Details |
|
|
FDA
Z-1625-2026
|
Medical Device |
High |
Apr 1, 2026
Recall: Sep 5, 2025
|
Details |
|
|
FDA
Z-1643-2026
|
Medical Device |
High |
Apr 1, 2026
Recall: Feb 25, 2026
|
Details |
ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-NE5/C, DC21454035/C, DC21455550/C
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, impaired catheter function, loss of vessel for future vascular access.
|
FDA
Z-1576-2026
|
Medical Device |
High |
Apr 1, 2026
Recall: Feb 13, 2026
|
Details |
|
|
FDA
Z-1610-2026
|
Medical Device |
High |
Apr 1, 2026
Recall: Feb 12, 2026
|
Details |
Brand Name: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) with the below descriptions and corresponding article numbers. 1. Anterior Column Plate; Article Numbers: 21218-16, 21219-16. 2. Anterior Column Plate; Article Numbers: 21218-14, 21219-14. 3. Biplanar 2-Column Plate; Article Numbers: 21216-10, 21216-12, 21217-10, 21217-12. 4. Cancellous Screw; Article Numbers: 30591-36, 30591-70, 30591-75, 30591-80, 30591-85, 30591-90. 5. Cancellous Screw, Locking; Article Numbers: 37422-12-N, 37422-14-N, 37422-16-N, 37422-18-N, 37422-20-N, 37422-22-N, 37422-24-N, 37422-26-N, 37422-28-N, 37
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
|
FDA
Z-1608-2026
|
Medical Device |
High |
Apr 1, 2026
Recall: Jan 23, 2026
|
Details |
I.T.S. Straight Plate with Angular Stability with the below descriptions and corresponding article numbers. 1. Forearm Plate, Curved; Article Numbers: 21604-6, 21604-9. 2. Forearm Plate, Straight; Article Numbers: 21605-11, 21605-6, 21605-9. 3. Straight Compression Plate; Article Numbers: 21105-6, 21105-8. 4. Straight Plate, 1.5mm; Article Numbers: 21104-4, 21104-5, 21104-6, 21104-7, 21104-8, 21104-9. 5. Straight Plate, 2.0mm; Article Numbers: 21101-5, 21101-6, 21101-7, 21101-8, 21101-9, 21101-11, 21101-13. 6. Straight Plate, 3.5mm; Article Number: 21102-6. 7. Straight Plate, 4.5mm; Article Nu
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
|
FDA
Z-1598-2026
|
Medical Device |
High |
Apr 1, 2026
Recall: Jan 23, 2026
|
Details |
|
|
FDA
Z-1568-2026
|
Medical Device |
High |
Apr 1, 2026
Recall: Feb 12, 2026
|
Details |
CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/A, CENFP31K/A, CENFT15K, CENFT15K/D, CENFT17K, CENFT17K/A, CENFT17K/D, CENFT19K, CENFT19K/A, CENFT19K/B, CENFT19K/D, CENFT23K, CENFT23K/A, CENFT23K/B, CENFT23K/D, CENFT27K, CENFT27K/A, CENFT27K/B, CENFT27K/D, CENFT31K, CENFT31K/A, CENFT31K/B, CENFT31K/D
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, impaired catheter function, loss of vessel for future vascular access.
|
FDA
Z-1575-2026
|
Medical Device |
High |
Apr 1, 2026
Recall: Feb 13, 2026
|
Details |
Distal Humeral Plates with Angular Stability with the below descriptions and corresponding article numbers. 1. Cortical Screw, Locking; Article Numbers: 37351-10-N, 37351-12-N, 37351-14-N, 37351-16-N, 37351-18-N, 37351-20-N, 37351-22-N, 37351-24-N, 37351-26-N, 37351-28-N, 37351-30-N, 37351-32-N, 37351-34-N, 37351-36-N, 37351-38-N, 37351-40-N, 37351-42-N, 37351-44-N, 37351-46-N, 37351-48-N, 37351-50-N, 37351-55-N, 37351-60-N, 37351-65-N, 37351-70-N, 37351-75-N, 37351-80-N, 37351-85-N. 2. Humeral Plate, Distal; Article Numbers: 21241-5, 21241-7, 21242-7, 21243-10, 21244-9.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
|
FDA
Z-1602-2026
|
Medical Device |
High |
Apr 1, 2026
Recall: Jan 23, 2026
|
Details |
HLS - Hand Locking Plates System with the below descriptions and corresponding article numbers. 1. Cortical Screw; Article Numbers: 32151-6, 32151-8, 32151-9, 32151-10, 32151-11, 32151-12, 32151-13, 32151-14, 32151-15, 32151-16, 32151-18, 32151-20. 2. HLS Plate, 2 T-Shape; Article Numbers: 21505-4, 21506-4. 3. HLS Plate, 3 T-Shape; Article Numbers: 21507-4, 21508-4. 4. HLS Plate, Square; Article Numbers: 21517. 5. HLS Plate, Straight; Article Numbers: 21502, 21503-4, 21503-6, 21503-8, 21503-10, 21504-6, 21504-8, 21504-10. 6. HLS Plate, Y-Shape; Article Numbers: 21513-3, 21513-5, 21514-3, 21514
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
|
FDA
Z-1607-2026
|
Medical Device |
High |
Apr 1, 2026
Recall: Jan 23, 2026
|
Details |
|
|
FDA
Z-1642-2026
|
Medical Device |
High |
Apr 1, 2026
Recall: Feb 25, 2026
|
Details |
I.T.S. Screw System with the below descriptions and corresponding article numbers. 1. Cancellous Screw, Cannulated; Article Numbers: 31404-16, 31404-18, 31404-20, 31404-22, 31404-24, 31404-26, 31404-28, 31404-30, 31404-32, 31404-34, 31404-36, 31404-38, 31404-40, 31404-42, 31404-44, 31404-46, 31404-48, 31404-50, 31404-55, 31404-60, 31404-65, 31404-70, 31404-75, 31404-80, 31457-30, 31457-36, 31457-40, 31457-46, 31457-50, 31457-55, 31457-60, 31652-100, 31652-105, 31652-110, 31652-115, 31652-120, 31652-25, 31652-30, 31652-35, 31652-40, 31652-45, 31652-55, 31652-60, 31652-65, 31652-70, 31652-75, 31
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
|
FDA
Z-1599-2026
|
Medical Device |
High |
Apr 1, 2026
Recall: Jan 23, 2026
|
Details |
|
|
FDA
Z-1626-2026
|
Medical Device |
High |
Apr 1, 2026
Recall: Sep 5, 2025
|
Details |
|
|
FDA
Z-1597-2026
|
Medical Device |
High |
Apr 1, 2026
Recall: Jan 23, 2026
|
Details |
|
|
FDA
Z-1566-2026
|
Medical Device |
High |
Apr 1, 2026
Recall: Feb 12, 2026
|
Details |
FLS - Foot Locking Plates System and HOL - Hallux Osteotomy Locking Plate with the below descriptions and corresponding article numbers. 1. FLS - Foot Locking Plates System, Cancellous Stabilization Screw; Article Numbers: 37303-10, 37303-12, 37303-14, 37303-16, 37303-18, 37303-20, 37303-22, 37303-24, 37303-26, 37303-28, 37303-30. 2. FLS - Foot Locking Plates System, Cortical Screw; Article Numbers: 32271-10, 32271-12, 32271-14, 32271-16, 32271-18, 32271-20, 32271-22, 32271-24, 32271-26, 32271-28, 32271-32, 32271-34. 3. FLS - Foot Locking Plates System, Cortical Stabilization Screw; Article Nu
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
|
FDA
Z-1605-2026
|
Medical Device |
High |
Apr 1, 2026
Recall: Jan 23, 2026
|
Details |
|
|
FDA
Z-1616-2026
|
Medical Device |
High |
Apr 1, 2026
Recall: Mar 2, 2026
|
Details |
|
|
FDA
Z-1617-2026
|
Medical Device |
High |
Apr 1, 2026
Recall: Mar 2, 2026
|
Details |