Browse recalls
Alert level: Class II
- 2025-12-15 · US FDA — Medical DevicesClass II
Allura Xper FD20/20; Model Number: 722038; - 2025-12-15 · US FDA — Medical DevicesClass II
Allura Xper FD10/10; Model Number: 722005; - 2025-12-15 · US FDA — Medical DevicesClass II
Allura Xper FD20; Model Number: 722012; - 2025-12-15 · US FDA — Medical DevicesClass II
Allura Xper FD20/10; Model Number: 722029; - 2025-12-15 · US FDA — Medical DevicesClass II
ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines) - 2025-12-12 · US FDA — Medical DevicesClass II
Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11,3, 11.4 Pr - 2025-12-12 · US FDA — Medical DevicesClass II
Philips Azurion system; Software Version Number: R3.1; - 2025-12-12 · US FDA — Medical DevicesClass II
Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the following label descriptions and corres - 2025-12-11 · US FDA — Medical DevicesClass II
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Product - 2025-12-11 · US FDA — Medical DevicesClass II
Product Name: Lumipulse G pTau 217 Plasma Calibrators Model/Catalog Number: 81557 Software Version: Not Applicable Pr - 2025-12-11 · US FDA — Medical DevicesClass II
Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Model/Catalog Number: CL0073 Software Version: Not Appli - 2025-12-11 · US FDA — Medical DevicesClass II
Product Name: Lumipulse ¿-Amyloid Plasma Controls Model/Catalog Number: 81559 Software Version: Not Applicable Produc - 2025-12-10 · US FDA — Medical DevicesClass II
MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO) - 2025-12-10 · US FDA — Medical DevicesClass II
MAVERICK Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-0149 - 2025-12-10 · US FDA — Medical DevicesClass II
SMV DSI, System, Tomography, Computed, Emission - 2025-12-09 · US FDA — Medical DevicesClass II
Brand Name: PALACOS Product Name: PALACOS R+G pro 40; PALACOS R+G pro 80 Model/Catalog Number: 5081288; 5081289 Softw - 2025-12-08 · US FDA — Medical DevicesClass II
Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. M - 2025-12-05 · US FDA — Medical DevicesClass II
BVI Leos Laser and Endoscopy System. Model Number: OME6000U. - 2025-12-05 · US FDA — Medical DevicesClass II
LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471 - 2025-12-02 · US FDA — Medical DevicesClass II
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: - 2025-12-02 · US FDA — Medical DevicesClass II
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: - 2025-12-02 · US FDA — Medical DevicesClass II
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: - 2025-12-02 · US FDA — Medical DevicesClass II
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: - 2025-12-02 · US FDA — Medical DevicesClass II
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: - 2025-12-02 · US FDA — Medical DevicesClass II
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: - 2025-12-02 · US FDA — Medical DevicesClass II
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: - 2025-12-02 · US FDA — Medical DevicesClass II
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: - 2025-12-02 · US FDA — Medical DevicesClass II
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: - 2025-11-28 · US FDA — Medical DevicesClass II
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 17.0.0, 17.0.1 Software Version: RaySta - 2025-11-28 · US FDA — Medical DevicesClass II
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 14.0.0, 15.0.0, 15.1.3 Software Version - 2025-11-28 · US FDA — Medical DevicesClass II
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 15.2.0, 15.1.3 Software Version: RaySta - 2025-11-28 · US FDA — Medical DevicesClass II
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 16.0.0 Software Version: RayStation 202 - 2025-11-28 · US FDA — Medical DevicesClass II
RayStation/RayPlan. Model/Catalog Numbers: 12.0.0, 12.1.0, 12.0.3, 12.0.4, 12.3.0. Software Version: RayStation 11B, R - 2025-11-28 · US FDA — Medical DevicesClass II
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 13.0.0.1547, 13.1.0.144, 13.1.1.89 Soft - 2025-11-28 · US FDA — Medical DevicesClass II
RayStation/RayPlan. Model/Catalog Numbers: 11.0.0, 11.0.1, 11.0.3, 11.0.4. Software Version: RayStation 11A, RayStation - 2025-11-28 · US FDA — Medical DevicesClass II
SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2 - 2025-11-26 · US FDA — Medical DevicesClass II
Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit - 2025-11-26 · US FDA — Medical DevicesClass II
Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; Immunoassay Method, Troponin Subunit - 2025-11-26 · US FDA — Medical DevicesClass II
Philips Tempus Pro Patient Monitor, REF: 00-1004, 00-1007, 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. USB 2-Channel - 2025-11-24 · US FDA — Medical DevicesClass II
LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02 - 2025-11-24 · US FDA — Medical DevicesClass II
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02 - 2025-11-22 · US FDA — Medical DevicesClass II
Male Fertility Sperm Test for Home Use (Cassette) - 2025-11-22 · US FDA — Medical DevicesClass II
Exploro Highly Sensitive Male Fertility / Sperm Concentration Test - 2025-11-22 · US FDA — Medical DevicesClass II
Vivoo Protein Test - 2025-11-22 · US FDA — Medical DevicesClass II
LotFancy Urinary Tract Infection Urine (UTI) Test Strips; PALINOIA UTI-10 PARAMETER REAGENT STRIPS; Vaunn Medical 8-in - 2025-11-22 · US FDA — Medical DevicesClass II
S. Typhi/Para Typhi A Antigen - 2025-11-21 · US FDA — Medical DevicesClass II
Medline Hudson RCI Medium Concentration Oxygen Masks: 1041CE MASK,OXYGEN,UND CHIN,MED CO OUS ONLY; HUD1035 O2 MASK - 2025-11-20 · US FDA — Medical DevicesClass II
BD Pyxis MedStation ES, REF: 323, BD Pyxis MedStation ES 7 Drawer Auxiliary, REF: 324, BD Pyxis MedStation ES Tower - 2025-11-20 · US FDA — Medical DevicesClass II
Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers: CT900A PROG CT90 - 2025-11-17 · US FDA — Medical DevicesClass II
Brand Name: Molift Product Name: Molift 4-point sling bars (Accessory to mobile hoists) Model/Catalog Number: 1430116, - 2025-11-17 · US FDA — Medical DevicesClass II
Brand Name: Molift Product Name: Molift Mover 205 Model/Catalog Number: (1) M14000, (2) M1401, (3) M1402, (4) M14050, - 2025-11-13 · US FDA — Medical DevicesClass II
Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20 - 2025-11-07 · US FDA — Medical DevicesClass II
Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibratio - 2025-11-06 · US FDA — Medical DevicesClass II
MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100) - 2025-10-29 · US FDA — Medical DevicesClass II
CT 5300; Software Version Number: 4.5, 5.0, 5.1; - 2025-10-29 · US FDA — Medical DevicesClass II
Incisive CT; Software Version Number: 4.5, 5.0, 5.1; - 2025-10-27 · US FDA — Medical DevicesClass II
Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM - 2025-10-21 · US FDA — Medical DevicesClass II
CareLink Clinic, REF: MMT-7350 - 2025-10-17 · US FDA — Medical DevicesClass II
Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus Nephro-EZDilate Nephro - 2025-10-13 · US FDA — Medical DevicesClass II
Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S - 2025-10-07 · US FDA — Medical DevicesClass II
SimplyGo Mini, Standard Battery Kit; Product code: 1116816; The affected battery kits are sold as accessories for th - 2025-10-06 · US FDA — Medical DevicesClass II
Food Panel 3 Specific Allergen; Siemens Material Number (SMN): 10385891; Catalog Number: FP3L4; - 2025-10-06 · US FDA — Medical DevicesClass II
Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400 - 2025-10-06 · US FDA — Medical DevicesClass II
Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400 - 2025-10-06 · US FDA — Medical DevicesClass II
3gAllergy Specific IgE Universal Kit; Kit Component: 3gAllergy Specific IgE Adjustor Antibody (L2UNS1), 3gAllergy Speci - 2025-10-06 · US FDA — Medical DevicesClass II
IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 10386105; Catalog Number: L2KUN6; - 2025-10-03 · US FDA — Medical DevicesClass II
MC3 VitalFlow Console, REF 58100; Blood pump of ecmo - 2025-10-01 · US FDA — Medical DevicesClass II
Radiography 7300 C; Model Number: 712037; - 2025-10-01 · US FDA — Medical DevicesClass II
DigitalDiagnost C90 (1) High Performance, (2) Flex/Value/Chest/ER; Model Number: (1) 712034, (2) 712035; - 2025-10-01 · US FDA — Medical DevicesClass II
Precision CRF; Model Number: 706400; - 2025-10-01 · US FDA — Medical DevicesClass II
Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer - 2025-10-01 · US FDA — Medical DevicesClass II
ProxiDiagnost N90; Model Number: 706110; - 2025-09-30 · US FDA — Medical DevicesClass II
MEDLINE convenience kits labeled as: 1) ACH PLASTICS BREAST-LF, REF CDS983639K; 2) BREAST ABD, REF CDS984267J; 3) - 2025-09-30 · US FDA — Medical DevicesClass II
MEDLINE convenience kits labeled as: CIRCUMCISION PACK, REF DYNJ16826O - 2025-09-30 · US FDA — Medical DevicesClass II
MEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81, REF DYNJ27466S; 2) MINOR EYE TRAY #81, REF DYNJ27466T. - 2025-09-30 · US FDA — Medical DevicesClass II
MEDLINE convenience kits labeled as: 1) CENTRAL LINE PACK, REF DYNJ00281P; 2) FREE FLAP PACK, REF DYNJ68213C. - 2025-09-30 · US FDA — Medical DevicesClass II
MEDLINE convenience kits labeled as: GP-LEEP PACK-LF, REF PHS396969004F - 2025-09-30 · US FDA — Medical DevicesClass II
MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY CDS #34-RF, REF CDS920099S; 2) GYN LAPAROSCOPY CDS-LF, REF - 2025-09-30 · US FDA — Medical DevicesClass II
MEDLINE convenience kits labeled as: 1) MAJOR VAGINAL HARPER PACK-LF, REF DYNJ0161768G; 2) ACH MAJOR VAGINAL PACK, - 2025-09-30 · US FDA — Medical DevicesClass II
MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075W; 2) C-SECTION, REF CDS984261J; 3) C-S - 2025-09-30 · US FDA — Medical DevicesClass II
MEDLINE convenience kits labeled as: CATH LAB PACEMAKER PACK, REF DYNJ59818A - 2025-09-30 · US FDA — Medical DevicesClass II
MEDLINE convenience kits labeled as LOCAL BASIC, REF DYNJ34418M - 2025-09-30 · US FDA — Medical DevicesClass II
MEDLINE convenience kits labeled as: 1) MAJOR LAPAROTOMY CDS, REF CDS860015W; 2) MAJOR LAPAROTOMY CDS, REF CDS86001 - 2025-09-26 · US FDA — Medical DevicesClass II
B105P, B125P, B105M, B125M, B155M Patient Monitors; Model nos. 6160000-002 6160000-003 6160000-004 6160000-005 6160000-1 - 2025-09-26 · US FDA — Medical DevicesClass II
CARESCAPE ONE, Model no. 2087075-300 - shipped with potentially affected batteries or affected batteries installed as a - 2025-09-26 · US FDA — Medical DevicesClass II
Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 44 mm O.D., Size F, Bearing, Model/Ca - 2025-09-26 · US FDA — Medical DevicesClass II
Portrait VSM Model nos. 6660000-666 Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms - 2025-09-26 · US FDA — Medical DevicesClass II
Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 46 mm O.D., Size G, Bearing, Model/Ca - 2025-09-26 · US FDA — Medical DevicesClass II
BATTERY FLEX-3S2P 10.8V 18650 LI-ION SMBUS used with affected patient monitors Model No 2062895-001 Manufacturer Pa - 2025-09-25 · US FDA — Medical DevicesClass II
Model: Incisive CT for Brazil SKD; Product Code (REF): 728146; Software Versions: 5.1.0.X & 5.1.1.X; - 2025-09-25 · US FDA — Medical DevicesClass II
Model: CT 5300; Product Code (REF): 728285; Software Versions: 5.1.0.X & 5.1.1.X; - 2025-09-25 · US FDA — Medical DevicesClass II
Model: Incisive CT; Product Code (REF): (1) 728143, (2) 728144; Software Versions: 5.1.0.X & 5.1.1.X; - 2025-09-25 · US FDA — Medical DevicesClass II
Cold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02 - 2025-09-23 · US FDA — Medical DevicesClass II
BD EpiCenter Microbiology Data Management System, labeled as the following: 1. Computer System Epicenter F/G, Catalog - 2025-09-23 · US FDA — Medical DevicesClass II
BD BACTEC Blood Culture System, labeled as the following: 1. BACTEC 9120 System, Catalog Numbers: 445570, 445702. - 2025-09-23 · US FDA — Medical DevicesClass II
iLet Bionic Pancreas, REF: BB1001 - 2025-09-19 · US FDA — Medical DevicesClass II
DxI 9000 Access Immunoassay Analyzer, Part Number C11137 - 2025-09-18 · US FDA — Medical DevicesClass II
Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723 - 2025-09-17 · US FDA — Medical DevicesClass II
Oral Probe (Product code 02893-000), accessory used with Welch Allyn SureTemp Plus 690 (Product codes 01690-200 and 0169 - 2025-09-17 · US FDA — Medical DevicesClass II
Fuse ULTRA Foot Plating System Instructions for Use. Models: OS200400, OS200401, OS328017, OS200020L, OS200025L, OS20