Browse recalls
Issuing authority: US FDA — Medical Devices
- 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 I
MEDLINE ANTERIOR HIP, Medline Kit SKU DYNJ909640G - 2026-06-05 · US FDA — Medical DevicesClass I
MEDLINE convenience kits labeled as: 1) C-SECTION, Medline SKU DYNJ910835; 2) C-SECTION, Medline SKU DYNJ910835A; m - 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. - 2026-06-05 · US FDA — Medical DevicesClass I
MEDLINE convenience kits labeled as: 1) TOTAL JOINT KIT, Medline Kit SKU DYKS1574A; 2) TOTAL KNEE BASIC, Medline Ki - 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 I
Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 - 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 I
Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Catalog Number REF M08473; Oscillation Lung E - 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 - 2026-05-21 · US FDA — Medical DevicesClass I
Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/Catalog Number REF M08474; Oscillation Lung - 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 I
Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF M08085; Oscillation Lung Expa - 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 - 2026-05-21 · US FDA — Medical DevicesClass I
Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog Number REF M08270; Oscillation Lung Exp - 2026-05-20 · US FDA — Medical DevicesClass I
Omnipod 5 Pods. Includes the below Model/REF Numbers: 1. POD-OMNI-I1-6720. 2. POD-OMNI-I1-6220. 3. OMNI-I1-67 - 2026-05-20 · US FDA — Medical DevicesClass I
Omnipod DASH Pod. Includes the below Model/REF Numbers: 1. POD-BLE-I1-525 (5-Pack), POD-BLE-I1-520 (Single Pod). - 2026-05-20 · US FDA — Medical DevicesClass I
Omnipod (Eros) Pod. Includes the below Model/REF Numbers: 1. POD-ZXP425 (10 Pack), POD- ZXP420 (Single Pod). 2. - 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 - 2026-05-15 · US FDA — Medical DevicesClass I
Reprocessed Electrophysiology Catheters and Ultrasound Catheters Item no. 401206RH, St. Jude Medical Response" Diagno - 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 I
Giraffe Stand-alone Infant Resuscitation System; Powered emergency ventilator (resuscitator) Product identifiers: 20826 - 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 I
Giraffe Warmer with Integrated Resuscitation System (iRes), Panda Warmer with Integrated Resuscitation System (iRes) Pro - 2026-05-08 · US FDA — Medical DevicesClass I
Panda Freestanding Warmer, Infant Radiant Warmer Product Identifiers: 2063568-001 Impacted only if service blender M109 - 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 I
Spinocan Spinal Needle procedure kits: Material Description (Material Number): Spinocan 26 Ga. x 3-1/2 in. (90 mm), B - 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 - 2026-05-06 · US FDA — Medical DevicesClass I
Medline Convenience Kits: 1) DYNJ905503F, Model Number: CV ANESTHESIA - ROOM SET UP; 2) DYNJ905503G, Model Number: C - 2026-05-06 · US FDA — Medical DevicesClass I
Medline Convenience Kits: 1) DRAWER 6A ADULT CENTRAL LINE, Model Number: ACC010890; 2) OPEN HEART A OVERHEAD, Model - 2026-05-06 · US FDA — Medical DevicesClass I
Spinal Needle procedure kits: Material Description (Material Number) 24GA. PENCAN SPINAL BUP. TRAY W/DURAPREP (333867 - 2026-05-06 · US FDA — Medical DevicesClass I
Medline Convenience Kits: 1) DRAWER 6 CENTRAL LINE INSERTIO, Model Number: ACC011142; 2) CENTRAL AND ARTERIAL LINE T - 2026-05-06 · US FDA — Medical DevicesClass I
Medline Convenience Kits: 1) OPEN HEART CDS, Model Number: CDS840144Q; 2) OPEN HEART, Model Number: CDS840150W; 3) - 2026-05-06 · US FDA — Medical DevicesClass I
Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004 - 2026-05-06 · US FDA — Medical DevicesClass I
Design Options Spinal Tray Spinal Needle Anesthesia procedure kits: Material Description (Material Number): SSK H M C - 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