Browse recalls
Alert level: Class II
- 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 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 II
IQon Spectral CT IQon Spectral CT Upgrades - 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 II
Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000 Ingenuity Premium Ingenuity CT Upgrades Ingenuity CT - 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 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 II
FARADRIVE STEERABLE SHEATH (CLEAR) - US, used to facilitate access to the vasculature and into the chambers of the heart - 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 - 2026-06-08 · US FDA — Medical DevicesClass II
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Part Number AMS10411B; 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. NON MB DAVI - 2026-06-08 · US FDA — Medical DevicesClass II
Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons. DAVINCI PRO - 2026-06-08 · US FDA — Medical DevicesClass II
Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons. RR-DAVINCI - 2026-06-08 · US FDA — Medical DevicesClass II
Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons. SM-LAPAROSC - 2026-06-08 · US FDA — Medical DevicesClass II
Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons. PROSTATE RO - 2026-06-08 · US FDA — Medical DevicesClass II
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Laminectomy Pack, Pack Number AMS13574A; 2) A - 2026-06-05 · US FDA — Medical DevicesClass II
Optima XR200amx, Mobile Digital-Ready Radiographic System - 2026-06-05 · US FDA — Medical DevicesClass II
Optima XR220amx, Mobile Digital-Ready Radiographic System - 2026-06-05 · US FDA — Medical DevicesClass II
Optima XR240amx, Mobile Digital Radiographic System - 2026-06-05 · US FDA — Medical DevicesClass II
OmniTract Surgical Retractor System, which includes 633 of the firm s product codes. - 2026-06-02 · US FDA — Medical DevicesClass II
The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000; UDI 00607567700406) is a sterile, single-use - 2026-05-29 · US FDA — Medical DevicesClass II
Emano Flow with software version v2.0.0 GS1 GTIN code: 199874903484 Emano Flow is a smartphone-based acoustic uroflo - 2026-05-28 · US FDA — Medical DevicesClass II
Medline Convenience kits containing recalled Swan-Ganz Catheters KIT GERMANTOWN CABG DYNJ905855 KIT UNIVERSITY - 2026-05-28 · US FDA — Medical DevicesClass II
Medline Convenience kits containing recalled Swan-Ganz Catheters CARDIAC MAJOR DYNJ901328G HEART A DYNJ903 - 2026-05-28 · US FDA — Medical DevicesClass II
Medline Convenience kits containing recalled Swan-Ganz Catheters OPEN HEART DYNJ909090B OPEN HEART CDS QVH C - 2026-05-28 · US FDA — Medical DevicesClass II
Medline Convenience kits containing recalled Swan-Ganz Catheters CENTRAL AND ARTERIAL LINE TOTE DYNJ8407 - 2026-05-28 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) ANESTHESIA KIT PEDS 90-LF, Model Number: DYNJAP10125A - 2026-05-28 · US FDA — Medical DevicesClass II
Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH PACK CTX DYNJ68530A - 2026-05-28 · US FDA — Medical DevicesClass II
Medline Convenience kits containing recalled Swan-Ganz Catheters CABG A CDS CDS982269K CDS982269L CDS982269M - 2026-05-28 · US FDA — Medical DevicesClass II
Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH PACK CTX DYNJ68530B - 2026-05-28 · US FDA — Medical DevicesClass II
Medline Convenience kits containing recalled Swan-Ganz Catheters CV ANESTHESIA - ROOM SET UP DYNJ905503D DYNJ905 - 2026-05-28 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569; 2) OPEN HEART PEDS PACK, Model Number: DY - 2026-05-28 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569D; 2) ACCESSORY KIT, Model Number: DYNJ9013 - 2026-05-27 · US FDA — Medical DevicesClass II
Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit, Catalog number 504600-28 - 2026-05-27 · US FDA — Medical DevicesClass II
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 US Retail Sensor/Transmitter 1-pack - 2026-05-27 · US FDA — Medical DevicesClass II
MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896 - 2026-05-22 · US FDA — Medical DevicesClass II
Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System - 2026-05-21 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) SUTURE TRAY, Model Number: SUT12260; 2) CHEST TUBE INSERTION TRAY, Model Number: MNS3390 - 2026-05-21 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) STD, INTRO-FLEX INTRODUCER 6F, C, Model Number: I550BF6C; 2) STD, INTRO-FLEX INTRODUCER - 2026-05-21 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) IMAGING BIOPSY TRAY, Model Number: DYNDH1068; 2) BREAST BIOPSY PACK, Model Number: PHS23 - 2026-05-21 · US FDA — Medical DevicesClass II
GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 00055415010 00055430010 00055430011 - 2026-05-21 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) PI CVC KIT 3L 7 FR 16 CM, Model Number: ECVC8520; 2) NO CATH CENTRAL LINE KIT, Model Numbe - 2026-05-21 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) SUTURING SET, Model Number: SUT13710 - 2026-05-21 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) DYNJ0621189X, Model Number: SM RADIOLOGY-ANGIO PACK-LF; 2) PAIN1470A, Model Number: CONT - 2026-05-21 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) PAIN MGMT/ PREF W. MED NDL, Model Number: PAIN0072L; 2) CONTINUOUS EPIDURAL TRAY, Model Nu - 2026-05-21 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) ARTERIAL ACCESS TRAY W/LIDOCAINE, Model Number: ART1145; 2) Universal Central/Art Line I - 2026-05-21 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) LUMBAR PUNCTURE CHOICE, Model Number: DYNDH1215 - 2026-05-21 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) BLOCK TRAY, Model Number: DYNJRA1590 - 2026-05-21 · US FDA — Medical DevicesClass II
GEM Premier 7000 with iQM3 Part Numbers: 00077407508 00077407510 00077415004 00077415008 00077415010 0007743