Category
Medical Devices Recalls
15,654 medical devices recalls on record from CPSC, FDA, and USDA.
15,654 recalls
High RiskFDA
Canon Medical System, Usa, Inc.
VANTAGE GALAN 3T Model MRT-3020/MEXL-3020
Medical Devices34 affectedDec 19, 2025
High RiskFDA
Icu Medical, Inc.
Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000
Medical Devices14,684,607 affectedDec 19, 2025
High RiskFDA
Tyber Medical
Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/14Shaft/Left/Std/186mm Model/Catalog Numbe...
Medical Devices64 affectedDec 19, 2025
High RiskFDA
Canon Medical System, Usa, Inc.
Alphenix INFX-8000F, interventional fluoroscopic x-ray system
Medical Devices98 affectedDec 19, 2025
High RiskFDA
Siemens Medical Solutions Usa, Inc
NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
Medical Devices2 affectedDec 19, 2025
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
Medical Devices2 affectedDec 19, 2025
High RiskFDA
Icu Medical Inc.
Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG
Medical Devices64,290 affectedDec 19, 2025
High RiskFDA
Canon Medical System, Usa, Inc.
VANTAGE TITAN 3T Model MRT-3010/MEXL-3010
Medical Devices22 affectedDec 19, 2025
High RiskFDA
Altruan Gmbh
Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci (Strep A) in throat swab samples.
Medical Devices188 affectedDec 19, 2025
High RiskFDA
Wilson-cook Medical Inc.
Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784 UDI-DI code: 00827002607842 REF: TESLA-B2535-450 Model...
Medical Devices153 affectedDec 18, 2025
High RiskFDA
Community Products, Llc
Rifton Equipment, TRAM. Model/Catalog Number: K310. The TRAM is a powered lift device for transferring clients in a seated position or...
Medical Devices3,238 affectedDec 18, 2025
High RiskFDA
Community Products, Llc
Rifton Equipment, E-Pacer. Model/Catalog Number: K660. The E-Pacer is a gait training device with power height adjustment that facili...
Medical Devices470 affectedDec 18, 2025
High RiskFDA
Aju Pharm Co., Ltd.
AlternatiV+ Screw-In Anchor
Medical Devices416 affectedDec 17, 2025
High RiskFDA
Aju Pharm Co., Ltd.
Genesis Push-In Suture Anchor
Medical Devices200 affectedDec 17, 2025
High RiskFDA
Aju Pharm Co., Ltd.
Fixone Biocomposite Anchor
Medical Devices1,088 affectedDec 17, 2025
High RiskFDA
Aju Pharm Co., Ltd.
Fixone Hybrid Anchor
Medical Devices233 affectedDec 17, 2025
High RiskFDA
Aju Pharm Co., Ltd.
Genesis Knotless Anchor
Medical Devices1,163 affectedDec 17, 2025
High RiskFDA
Aju Pharm Co., Ltd.
AlternatiV+ Max Knotless Anchor
Medical Devices2,569 affectedDec 17, 2025
High RiskFDA
Vortex Surgical Inc.
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.25GA Convenience Ki...
Medical Devices14,789 affectedDec 16, 2025
High RiskFDA
Medline Industries, Lp
Medline medical procedure convenience kits labeled as: KIT ROBOTICS UROLOGY PROSTATE, REF DYKMBNDL116G
Medical Devices12 affectedDec 16, 2025
High RiskFDA
Medline Industries, Lp
Medline medical procedure convenience kits labeled as: 1) LAVH PROCEDURE, REF CDS980754T; 2) GYN LAP HYSTERECTOMY CDS, REF CDS982662...
Medical Devices1,457 affectedDec 16, 2025
High RiskFDA
Medline Industries, Lp
Medline medical procedure convenience kits labeled as: 1) LAPAROSCOPY CDS-LF, REF CDS860235L; 2) GENERAL LAPAROSCOPIC, REF CDS930223...
Medical Devices41,432 affectedDec 16, 2025
High RiskFDA
Vortex Surgical Inc.
Oertli 1. 23G Laser Probe OS4 Flex-Tip VK401113 2. 23G Laser Probe OS4 Illuminated Flex-Tip VK401213 3. 23G Laser Probe OS4 Intu...
Medical Devices14,789 affectedDec 16, 2025
High RiskFDA
Immunotech A.s.
Estrone RIA, REF: DSL8700
Medical Devices160 affectedDec 15, 2025
High RiskFDA
Intuitive Surgical, Inc.
da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1098,Box)
Medical Devices41,526 affectedDec 15, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD10F; Model Number: 722002;
Medical Devices12 affectedDec 15, 2025
CriticalFDA
Sunmed Holdings, Llc
Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700RE Software Version: Not Applic...
Medical Devices20,583 affectedDec 15, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD10/10; Model Number: 722027;
Medical Devices22 affectedDec 15, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD20; Model Number: 722028;
Medical Devices2 affectedDec 15, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Product Name: Allura Xper FD10C; Model number: 722001;
Medical Devices38 affectedDec 15, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD10; Model Number: 722003;
Medical Devices93 affectedDec 15, 2025
High RiskFDA
Icu Medical, Inc.
ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)
Medical Devices0 affectedDec 15, 2025
High RiskFDA
Icu Medical, Inc.
ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines)
Medical Devices0 affectedDec 15, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD10/10; Model Number: 722011;
Medical Devices21 affectedDec 15, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD20/20; Model Number: 722038;
Medical Devices8 affectedDec 15, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD10/10; Model Number: 722005;
Medical Devices14 affectedDec 15, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD20; Model Number: 722012;
Medical Devices79 affectedDec 15, 2025
High RiskFDA
Diagnostica Stago, Inc.
Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is intended for the qualitative detection in plasma or serum...
Medical Devices438 affectedDec 15, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD20/10; Model Number: 722029;
Medical Devices4 affectedDec 15, 2025
High RiskFDA
Icu Medical, Inc.
ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines)
Medical Devices0 affectedDec 15, 2025
High RiskFDA
Integra Lifesciences Corp. (neurosciences)
Codman Microsensor Basic Kit. Catalog Number: 626631US. Use of the CODMAN MICROSENSOR Basic Kit is indicated when direct ICP monitori...
Medical Devices1,301 affectedDec 12, 2025
High RiskFDA
Medline Industries, Lp
Medline medical procedure convenience kits labeled as: 1) WATKINS SPINE PACK-LF, Kit SKU DYNJ0275635M; 2) SM-SPINE PACK-LF, Kit SKU ...
Medical Devices117 affectedDec 12, 2025
High RiskFDA
Elekta, Inc.
Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11,3, 11.4 Product Description...
Medical Devices0 affectedDec 12, 2025
High RiskFDA
Medline Industries, Lp
Medline medical procedure convenience kits labeled as: NERVE BLOCK TRAY 2, Kit SKU DYNJRA2713
Medical Devices0 affectedDec 12, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Philips Azurion system; Software Version Number: R3.1;
Medical Devices228 affectedDec 12, 2025
High RiskFDA
Medline Industries, Lp
Medline medical procedure convenience kits labeled as: 1) BREAST-HERNIA-PORT CDS-LF, Kit SKU CDS984853L; 2) BREAST BIOPSY PACK, Kit ...
Medical Devices1,928 affectedDec 12, 2025
High RiskFDA
Medline Industries, Lp
Medline medical procedure convenience kits labeled as: 1) SMJ LAP CHOLE PACK-LF, Kit SKU DYNJ19974P; 2) DEPAUL ABDOMINAL ENDOSCOPY-L...
Medical Devices456 affectedDec 12, 2025
High RiskFDA
Medline Industries, Lp
Medline medical procedure convenience kits labeled as: 1) INPATIENT CTRL LN DRG CHG, Kit SKU DT22880; 2) ADULT CVC DRSG CHG W/ADHESI...
Medical Devices1,928 affectedDec 12, 2025