Browse recalls
Alert level: Class II
- 2026-05-21 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) OPHTHALMIC PACK W/LIDO, Model Number: DYNJ57922A - 2026-05-21 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) ARTERIAL LINE KIT, Model Number: ART890B; 2) ULTRASOUND GUIDED IV SECUREMENT SET, Model - 2026-05-21 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) MERCY MEDICAL CIRCUMCISION TRAY, Model Number: CIT6780; 2) CIRCUMCISION TRAY W/1.1CM CIR - 2026-05-21 · US FDA — Medical DevicesClass II
Solar GI System (Water Perfusion); Product Name (Catalog Number): Solar GI LGI H2O, 12p, Trolley system (G3-6), Solar - 2026-05-21 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) MULTIMED, 7FR, 20CM, 3L, CVC BUNDLE, Model Number: ECVC5995; 2) TRIPLE LUMEN CENTRAL LIN - 2026-05-21 · US FDA — Medical DevicesClass II
Medline Convenience Kits: 1) L&D CONTINUOUS EPIDURAL TRAY, Model Number: PAIN1699A - 2026-05-19 · US FDA — Medical DevicesClass II
Halyard medical convenience kits labeled as: 1) A-P PACK - 205936, Model/Item Number (kit) ANAP22-01; 2) POSTERIOR - 2026-05-19 · US FDA — Medical DevicesClass II
TRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300. - 2026-05-19 · US FDA — Medical DevicesClass II
American Contract Systems medical procedure kits and trays labeled as: 1) ANTERIOR CERVICAL PACK - 205988, Model Item - 2026-05-19 · US FDA — Medical DevicesClass II
Halyard medical convenience kits labeled as: 1) ENT, Model/Item Number (kit) ACEN89-01; 2) ENT, Model/Item Number ( - 2026-05-19 · US FDA — Medical DevicesClass II
American Contract Systems medical procedure kits and trays labeled as: 1) CRANI PACK - 208400, Model Item Number UDCP - 2026-05-19 · US FDA — Medical DevicesClass II
TRI TS BASEPLATE SIZE 4. Part Number: 5521-B-400. - 2026-05-19 · US FDA — Medical DevicesClass II
1) NEURO, (kit) ACNE73-01; 2) NEURO, (kit) ACNE73-03; 3) CRANI, (kit) AKCR19-01; 4) ORTHO SPINE PACK, (kit) ARMC01 - 2026-05-13 · US FDA — Medical DevicesClass II
SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System - 2026-05-12 · US FDA — Medical DevicesClass II
Octopus Evolution AS Tissue Stabilizer, Model TS2500 - 2026-05-12 · US FDA — Medical DevicesClass II
Octopus 4 Tissue Stabilizer, Model 29400 - 2026-05-12 · US FDA — Medical DevicesClass II
Octopus Evolution Tissue Stabilizer, Model TS2000 - 2026-05-12 · US FDA — Medical DevicesClass II
Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G; - 2026-05-12 · US FDA — Medical DevicesClass II
Oncology sets with drip chambers - 2026-05-12 · US FDA — Medical DevicesClass II
Oncology sets with drip chambers - 2026-05-12 · US FDA — Medical DevicesClass II
IV Sets with drip chambers - 2026-05-12 · US FDA — Medical DevicesClass II
Plum administration sets - 2026-05-12 · US FDA — Medical DevicesClass II
IV Sets with drip chambers - 2026-05-12 · US FDA — Medical DevicesClass II
IV Non-Dedicated Gravity Administration Sets with drip chambers - 2026-05-12 · US FDA — Medical DevicesClass II
IV Sets with drip chambers - 2026-05-12 · US FDA — Medical DevicesClass II
IV Sets with drip chambers - 2026-05-11 · US FDA — Medical DevicesClass II
Power Over Fiber Base Module - 2026-05-08 · US FDA — Medical DevicesClass II
VOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001 - 2026-05-08 · US FDA — Medical DevicesClass II
GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System - 2026-05-08 · US FDA — Medical DevicesClass II
Ritmed Neurological Sponges, Description/REF: 0.5x0.5in, Non-Sterile/55992C; 0.5x1.0in, Non-Sterile/55993C; 0.5x3. - 2026-05-08 · US FDA — Medical DevicesClass II
Ritmed Neurological Sponges, 0.75x0.75in, Sterile, REF: 85995C - 2026-05-07 · US FDA — Medical DevicesClass II
Bicarby Dialysate; Model number: RFP-400-G; - 2026-05-07 · US FDA — Medical DevicesClass II
3mensio Workstation (Vascular Fenestrated) software - 2026-05-06 · US FDA — Medical DevicesClass II
Neptune Smart Docking Station (120V), Catalog Number 0770-100-000, part of the Neptune Waste Management System - 2026-05-04 · US FDA — Medical DevicesClass II
MEDLINE Medical Procedure Kits labeled as: 1) BASIC HEART PACK, Medline Kit/SKU DYNJ67331B; 2) CARDIAC SURGERY, Med - 2026-05-04 · US FDA — Medical DevicesClass II
MEDLINE Medical Procedure Kits labeled as: 1) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483A; 2) CV DRAPING/B - 2026-05-04 · US FDA — Medical DevicesClass II
MEDLINE Medical Procedure Kits labeled as CH OPEN HEART, ADULT CARDIAC KIT, AHT CVOR CABG, APH EMERGENCY OPEN HEART PACK - 2026-05-04 · US FDA — Medical DevicesClass II
MEDLINE Medical Procedure Kits labeled as: LAPAROSCOPY COMBINED - NO NDL, Medline Kit Number/SKU DYNJ37378A - 2026-05-04 · US FDA — Medical DevicesClass II
MEDLINE Medical Procedure Kits labeled as: PELVIC LAP PACK, Medline Kit Number/ SKU DYNJ53820B - 2026-05-04 · US FDA — Medical DevicesClass II
SD LTM 64 PLUS, EEG Amplifier/recorder, Model/Catalog Number: SD LTM 64 PLUS, Software Version: firmware 2021.02, 2022.0 - 2026-05-04 · US FDA — Medical DevicesClass II
MEDLINE Medical Procedure Kits labeled as: BILAT MICRO VASECTOMY REVERSAL, Medline Kit Number/SKU DYNJ68302 - 2026-05-04 · US FDA — Medical DevicesClass II
MEDLINE Medical Procedure Kits labeled as CLOVIS HYSTEROSCOPY, CSC-N PELVISCOPY, D AND C PACK, D&C HYSTER PACK, FLWR GYN - 2026-05-04 · US FDA — Medical DevicesClass II
MEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag, 16 Fr, 1000mL, Medline Product Number/SKU (RE - 2026-05-04 · US FDA — Medical DevicesClass II
MEDLINE Medical Procedure Kits labeled as: ORAL RESTORATION, Medline Kit Number/SKUDYNJ86253A - 2026-05-04 · US FDA — Medical DevicesClass II
MEDLINE Medical Procedure Kits labeled as: CATH 22F ROBINSON STRL 5'S PK, Medline Kit Number/SKU DYNJ0040839 - 2026-05-04 · US FDA — Medical DevicesClass II
MEDLINE Medical Procedure Kits labeled as: 1) CHEST EXPLORATION ECMO, Medline Kit Number/SKU DYNJ63789A; 2) CORONAR - 2026-05-04 · US FDA — Medical DevicesClass II
MEDLINE Medical Procedure Kits labeled as: NURSING KIT, Medline Kit Number/SKU EDUC1044 - 2026-05-04 · US FDA — Medical DevicesClass II
MEDLINE Medical Procedure Kits labeled as: 1) KIT UROLOGY URETHROPLASTY, Medline Kit Number/SKU DYKMBNDL117C; 2) UR - 2026-05-04 · US FDA — Medical DevicesClass II
MEDLINE Medical Procedure Kits labeled as BASIC GYN, CW LAP GYN, D&C HYSTEROSCOPY, CW LAP GYN, DEACONESS PELVIC LAP PA - 2026-05-04 · US FDA — Medical DevicesClass II
MEDLINE Medical Procedure Kits labeled as: 1) BR L&D PACK, Medline Kit Number/SKU DYNJ47625B; 2) GYN VAGINAL, Medli - 2026-05-04 · US FDA — Medical DevicesClass II
MEDLINE Medical Procedure Kits labeled as: 1) D AND C PACK, Medline Kit Number/SKU DYNJ53973C; 2) PK CUST CV A&B CA - 2026-05-04 · US FDA — Medical DevicesClass II
MEDLINE Urethral Catheter, Red Rubber Latex, Medline Product Number/SKU (REF), French sizes: 1. DYND13508 - 08 Fr; 2 - 2026-05-04 · US FDA — Medical DevicesClass II
MEDLINE Urethral Catheterization Tray and Bag, Red Rubber Latex, 15 Fr, Medline Product Number/SKU (REF) DYND18350 - 2026-05-04 · US FDA — Medical DevicesClass II
MEDLINE Urethral Catheterization Tray, Red Rubber Latex, Medline Product Number/SKU (REF), French sizes: 1. DYNC1816, - 2026-05-04 · US FDA — Medical DevicesClass II
MEDLINE Pre-connected Urethral Catheterization Tray and Bag, Red Rubber Latex, 15 Fr, Medline Product Number/SKU (REF) D - 2026-05-04 · US FDA — Medical DevicesClass II
MEDLINE Medical Procedure Kits labeled as BIOBURDEN TEST KIT, Kit Uro Robot Cystectomy, etc. (see the recall documents f - 2026-05-04 · US FDA — Medical DevicesClass II
MEDLINE Medical Procedure Kits labeled as: 1) CRANI, Medline Kit Number/SKU DYNJ908097; 2) CRANI, Medline Kit Numbe - 2026-05-04 · US FDA — Medical DevicesClass II
MEDLINE Medical Procedure Kits labeled as: 1) CAROTID NEURO PACK, Medline Kit Number/SKU DYNJ44926G; 2) VP SHUNT CD - 2026-05-04 · US FDA — Medical DevicesClass II
MEDLINE Medical Procedure Kits labeled as: DR FERNANDEZ, Medline kit number/SKU DYNJ68808 - 2026-05-04 · US FDA — Medical DevicesClass II
MEDLINE Medical Procedure Kits labeled as: TONSIL PACK CATH, Medline Kit Number/SKU DYNJ65199A - 2026-05-04 · US FDA — Medical DevicesClass II
MEDLINE Medical Procedure Kits labeled as: 1) BNT CV PACK, Medline Kit Number/SKU DYNJ912271; 2) CV PACK PART 1, Me - 2026-05-04 · US FDA — Medical DevicesClass II
MEDLINE Medical Procedure Kits labeled as: 1) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS983775I; 2) RETINA LAC/ - 2026-05-04 · US FDA — Medical DevicesClass II
MEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag, 14 Fr, 1000mL, Medline Product Number/SKU (RE - 2026-05-04 · US FDA — Medical DevicesClass II
MEDLINE Medical Procedure Kits labeled as: KIT URO ROBOT CYSTECTOMY, D AND C PACK, MAD D & C, VPH LITHOTOMY MINOR, TR - 2026-05-04 · US FDA — Medical DevicesClass II
MEDLINE Medical Procedure Kits labeled as: ADULT TRACHEOSTOMY TUBE INSERT, ASC T&A, CONWAY T&A SINUS, EAR PACK, etc. - 2026-05-01 · US FDA — Medical DevicesClass II
Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and 6600-1461-500 - 2026-05-01 · US FDA — Medical DevicesClass II
Giraffe OmniBed, a combination of an infant incubator and an infant warmer, All Models - 2026-05-01 · US FDA — Medical DevicesClass II
Giraffe OmniBed Carestations and Giraffe OmniBed Carestation CS1, a combination of an infant incubator and an infant war - 2026-04-30 · US FDA — Medical DevicesClass II
Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, 722221), Azurion 3 M15 (722064, 722222), - 2026-04-30 · US FDA — Medical DevicesClass II
Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10 OR T - 2026-04-30 · US FDA — Medical DevicesClass II
Short Monobloc Stem Broaches, Size/REF: 7/04.01.10.0970, 8/04.01.10.0971, 9/04.01.10.0972, 10/04.01.10.0973, 11/04. - 2026-04-28 · US FDA — Medical DevicesClass II
Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), Azurion 3 M15 (722064), Azurion 7 B12 ( - 2026-04-28 · US FDA — Medical DevicesClass II
Integris-Allura system; System Code Description (Model Numbers): Integris CV Cesar-Powerpack-Visub-Nicol (722030), Integ - 2026-04-28 · US FDA — Medical DevicesClass II
Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura X - 2026-04-28 · US FDA — Medical DevicesClass II
Power F2 Powered Fastening System, Power F2, Item No. 0567093 used with Power X2 Stretchers, Power X2, Item No. 0015816 - 2026-04-27 · US FDA — Medical DevicesClass II
PhaseOne Antimicrobial Solution, Model/Catalog Number: 15050 - 2026-04-24 · US FDA — Medical DevicesClass II
GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603-902, Product Code KSA; used in - 2026-04-24 · US FDA — Medical DevicesClass II
Avanta Multi-Patient Administration Tube Sets (AVA 500 MPAT (Part 2 of 2)) used with the Medrad Avanta Injection System; - 2026-04-24 · US FDA — Medical DevicesClass II
GE HealthCare ApexPro v6.0 eDelivery Software, REF #5700026, Product Code SUV; used in conjunction wtih ApexPro CARESCAP - 2026-04-24 · US FDA — Medical DevicesClass II
GE HealthCare CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603, Product Code KSA; used in conjunction - 2026-04-24 · US FDA — Medical DevicesClass II
CASE v7.0 Cardiac Testing System Model no. 3031234-001 Product Code SU3 - 2026-04-24 · US FDA — Medical DevicesClass II
GE HealthCare IOU ASSY ARK2250 CARESCAPE TELEMETRY SERVER, REF #2108729-901, Product Code SS9; ApexPro CARESCAPE Telemet - 2026-04-24 · US FDA — Medical DevicesClass II
GE HealthCare APEXPRO v5.0 - ARK2250 - Software Disaster Recovery USB Kit - Orderable by GE Service only, REF #2108523-0 - 2026-04-24 · US FDA — Medical DevicesClass II
GE HealthCare CARESCAPE TELEMETRY SERVER V5 ATO MODEL, REF #2063702-101, Product Code SS9; used in conjunction with Apex - 2026-04-23 · US FDA — Medical DevicesClass II
OneLIF Interbody Cage (REF/Description): 010-107-1007/Small 7 Degree 10mm X 7mm, 010-107-1007-2/Small 7 Degree 10mm X - 2026-04-22 · US FDA — Medical DevicesClass II
Da Vinci ASSY, PSS, SP1098, Part Number: 380601 - 2026-04-22 · US FDA — Medical DevicesClass II
Brand Name: Exacta Mix Product Name: Vented Micro-Volume Inlet Model/Catalog Number: H938175 Product Description: - 2026-04-21 · US FDA — Medical DevicesClass II
Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310 - 2026-04-20 · US FDA — Medical DevicesClass II
Allia IGS 3 Pulse angiographic X-ray system - 2026-04-20 · US FDA — Medical DevicesClass II
Allia IGS Pulse angiographic X-ray system - 2026-04-20 · US FDA — Medical DevicesClass II
Allia Moveo angiographic X-ray system - 2026-04-20 · US FDA — Medical DevicesClass II
Allia IGS 5 Pulse angiographic X-ray system - 2026-04-20 · US FDA — Medical DevicesClass II
Allia IGS 7 Pulse angiographic X-ray system - 2026-04-16 · US FDA — Medical DevicesClass II
Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: IE800.A Software Version: 1.0.20 Produ - 2026-04-15 · US FDA — Medical DevicesClass II
Fresh Roast Systems ColorTrack. Model Name: ColorTrack. Model Number: BENCH R-100 - 2026-04-14 · US FDA — Medical DevicesClass II
Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145. - 2026-04-14 · US FDA — Medical DevicesClass II
Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 782118. 2. Model Numbe - 2026-04-14 · US FDA — Medical DevicesClass II
Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. - 2026-04-14 · US FDA — Medical DevicesClass II
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Numbe - 2026-04-14 · US FDA — Medical DevicesClass II
Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782143. 2. Model Number (REF):