April 1, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.
Hazard: The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
April 1, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444.
Hazard: The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
April 1, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.
Hazard: The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
April 1, 2026Medical DevicesFDA
Beckman Coulter, Inc. recalls MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 MicroScan panels are designed for use in determining ant
Hazard: Due to the likely presence of contamination in well(s).
April 1, 2026Medical DevicesFDA
I.T.S. GmbH recalls Brand Name: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) with the below descriptions and corresponding art
Hazard: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
April 1, 2026Medical DevicesFDA
I.T.S. GmbH recalls HLS - Hand Locking Plates System with the below descriptions and corresponding article numbers. 1. Cortical Screw; A
Hazard: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
April 1, 2026Medical DevicesFDA
I.T.S. GmbH recalls HCS - Headless Compression Screw System, Headless Compression Screw, Cannulated; Article Numbers: 31207-10, 31207-12, 31
Hazard: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
April 1, 2026Medical DevicesFDA
I.T.S. GmbH recalls FLS - Foot Locking Plates System and HOL - Hallux Osteotomy Locking Plate with the below descriptions and corresponding
Hazard: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
April 1, 2026Medical DevicesFDA
I.T.S. GmbH recalls I.T.S. DUL (Distal Ulna Locking) System and UOL (Ulna Osteotomy Locking) System with the below descriptions and correspo
Hazard: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
April 1, 2026Medical DevicesFDA
I.T.S. GmbH recalls I.T.S. LRS (Locking Reconstruction System) with the below descriptions and corresponding article numbers. 1. DFL (Di
Hazard: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
April 1, 2026Medical DevicesFDA
I.T.S. GmbH recalls Distal Humeral Plates with Angular Stability with the below descriptions and corresponding article numbers. 1. Corti
Hazard: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
April 1, 2026Medical DevicesFDA
I.T.S. GmbH recalls I.T.S. Fibula Plate PROlock with Angular Stability with the below descriptions and corresponding article numbers. 1.
Hazard: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
April 1, 2026Medical DevicesFDA
I.T.S. GmbH recalls Pelvic Reconstruction System (PRS) with the below descriptions and corresponding article numbers. 1. Fixation Screw;
Hazard: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
April 1, 2026Medical DevicesFDA
I.T.S. GmbH recalls I.T.S. Screw System with the below descriptions and corresponding article numbers. 1. Cancellous Screw, Cannulated;
Hazard: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
April 1, 2026Medical DevicesFDA
I.T.S. GmbH recalls I.T.S. Straight Plate with Angular Stability with the below descriptions and corresponding article numbers. 1. Forea
Hazard: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
April 1, 2026Medical DevicesFDA
I.T.S. GmbH recalls Olecranonplate with Angular Stability with the below descriptions and corresponding article numbers. 1. Olecranon Hoo
Hazard: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
April 1, 2026Medical DevicesFDA
I.T.S. GmbH recalls Pilonplate with Angular Stability, with the below descriptions and corresponding article numbers. 1. Anterolateral T
Hazard: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
April 1, 2026Medical DevicesFDA
I.T.S. GmbH recalls FR.O.H. Calcaneus Repair System with the following description: Anterolateral Calcaneus Plate. Article Number: 21064-60.
Hazard: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
April 1, 2026Medical DevicesFDA
I.T.S. GmbH recalls Brand Name: Humeral Head Plate with Angular Stability, with the following description: Proximal Humeral Plate. Article N
Hazard: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
April 1, 2026Medical DevicesFDA
I.T.S. GmbH recalls Claviculaplate with Angular Stability, with the below descriptions and associated article numbers. 1. Anterior Clavi
Hazard: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
April 1, 2026Medical DevicesFDA
I.T.S. GmbH recalls Volar Radius Plate with Angular Stability with the following description: Radius Plate PROlock II. Article Numbers: 2103
Hazard: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
April 1, 2026Medical DevicesFDA
GE Medical Systems, LLC recalls Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E8
Hazard: There is a potential issue that can lead to discordance between the simulated needle trajectory/tip position and the actual needle trajectory/tip position.
April 1, 2026Medical DevicesFDA
Navajo Manufacturing Company recalls Handy Solutions Neck & Shoulders Heating Pad, Number: 25607, Manufactured by Ninbo Unico Products Co., Ltd
Hazard: If heating pad is folded while in use, the power density increases in the folded area causing excessive temperatures, which can also be caused by placing pad under the body, then the high limit device is unable to sense the higher temperature so power is not terminated. May cause a burning smell prior to melting/burning potentially causing burns to persons and property.
April 1, 2026Medical DevicesFDA
Merit Medical Systems, Inc. recalls BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU, H965103028031/A, H965103028031/EU, H96
Hazard: 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.
April 1, 2026Medical DevicesFDA
Merit Medical Systems, Inc. recalls DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A, H787103028025/A, H787103028031/A, H787103028035/A, H7871030
Hazard: 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.
April 1, 2026Medical DevicesFDA
Merit Medical Systems, Inc. recalls 16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/B
Hazard: 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.
April 1, 2026Medical DevicesFDA
Merit Medical Systems, Inc. recalls ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-NE5/C, DC21454035/C,
Hazard: 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.
April 1, 2026Medical DevicesFDA
Merit Medical Systems, Inc. recalls CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/A, CENFP31K
Hazard: 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.
April 1, 2026Medical DevicesFDA
Erbe USA Inc recalls Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use
Hazard: Probes may rupture/burst during activation
April 1, 2026Medical DevicesFDA
Erbe USA Inc recalls Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical use
Hazard: Probes may rupture/burst during activation