Browse recalls
Issuing authority: US FDA — Medical Devices
- 2026-08-11 · US FDA — Medical DevicesClass II
Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo S with software - 2026-08-11 · US FDA — Medical DevicesClass II
Computed Tomography X-ray System, Model: uCT 780 with software - 2026-08-11 · US FDA — Medical DevicesClass II
Computed Tomography X-ray System, Model: uCT ATLAS with software - 2026-08-11 · US FDA — Medical DevicesClass II
Computed Tomography X-ray System, Model: uCT ATLAS Astound with software - 2026-08-11 · US FDA — Medical DevicesClass II
Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo with software - 2026-08-11 · US FDA — Medical DevicesClass II
Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama GS with software - 2026-08-11 · US FDA — Medical DevicesClass II
Computed Tomography X-ray System, Model: uCT 760 with software - 2026-08-11 · US FDA — Medical DevicesClass II
Positron Emission Tomography and Computed Tomography System, Model: uMI 550 with software - 2026-08-11 · US FDA — Medical DevicesClass II
Positron Emission Tomography and Computed Tomography System, Model: uMI 780 - 2026-08-10 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) ANTERIOR SPINE PACK, Catalog Number: DYNJT10197; 2) CRANIOTOMY #IMF 56646-LF, Catalog Nu - 2026-08-10 · US FDA — Medical DevicesClass II
Presource Convenience Kits: 1) KIT, PRE OP , Catalog Number: AMN548616A; 2) KIT, NICU ADMIT NEW HAN - 2026-08-10 · US FDA — Medical DevicesClass II
Presource Convenience Kits: 1) KIT, USGPIV , Catalog Number: PVMHIVMHD; 2) KIT, USGPIV - 2026-08-10 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) MAJOR NEURO VCH, Catalog Number: DYNJ39218I; 2) NEURO PACK-LF, Catalog Number: DYNJ41246 - 2026-08-10 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) MFC CRANIOTOMY PACK, Catalog Number: DYNJT8784; 2) SLUH CRANIOTOMY PACK-LF, Catalog Numb - 2026-08-10 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) PEDS SINUS PACK, Catalog Number: DYNJ02516G; 2) SINUS PACK-LF, Catalog Number: DYNJ03427 - 2026-08-10 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) MAJOR PACK, Catalog Number: DYNJ81325A - 2026-08-10 · US FDA — Medical DevicesClass II
Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays ABDOMINAL HYSTERECT - 2026-08-10 · US FDA — Medical DevicesClass II
Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays CARDIAC HEART BUNDL - 2026-08-10 · US FDA — Medical DevicesClass II
Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays ROBOTIC PACK - 2425 - 2026-08-06 · US FDA — Medical DevicesClass II
ORT200, operating room table, including the ORT200 Covered Table Assembly, Reconditioned, Part Number 113821-600 and the - 2026-08-06 · US FDA — Medical DevicesClass II
ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers 114093-000 and 114093-600 - 2026-08-06 · US FDA — Medical DevicesClass II
LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS US, Model Number 7260, All Ver - 2026-08-06 · US FDA — Medical DevicesClass II
LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS ANZ, Model Number 7248, All Ve - 2026-08-06 · US FDA — Medical DevicesClass II
LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS EU, Model Number 7246, All Ver - 2026-08-06 · US FDA — Medical DevicesClass I
Bravo CF capsule delivery device, 5-pack, Product Number FGS-0635, Bravo CF capsule delivery device, 1-pack, Product - 2026-08-06 · US FDA — Medical DevicesClass II
Brand Name: Heidelberg Engineering GmbH Product Name: SPECTRALIS with Flex Module Model/Catalog Number: S3610, S2610, - 2026-08-04 · US FDA — Medical DevicesClass II
Brand Name: VERIQA; Product Name: RT MonteCarlo 3D v3; Model/Catalog Number: S070031.520; Software Version: 3.1.18; - 2026-08-03 · US FDA — Medical DevicesClass II
Systems/units containing affected software/SQL BECKMAN COULTER CHEMISTRY ANALYZER AU480 REF / UDI-DI code: B96692 / 1 - 2026-07-31 · US FDA — Medical DevicesClass II
HEALON EndoCoat PRO, REF: 10300012 (US/CAN) HEALON DUET PRO II, REF: 10300016 (US/CAN) HEALON EndoCoat PRO, REF: 10 - 2026-07-31 · US FDA — Medical DevicesClass II
Centricity PACS Server V7, intended for managing digital medical images and associated data, All versions - 2026-07-31 · US FDA — Medical DevicesClass II
Centricity PACS V2, V3, V4, V6, V7, software product is intended for the storage, reading, diagnostic review, analysis, - 2026-07-31 · US FDA — Medical DevicesClass II
Centricity Enterprise Archive V2, V3, and V4, software product for receiving, archiving, and sending electronic medical - 2026-07-31 · US FDA — Medical DevicesClass II
Core Services Hub V8, a set of backend services including Cross Enterprise (XE) and Workflow Core (WFC) services that en - 2026-07-31 · US FDA — Medical DevicesClass II
Workflow Core Services V8, intended to provide set of services for storage and retrieval of patient data, exams and perf - 2026-07-31 · US FDA — Medical DevicesClass II
Enterprise Archive V8, software product for receiving, archiving, and sending electronic medical data, All versions - 2026-07-30 · US FDA — Medical DevicesClass I
BD Needle Kit for Powered Driver 15mm x 15Ga, REF: D015151NK, BD Needle Kit for Powered Driver 25mm x 15Ga, REF: D01525 - 2026-07-30 · US FDA — Medical DevicesClass II
Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000 - 2026-07-30 · US FDA — Medical DevicesClass II
Et Control, Software option for anesthesia gas machine to achieve and maintain targeted end tidal oxygen and anesthetic - 2026-07-30 · US FDA — Medical DevicesClass II
Aisys CS2, Datex-Ohmeda anesthesia system, Part Number 1011-9055-000 - 2026-07-30 · US FDA — Medical DevicesClass II
SCORPIO C-DOME PATELLA 73-2710 73-2910 SCORPIO U-DOME PATELLA 73-3110 73-3508 73-3708 73-3710 73-391 - 2026-07-30 · US FDA — Medical DevicesClass II
ABG I ACETABULAR INSERT HOODED 28mm ID X 48mm C-M079-2-801 ARC2F ACETABULAR INSERT 48/50/52mm OD x 28mm ID - 2026-07-30 · US FDA — Medical DevicesClass II
ACETABULAR CUP UHMWPE 61-3258 ALL POLY CONSTRAINED INSERT 44MM 69-2244 ALL POLY CONSTRAINED INSERT 46MM - 2026-07-30 · US FDA — Medical DevicesClass II
OMNIFIT SERIES I ACET. INSERT 10 22mm ID Catalog No. 2001-2246 Orthopaedic implant components manufactured from - 2026-07-30 · US FDA — Medical DevicesClass II
TRIDENT 0 POLY INSERT 28mm ID 620-00-28D Orthopaedic implant components manufactured from UHMWPE (polyethylene) - 2026-07-30 · US FDA — Medical DevicesClass II
ALL POLY CONSTRAINED INSERT 54MM 69-2854 NRG KNEE CR 82-2-0512 82-2-0518 82-2-0912 NRG KNEE P/S 82- - 2026-07-30 · US FDA — Medical DevicesClass II
DURACON XL ANGLED TIB INS 11/14MM C-M064-1-300 SELF-PRESSURIZING GLENOID SIZE 8 C-M062-6-800 C-M062-7-500 - 2026-07-30 · US FDA — Medical DevicesClass II
SCORPIO + MOBILE BEARING PCS 78-5-0910 SYSTEM ONE BIPOLAR 40MM 6074-4022 SYSTEM ONE BIPOLAR 43MM 6074-43 - 2026-07-30 · US FDA — Medical DevicesClass II
BEARING AND AXLE BUSHING ASSY STD ELBOW C-M113-1-301 KRH REV TIB INS 16mm THK .640 DIA STEM C-M113-5-600 S - 2026-07-30 · US FDA — Medical DevicesClass II
SCORPIO RECESSED METAL BACKED PATELLA 3045-0026 3045-0028 3045-0030 3045-0032 Orthopaedic implant compone - 2026-07-30 · US FDA — Medical DevicesClass II
TRIATHLON HINGE INSERT SIZE 4 11MM 5612-P-411 TRIATHLON HINGE INSERT SIZE 4 13MM 5612-P-413 Orthopaed - 2026-07-30 · US FDA — Medical DevicesClass II
Aisys, Datex-Ohmeda anesthesia system, Part Number 1011-9050-000 - 2026-07-30 · US FDA — Medical DevicesClass II
AXLE PIN ASSY LARGE ELBOW COBALT CHROME Catalog No. C-M112-2-500 Orthopaedic implant components manufactured from - 2026-07-29 · US FDA — Medical DevicesClass II
Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) PBCGLVBLI, Catalog Number: KI - 2026-07-29 · US FDA — Medical DevicesClass II
Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, GYN ROBOTIC GSAM - 2026-07-29 · US FDA — Medical DevicesClass II
Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, ROBOTIC HYST - 2026-07-29 · US FDA — Medical DevicesClass II
Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT,MAXILLOFACIAL PRESBYTERIA - 2026-07-29 · US FDA — Medical DevicesClass II
Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, ASLMC CRANIOTOMY - 2026-07-29 · US FDA — Medical DevicesClass II
Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, ENT HARVEST - 2026-07-29 · US FDA — Medical DevicesClass II
Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, CHONY ORTHO MAJOR SPINE - 2026-07-29 · US FDA — Medical DevicesClass II
Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, BLO ROBOTIC GYN - 2026-07-29 · US FDA — Medical DevicesClass II
Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT,ROBOTICS DH - 2026-07-29 · US FDA — Medical DevicesClass II
Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, LUNG TX CIRCULATOR - 2026-07-29 · US FDA — Medical DevicesClass II
Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT,GYN LAPAROSCOPY DH - 2026-07-29 · US FDA — Medical DevicesClass II
Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, GVI OPEN HEART A B - 2026-07-29 · US FDA — Medical DevicesClass I
StatStrip Glucose and B- Ketone meter. Model No: 63910. Glucose test system. - 2026-07-29 · US FDA — Medical DevicesClass I
StatStrip Glucose and B- Ketone meter. Model No: 63683. Glucose test system. - 2026-07-29 · US FDA — Medical DevicesClass I
StatStrip Glucose Hospital Meter System. Model No: 63685. Glucose test system. - 2026-07-29 · US FDA — Medical DevicesClass I
StatStrip Glucose and B- Ketone meter. Model No: 66429. Glucose test system. - 2026-07-29 · US FDA — Medical DevicesClass I
StatStrip Glucose Hospital Meter System. Model No: 66739. Glucose test system. - 2026-07-29 · US FDA — Medical DevicesClass II
Brand Name: VACUETTE Product Name: LH Lithium Heparin Separator Model/Catalog Number: 454008P Product Description: Gr - 2026-07-27 · US FDA — Medical DevicesClass II
Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006 - 2026-07-24 · US FDA — Medical DevicesClass II
VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811 - 2026-07-23 · US FDA — Medical DevicesClass II
Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008N - 2026-07-23 · US FDA — Medical DevicesClass II
Blood Culture Collection Venipuncture Kit 20/Cs, REF: 77451; Blood Culture Kit 20/Cs, REF: 81834B; Blood Culture Colle - 2026-07-20 · US FDA — Medical DevicesClass II
PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353 - 2026-07-20 · US FDA — Medical DevicesClass II
PORTRAIT COMPUTE AND CORE SERVICES V1.2, Ref# 5700592 - 2026-07-20 · US FDA — Medical DevicesClass II
FRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1, Ref# 5700225 - 2026-07-20 · US FDA — Medical DevicesClass II
PORTRAIT CORE SERVICES SOFTWARE V1.1, Ref# 5700209 - 2026-07-20 · US FDA — Medical DevicesClass II
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ADULT BLOOD CULTURE KIT DYNDH1444D BL - 2026-07-20 · US FDA — Medical DevicesClass II
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators CATARACT PREOP KIT DYKS1583A - 2026-07-20 · US FDA — Medical DevicesClass II
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators OPEN HEART CDS983348AA CDS983348AB - 2026-07-20 · US FDA — Medical DevicesClass II
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BLOOD CULTURE PINK PERIPHERAL DYNDV1875 - 2026-07-20 · US FDA — Medical DevicesClass II
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators IV START KIT LAB DRAW-SH CDS860014Q I - 2026-07-20 · US FDA — Medical DevicesClass II
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators PATIENT ADMIN KIT DYKA1384B DYKA1384C - 2026-07-20 · US FDA — Medical DevicesClass II
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BASIN PACK-LF DYNJ42828B EYE BASIN TR - 2026-07-20 · US FDA — Medical DevicesClass II
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators DELUXE PRE OP KIT DYKS2018 GENERAL PR - 2026-07-20 · US FDA — Medical DevicesClass II
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BLOOD CULTURE KIT 2 W/CONNECT DYNDH1487A - 2026-07-20 · US FDA — Medical DevicesClass II
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ORTHO ASPIRATION KIT DYKM1636A - 2026-07-20 · US FDA — Medical DevicesClass II
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators C-SECTION PREP DYNJ32702B - 2026-07-20 · US FDA — Medical DevicesClass II
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators LABOR CDS CDS981762B VAG DELIVERY AD - 2026-07-20 · US FDA — Medical DevicesClass II
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators PAIN PRE OP KIT DYKS1476A - 2026-07-16 · US FDA — Medical DevicesClass II
Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236, with Software Versi - 2026-07-16 · US FDA — Medical DevicesClass II
Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222,722223, 722224, - 2026-07-16 · US FDA — Medical DevicesClass II
Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application, iOS Model/Catalog Number: iOS soft - 2026-07-15 · US FDA — Medical DevicesClass II
Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1.5 or lower: 1) AU w/out ISE, Part Numbe - 2026-07-15 · US FDA — Medical DevicesClass II
Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower: 1) DxC 500 AU Module w/ISE, D - 2026-07-13 · US FDA — Medical DevicesClass II
Medline breathing circuits labeled as: 1) HUDSON RCI, CIRCUIT, HTD, DL, NEONATE, 48, Medline Product Number/SKU HUD780 - 2026-07-13 · US FDA — Medical DevicesClass II
Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23 mL;R2 2x13 mL - 2026-07-13 · US FDA — Medical DevicesClass II
Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL - 2026-07-13 · US FDA — Medical DevicesClass II
Medline Hudson RCI, DBD-CIRCUIT,VENT,INSPIRATORY,HEATED,NEO, Medline Product Number/SKU HUD78019 (Teleflex Product Numbe