Browse recalls
Issuing authority: US FDA — Medical Devices
- 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 I
BD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF: 49000437; KIT ASSY ONE PIECE BEZEL 8100, - 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 - 2025-10-10 · US FDA — Medical DevicesClass I
Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; OPEN HEART SUPPLEMENT DYNJ909116D; V - 2025-10-10 · US FDA — Medical DevicesClass I
Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; Product description/Product numbers: - 2025-10-10 · US FDA — Medical DevicesClass I
DYNJ909119G ROBOTIC GASTRIC LAP SLEEVE-LF DYNJ909127F CYSTO DYNJ909129D GENERAL LAPAROSCOPY-LF - 2025-10-10 · US FDA — Medical DevicesClass I
Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; ENT DYNJ909128I; LARYNGOSCOPY - BRON - 2025-10-10 · US FDA — Medical DevicesClass I
Convenience Kit, BREAST HERNIA DYNJ909125G - 2025-10-10 · US FDA — Medical DevicesClass I
Convenience kits; DYNJ901047R ORTHO SPINE FUMICH DYNJ902308K TOTAL JOINT DYNJ909111F DR SALMA'S SPINE DYNJ909117G PA - 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 - 2025-10-02 · US FDA — Medical DevicesClass I
IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359; 23" (58 cm - 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 I
IMRIS Operating Suite, Neuro III-SV iMRI System, iMRX System, containing Siemens 3 Tesla MRI Magnet, Verio - 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 I
IMRIS Operating Suite, InVision 3T Operating Suite, containing Siemens 3 Tesla MRI Magnet, Vida - 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 - 2025-09-17 · US FDA — Medical DevicesClass I
Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) - 2025-09-12 · US FDA — Medical DevicesClass II
Elscint SPX6; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging - 2025-09-12 · US FDA — Medical DevicesClass II
Millenium MPR; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging - 2025-09-12 · US FDA — Medical DevicesClass II
Elscint Model 4XX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging - 2025-09-12 · US FDA — Medical DevicesClass II
Millenium MG/MC; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging - 2025-09-12 · US FDA — Medical DevicesClass II
Millenium Myosight; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging - 2025-09-12 · US FDA — Medical DevicesClass II
Starcam/Camstar; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging - 2025-09-12 · US FDA — Medical DevicesClass II
Elscint Helix; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging - 2025-09-12 · US FDA — Medical DevicesClass II
Sopha Medical Vision (SMV) DSXi/DST-XLi,/ DST-XL/ DSTi; dual-head nuclear medicine gamma camera designed specifically fo - 2025-09-12 · US FDA — Medical DevicesClass II
Elscint SPX4; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging - 2025-09-12 · US FDA — Medical DevicesClass II
Elscint Varicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging - 2025-09-12 · US FDA — Medical DevicesClass II
Millenium MPS; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging - 2025-09-09 · US FDA — Medical DevicesClass I
NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I - 2025-09-08 · US FDA — Medical DevicesClass II
CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU - 2025-09-05 · US FDA — Medical DevicesClass II
GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5, Part Number 5867474-03; M - 2025-09-05 · US FDA — Medical DevicesClass II
Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0893-0 - 2025-09-05 · US FDA — Medical DevicesClass II
GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5; Part Number 5867474-04; M - 2025-09-05 · US FDA — Medical DevicesClass II
Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-1 - 2025-09-04 · US FDA — Medical DevicesClass II
Medical convenience kits Item Number/Description HSAN63N ANGIO PACK IHAN02W ANGIOGRAPHY PACK MHCA98AK CORONARY AN - 2025-09-04 · US FDA — Medical DevicesClass II
Medical convenience kits Item Number/Description BFCT04X CATARACT PACK - 205986 CMEY17AI EYE PACK - 213187 CMEY17 - 2025-09-04 · US FDA — Medical DevicesClass II
Medical convenience kits Item Number/Description BUCY78E CYSTO PACK CMCP10X CYSTO PACK - 205972 IHCY10Y CYSTO PAC - 2025-09-04 · US FDA — Medical DevicesClass II
Medical convenience kits Item number/ Product description AHLD15X LABOR DELIVERY PACK - 213387 AKDV96B VAGINAL DEL - 2025-09-04 · US FDA — Medical DevicesClass II
Medical convenience kits IHDC30R D AND C PACK - 2025-09-04 · US FDA — Medical DevicesClass II
Basic Biopsy Tray, Item Number NMBP44L - 2025-09-04 · US FDA — Medical DevicesClass II
Medical convenience kits Item Number/Description ANSH14AF SHOULDER PACK - 205962 EVAH76H ANTERIOR HIP PACK FDSA15 - 2025-09-04 · US FDA — Medical DevicesClass II
Basic Biopsy Tray; Item Number/Description: AKRB26D ROBOTIC, AMGL09AA GENERAL LAPAROSCOPY, ANLC35AD LAP CHOLE PAC - 2025-09-03 · US FDA — Medical DevicesClass II
Allura Xper FD20 Biplane Product Codes: (1)722013, (2) 722008; Associated 510(k) numbers: K102005, K130842, K130638, K13 - 2025-09-03 · US FDA — Medical DevicesClass II
Allura Xper FD20/15; Product Code: 722058; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K1615 - 2025-09-03 · US FDA — Medical DevicesClass II
Allura Xper FD10/10 Product Codes: (1)722011, (2) 722027, (3) 722005; Associated 510(k) numbers: K102005, K130842, K1306 - 2025-09-03 · US FDA — Medical DevicesClass II
Allura Xper FD20/15 OR Table; Product Code: 722059; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K1419 - 2025-09-03 · US FDA — Medical DevicesClass II
Allura Xper FD10 OR Table Product Codes: (1)722022, (2) 722033; Associated 510(k) numbers: K102005, K130842, K130638, K1 - 2025-09-03 · US FDA — Medical DevicesClass II
Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K1 - 2025-09-03 · US FDA — Medical DevicesClass II
Allura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, - 2025-09-03 · US FDA — Medical DevicesClass II
Allura Xper FD20/10; Model Numbers: 722029; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, - 2025-09-03 · US FDA — Medical DevicesClass II
Allura Xper FD20/20 OR Table; Model Numbers: 722039; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, - 2025-09-03 · US FDA — Medical DevicesClass II
Allura Xper FD10 OR Table; Model Numbers: 722033; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K16 - 2025-09-03 · US FDA — Medical DevicesClass II
Allura CV20; Product Code: 722031; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162 - 2025-09-03 · US FDA — Medical DevicesClass II
Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K16 - 2025-09-03 · US FDA — Medical DevicesClass II
Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638, - 2025-09-03 · US FDA — Medical DevicesClass II
Allura Xper FD20 Biplane OR Table; Model Numbers: (1) 722020, (2) 722025; Associated 510(k)s: K102005, K130638, K13084 - 2025-09-03 · US FDA — Medical DevicesClass II
Allura Xper CV20; Model Numbers: 722031; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K16 - 2025-09-03 · US FDA — Medical DevicesClass II
Allura Xper FD20 OR Table Product Codes: (1)722023, (2) 722035, (3) 722015; Associated 510(k) numbers: K102005, K130842, - 2025-09-03 · US FDA — Medical DevicesClass II
Allura Xper FD20 Biplane; Model Numbers: (1) 722008, (2) 722013; Associated 510(k)s: K102005, K130638, K130842, K13329