April 29, 2026Medical DevicesFDA
ARROW INTERNATIONAL, LLC recalls Arrowg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-21142-DMC UDI code
Hazard: Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
April 29, 2026Medical DevicesFDA
ARROW INTERNATIONAL, LLC recalls MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-11142-LC2 UDI code: (01)10801902206
Hazard: Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
April 29, 2026Medical DevicesFDA
ARROW INTERNATIONAL, LLC recalls Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC Kit REF ASK-45854-PUPM1 UDI code: (01)10801902159578(17)270531
Hazard: Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
April 29, 2026Medical DevicesFDA
ARROW INTERNATIONAL, LLC recalls ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER REF ASK-42802-PLH UDI code:
Hazard: Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
April 29, 2026Medical DevicesFDA
ARROW INTERNATIONAL, LLC recalls FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET REF ASK-05502-BSM UDI code:
Hazard: Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
April 29, 2026Medical DevicesFDA
ARROW INTERNATIONAL, LLC recalls PERCUTANEOUS SHEATH INTRODUCER with 7.5 - 8 Fr. Catheter REF ASK-09903-MGH3 UDI code: (01)10801902159127(17)270331(11)2
Hazard: Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
April 29, 2026Medical DevicesFDA
ARROW INTERNATIONAL, LLC recalls ARROW RADIAL ARTERY CATHETERIZATION KIT REF ASK-04220-UCL1 UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J
Hazard: Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
April 29, 2026Medical DevicesFDA
ARROW INTERNATIONAL, LLC recalls Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 UDI code: (01)10801902220315(17)261231(11)251210(10)33F25J0347
Hazard: Due to receiving a notice from a supplier that the liquid adhesive were incorrectly manufactured
April 29, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2330.
Hazard: Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
April 29, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138.
Hazard: Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
April 29, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2119.
Hazard: Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
April 29, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2118.
Hazard: Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
April 29, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2117.
Hazard: Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
April 29, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116.
Hazard: Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
April 29, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115.
Hazard: XXX
April 29, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2114.
Hazard: Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
April 29, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113.
Hazard: Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
April 29, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112
Hazard: Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
April 29, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2111
Hazard: Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
April 29, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2110. May be included with the Olympus OE
Hazard: Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
April 29, 2026Medical DevicesFDA
XTANT Medical Holdings, Inc recalls nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus Advanced Bone Graft Substitute 90-300-251008: nanOss 3D Adva
Hazard: Products were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life is four years.
April 29, 2026Medical DevicesFDA
Davol, Inc. recalls Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog Number: 1050030.
Hazard: Potential for product to contain foreign matter, confirmed to be inspect fragments.
April 29, 2026Medical DevicesFDA
Magellan Diagnostics, Inc. recalls LeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare Ultra kit is provided with the following mat
Hazard: Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems. False positive lead results may cause delayed results and additional unnecessary testing.
April 29, 2026Medical DevicesFDA
Magellan Diagnostics, Inc. recalls LeadCare¿ Plus Blood Lead Test Kit; Catalog Number: 82-0004; The LeadCare¿ Plus kit is provided with the following mat
Hazard: Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems. False positive lead results may cause delayed results and additional unnecessary testing.
April 29, 2026Medical DevicesFDA
Magellan Diagnostics, Inc. recalls (1)(2) LeadCare¿ II Blood Lead Test Kit, (3)LeadCare¿ II 5X Blood Lead Test Kit, (4)LeadCare¿ II 9X Blood Lead Test Kit
Hazard: Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems. False positive lead results may cause delayed results and additional unnecessary testing.
April 29, 2026Medical DevicesFDA
Medline Industries, LP recalls Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ENSEMBLE GYNECO SCOPIE-LF DYNJ
Hazard: Unapproved design changes to the products outside of the 510(k) clearance.
April 29, 2026Medical DevicesFDA
Medline Industries, LP recalls Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ARTERIOGRAM TRAY 00-402001T, 0
Hazard: Unapproved design changes to the products outside of the 510(k) clearance.
April 29, 2026Medical DevicesFDA
Medline Industries, LP recalls Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ADD A ENDOVASCULAR PACK-LF DYN
Hazard: Unapproved design changes to the products outside of the 510(k) clearance.
April 29, 2026Medical DevicesFDA
Medline Industries, LP recalls Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes E P DRAPE PACK-LF DYNJ0373061J
Hazard: Unapproved design changes to the products outside of the 510(k) clearance.
April 29, 2026Medical DevicesFDA
Medline Industries, LP recalls Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ARTHROSCOPY PACK DYNJ45173D
Hazard: Unapproved design changes to the products outside of the 510(k) clearance.