Browse recalls
Issuing authority: US FDA — Medical Devices
- 2026-07-13 · US FDA — Medical DevicesClass II
MiniMed 780G Insulin Pump, Model: MMT-1885CLW, MMT-1886CLW - 2026-07-13 · US FDA — Medical DevicesClass II
MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782; - 2026-07-13 · US FDA — Medical DevicesClass II
Medline breathing circuits labeled as: 1) MEDLINE HUDSON RCI, CIRCUIT, NEO, SING LIMB, HTD,COLUMN, Medline Product Nu - 2026-07-13 · US FDA — Medical DevicesClass II
MiniMed 640G Insulin Pump, Model: MMT-1711, MMT-1712; - 2026-07-13 · US FDA — Medical DevicesClass II
GM Helix Implant, Endosseous Dental Implant Article No. 109.984 - 2026-07-08 · US FDA — Medical DevicesClass II
TD Navio Midi Speech Generating Device Model/Catalog Number: 1000798 - 2026-07-08 · US FDA — Medical DevicesClass II
TD Navio Maxi Speech Generating Device Model/Catalog Number: 1000799 - 2026-07-06 · US FDA — Medical DevicesClass II
Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic - 2026-07-06 · US FDA — Medical DevicesClass I
Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule Model/Cat - 2026-07-06 · US FDA — Medical DevicesClass II
Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16 - 2026-07-02 · US FDA — Medical DevicesClass II
OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17.5 mm (IsoTis Brand), REF: 02-8000-095 - 2026-06-30 · US FDA — Medical DevicesClass II
Rapid Refill Continuous Injection System, UPN M00566001 - 2026-06-30 · US FDA — Medical DevicesClass II
SnapshotGLO Wound Imaging Device, Model KB100, KB100AA. - 2026-06-30 · US FDA — Medical DevicesClass II
Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count Bag, Product Number MSC351450BG4 - 2026-06-30 · US FDA — Medical DevicesClass II
Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count, Product Number MSC351450AN - 2026-06-30 · US FDA — Medical DevicesClass II
Medline Micro-Kill Bleach Germicidal Bleach Wipes, 6" x 5", 150 count, Product Number MSC351410AN - 2026-06-30 · US FDA — Medical DevicesClass II
Medline Micro-Kill Bleach Germicidal Bleach Wipes,7" x 8", 150 count, 150 count, Product Number MSC351400AN - 2026-06-29 · US FDA — Medical DevicesClass II
GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph - 2026-06-29 · US FDA — Medical DevicesClass II
Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP - 2026-06-26 · US FDA — Medical DevicesClass III
Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL - 2026-06-26 · US FDA — Medical DevicesClass II
ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000 - 2026-06-26 · US FDA — Medical DevicesClass III
Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL - 2026-06-25 · US FDA — Medical DevicesClass II
Brand Name: Quantum Rehab Product Name: Q6 Edge 3 Stretto Model/Catalog Number: Q6 Edge 3 Stretto Software Version: 2 - 2026-06-25 · US FDA — Medical DevicesClass II
Brand Name: Quantum Rehab Product Name: Quantum Outback Model/Catalog Number: Quantum Outback Software Version: 2.0.1 - 2026-06-25 · US FDA — Medical DevicesClass II
Brand Name: Quantum Rehab Product Name: Quantum 4Front 2 Model/Catalog Number: Quantum 4Front 2 Software Version: 2.0 - 2026-06-25 · US FDA — Medical DevicesClass II
Brand Name: Quantum Rehab Product Name: 4Front Model/Catalog Number: 4Front Software Version: 2.0.11, new version: 2. - 2026-06-25 · US FDA — Medical DevicesClass II
Brand Name: Quantum Rehab Product Name: Quantum 1450 Model/Catalog Number: Quantum 1450 Software Version: 2.0.11, new - 2026-06-25 · US FDA — Medical DevicesClass II
Brand Name: Quantum Rehab Product Name: Q6 Edge HD Model/Catalog Number: Q6 Edge HD Software Version: 2.0.11, new ver - 2026-06-25 · US FDA — Medical DevicesClass II
Brand Name: Quantum Rehab Product Name: Quantum Rival Model/Catalog Number: Quantum Rival Software Version: 2.0.11, n - 2026-06-25 · US FDA — Medical DevicesClass II
Brand Name: Quantum Rehab Product Name: R-TRAK Model/Catalog Number: R-TRAK Software Version: 2.0.11, new version: 2. - 2026-06-25 · US FDA — Medical DevicesClass II
Brand Name: Quantum Rehab Product Name: Q6 Edge 3 Model/Catalog Number: Q6 Edge 3 Software Version: 2.0.11, new versi - 2026-06-25 · US FDA — Medical DevicesClass II
Brand Name: Quantum rehab Product Name: Q6 Edge 2.0 Model/Catalog Number: Q6 Edge 2.0 Software Version: 2.0.11, new v - 2026-06-25 · US FDA — Medical DevicesClass II
Brand Name: Quantum Rehab Product Name: Q6 Edge 4 Model/Catalog Number: Q6 Edge 4 Software Version: 2.0.11, new versi - 2026-06-25 · US FDA — Medical DevicesClass II
Brand Name: Quantum Rehab Product Name: Q6 Edge 2.0 (ilevel) Model/Catalog Number: Q6 Edge 2.0 (ilevel) Software Vers - 2026-06-25 · US FDA — Medical DevicesClass II
Brand Name: Quantum Rehab Product Name: Quantum 4Front 2HD Model/Catalog Number: Quantum 4Front 2HD Software Version: - 2026-06-23 · US FDA — Medical DevicesClass II
Charger for the Therabody Theragun, G4 PRO massage device, and products which include the 4th Generation Theragun PRO ch - 2026-06-19 · US FDA — Medical DevicesClass II
munevo DRIVE and munevo DRIVE r-net Powered Wheelchair Hands-Free Control Application/Smart Glasses Interface/Wheelch - 2026-06-19 · US FDA — Medical DevicesClass II
Power F2 Powered Fastening System, Product No. 0567091 Powered fastening system intended for professional use only. De - 2026-06-19 · US FDA — Medical DevicesClass II
Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing Sys - 2026-06-17 · US FDA — Medical DevicesClass I
INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INFINION CX LEAD KIT, 70CM, Model: SC-2317-70, - 2026-06-17 · US FDA — Medical DevicesClass II
Ventriculostomy Kit, REF: 46154 - 2026-06-16 · US FDA — Medical DevicesClass II
Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator - 2026-06-16 · US FDA — Medical DevicesClass II
Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator - 2026-06-16 · US FDA — Medical DevicesClass II
MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android) - 2026-06-15 · US FDA — Medical DevicesClass II
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO2010 Software Version: N/A Pr - 2026-06-15 · US FDA — Medical DevicesClass II
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO4010 Software Version: N/A Pr - 2026-06-15 · US FDA — Medical DevicesClass II
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO5010 Software Version: N/A Pr - 2026-06-15 · US FDA — Medical DevicesClass II
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO2075 Software Version: N/A Pr - 2026-06-15 · US FDA — Medical DevicesClass II
Brand Name: COAPTIUM Connect Product Name: COAPTIUM Connect Model/Catalog Number: NCOCO1510 Software Version: N/A Pr - 2026-06-15 · US FDA — Medical DevicesClass II
L-Cath Midline S/L Catheter 20ga (3F) 1mm x 20cm, REF: 384620 - 2026-06-15 · US FDA — Medical DevicesClass II
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO1575 Software Version: N/A Pr - 2026-06-15 · US FDA — Medical DevicesClass II
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO6010 Software Version: N/A Pr - 2026-06-15 · US FDA — Medical DevicesClass II
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO3010 Software Version: N/A Pr - 2026-06-15 · US FDA — Medical DevicesClass II
L-Cath PICC S/L Peripherally Inserted Central Catheter: 26ga (1.9F) 0.60mm x 30cm, REF: 384539; 18ga (3.5F) 1.15mm x 60c - 2026-06-12 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) BLOOD CULTURE TRAY PEDIATRIC, Model Number: DYNDH1193; 2) BLOOD CULTURE KIT 2 W/CONNECT, - 2026-06-12 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) DYKM1414, Catalog Number: DYKM1414; 2) DYKM1414, Catalog Number: DYKM1414; 3) DYNDH146 - 2026-06-12 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) ULTRASOUND BREAST PACK, Model Number: DYNJ63375C - 2026-06-12 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) LABOR CDS, Model Number: CDS981762B; 2) VAG DELIVERY ADMISSION BAG, Model Number: DYKA10 - 2026-06-12 · US FDA — Medical DevicesClass II
ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum o - 2026-06-12 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) C-SECTION PREP, Model Number: DYNJ32702B - 2026-06-12 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) IV START KIT LAB DRAW-SH, Model Number: CDS860014P; 2) IV START KIT, Model Number: DYKM1 - 2026-06-12 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) EYE KIT, Model Number: DYKM2751; 2) EYE KIT, Model Number: DYKM2751A; 3) CATARACT PREO - 2026-06-12 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) IV START KIT, Catalog Number: DYNDV2520; 2) PERIPHERAL LAB BLOOD CULTURE KIT, Catalog Nu - 2026-06-12 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) CDS840396X, Catalog Number: CDS840396X; 2) CDS840396Y, Catalog Number: CDS840396Y; 3) - 2026-06-12 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) IVS BLOOD CULTURE KIT, Model Number: DYNDH1920; 2) IVS BLOOD CULTURE KIT, Model Number: - 2026-06-12 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) DRAWER 9 CRICOTHYROTOMY KIT, Model Number: ACC010741; 2) KIT ANESTHESIA L&D A- LINE SET, - 2026-06-12 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) PRE-OP KIT, Catalog Number: DYKS1043F; 2) PRE OP KIT, Catalog Number: DYKS1128C; 3) PR - 2026-06-12 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) COLORECTAL ME, Model Number: DYNJ906437D - 2026-06-12 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) ARTERIAL LINE INSERTION KIT, Model Number: ART1295 - 2026-06-12 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) ORTHO ASPIRATION KIT, Model Number: DYKM1636A; 2) SHOULD BLOCK KIT, Model Number: DYKM18 - 2026-06-12 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) BLOOD DRAW KIT, Catalog Number: DYLAB1081; 2) WHOLE BLOOD PHLEBOTOMY KIT, Catalog Number - 2026-06-11 · US FDA — Medical DevicesClass II
FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Mater - 2026-06-11 · US FDA — Medical DevicesClass I
ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 Fr, 13 cm & 25 cm, Product Cod - 2026-06-11 · US FDA — Medical DevicesClass I
ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, containing Kit, 14Fr Introducer, 13cm, Long Tap - 2026-06-11 · US FDA — Medical DevicesClass I
ABIOMED Impella CP Introducer Kit 14 Fr, 13 and 25 cm, Pump Set Code 1000550, containing Kit, 14Fr Introducer, 13cm&25cm - 2026-06-11 · US FDA — Medical DevicesClass II
IQon Spectral CT IQon Spectral CT Upgrades - 2026-06-11 · US FDA — Medical DevicesClass I
ABIOMED Insertion Kit, Pkgd, JP, Pump Set Code 0052-0011-JP; containing Introducer Product Code 0052-3006-JP. heart pum - 2026-06-11 · US FDA — Medical DevicesClass II
Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel CT6000 Brilliance 64 Upgrades - 2026-06-11 · US FDA — Medical DevicesClass I
ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product Code 0052-3046. heart pump and accessori - 2026-06-11 · US FDA — Medical DevicesClass I
ABIOMED Impella CP Introducer Kit 14 Fr, 25 cm, Pump Set Code 0052-0039, containing Kit, 14Fr Introducer, 25cm, Long Tap - 2026-06-11 · US FDA — Medical DevicesClass I
ABIOMED Impella 5.5 SmartAssist S2 Set, JP, Pump Set Codes 1000459, 1000460; containing Introducer Product Code 0052-300 - 2026-06-11 · US FDA — Medical DevicesClass II
Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000 Ingenuity Premium Ingenuity CT Upgrades Ingenuity CT - 2026-06-11 · US FDA — Medical DevicesClass I
ABIOMED Impella RP Flex with SmartAssist Set, Pump Set Code 1000323, containing Kit, 23Fr Introducer, 11cm, Sterile, 23 - 2026-06-11 · US FDA — Medical DevicesClass II
FARADRIVE STEERABLE SHEATH CLEAR OUS, used to facilitate access to the vasculature and into the chambers of the heart, M - 2026-06-11 · US FDA — Medical DevicesClass I
ABIOMED Impella CP Set, Pump Set Code 0048-0044; containing Introducer Product Code 0052-3046. heart pump and accessori - 2026-06-11 · US FDA — Medical DevicesClass I
ABIOMED Impella 5.5 Smart Assist Set, JP, Pump Set Codes 1000211, 1000212; containing Introducer Product Code 0052-3006- - 2026-06-11 · US FDA — Medical DevicesClass II
FARADRIVE Steerable Sheath Clear IDE, used to facilitate access to the vasculature and into the chambers of the heart, M - 2026-06-11 · US FDA — Medical DevicesClass I
ABIOMED Intro Kit, 14Fr x 13 and 25 cm, PKGD, JP, Pump Set Code 0052-0023-JP; containing Introducer Product Code 0052-30 - 2026-06-11 · US FDA — Medical DevicesClass I
ABIOMED Impella CP Smart Assist Set, JP, Pump Set Code 0048-0024-JP; containing Introducer Product Code 0052-3025-JP. h - 2026-06-11 · US FDA — Medical DevicesClass II
FARADRIVE STEERABLE SHEATH (CLEAR) - US, used to facilitate access to the vasculature and into the chambers of the heart - 2026-06-11 · US FDA — Medical DevicesClass I
ABIOMED Introducer Kit 23 Fr, 11 cm, Pump Set Code 1000441, containing Kit, 23Fr Introducer, 11cm, Sterile, Introducer P - 2026-06-10 · US FDA — Medical DevicesClass II
Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK DYNJT6267 - 2026-06-10 · US FDA — Medical DevicesClass II
Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK-LF DYNJ61651J - 2026-06-08 · US FDA — Medical DevicesClass II
Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons. ROBOTIC - 2026-06-08 · US FDA — Medical DevicesClass II
Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons. UROLOGY - 2026-06-08 · US FDA — Medical DevicesClass II
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Pack Number AMS12206; 2) ENT Pack, - 2026-06-08 · US FDA — Medical DevicesClass II
Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons. KIT ROBOTIC - 2026-06-08 · US FDA — Medical DevicesClass II
HardyDisk AST Cefiderocol 30µg (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30µg (FDC30) for in vitro agar diffusion - 2026-06-08 · US FDA — Medical DevicesClass II
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Neuro Pack, Pack Number AMS12195C; 2) Neuro P - 2026-06-08 · US FDA — Medical DevicesClass II
Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons. KIT ROBOTIC