Browse recalls
Issuing authority: US FDA — Medical Devices
- 2026-10-06 · US FDA — Medical DevicesClass II
Philips Azurion 5 M12. Model Number: 722227. - 2026-10-06 · US FDA — Medical DevicesClass II
Philips Azurion 5 M20. Model Numbers: 722228, 722281. - 2026-10-06 · US FDA — Medical DevicesClass II
Philips Azurion S. Model Number: 722285. - 2026-10-06 · US FDA — Medical DevicesClass II
Philips Azurion 7 B20. Model Numbers: 722068, 722226. - 2026-10-06 · US FDA — Medical DevicesClass II
Philips Azurion 7 M12. Model Numbers: 722078, 722223. - 2026-10-06 · US FDA — Medical DevicesClass II
Philips Azurion 3 M12. Model Numbers: 722063, 722221. - 2026-10-06 · US FDA — Medical DevicesClass II
Philips Azurion 7 M20. Model Numbers: 722079, 722224, 722282. - 2026-10-06 · US FDA — Medical DevicesClass II
Philips Azurion 7 B12. Model Numbers: 722067, 722225. - 2026-10-06 · US FDA — Medical DevicesClass II
Philips Azurion 3 M15. Model Number: 722064, 722222, 722280. - 2026-09-30 · US FDA — Medical DevicesClass II
Nalu TD2 Therapy Disc with firmware, REF: 34014-001, and TD2 Patient Kit, REF: 74011, part of the Nalu Neurostimulation - 2026-09-25 · US FDA — Medical DevicesClass II
FORWARD Gunshot Wound Kit; Model: AFT-GSW; - 2026-09-25 · US FDA — Medical DevicesClass II
Carevo, Height-adjustable shower trolley, Model Number BAC1111-01 - 2026-09-24 · US FDA — Medical DevicesClass I
Philips Lumify Diagnostic Ultrasound System - 2026-09-23 · US FDA — Medical DevicesClass II
HexaVue Focus Integration System, a single, all-in-one system that handles operating room video routing, surgical video - 2026-09-23 · US FDA — Medical DevicesClass II
ETHILON Nylon Suture, Product Code 697G - 2026-09-22 · US FDA — Medical DevicesClass II
Generic Name: Softmed Breathables Advanced Toric (fanfilcon A) Soft (Hydrophilic) Contact Lens; Model/Catalog Number: S - 2026-09-21 · US FDA — Medical DevicesClass II
RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020115 - 2026-09-21 · US FDA — Medical DevicesClass II
RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020117 - 2026-09-21 · US FDA — Medical DevicesClass II
RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020116 - 2026-09-21 · US FDA — Medical DevicesClass II
ROTOR ASSY-SW40, Reference Number 331302, when the rotors are installed in the following centrifuges: Optima XPN-100 (Mo - 2026-09-21 · US FDA — Medical DevicesClass II
ROTOR ASSY-SW41, Reference Number 331362, when the rotors are installed in the following centrifuges: Optima XPN-100 (Mo - 2026-09-18 · US FDA — Medical DevicesClass I
Automated Impella Controller, Packaged. Primary user control interface for the Impella Catheter, catheter-based heart pu - 2026-09-18 · US FDA — Medical DevicesClass I
Impella Optical Controller, Packaged. Primary user control interface for the Impella Catheter, a catheter-based heart pu - 2026-09-18 · US FDA — Medical DevicesClass I
Impella Connect Optical AIC, Packaged. Primary user control interface for the Impella Catheter, a catheter-based heart p - 2026-09-16 · US FDA — Medical DevicesClass II
TS Universal Baseplate Finishing Tray, Triathlon. Catalog Number: 6543-6-506. - 2026-09-16 · US FDA — Medical DevicesClass II
Triathlon Hinge Femoral Prep Tray. Catalog Number: 6543-6-514. - 2026-09-16 · US FDA — Medical DevicesClass II
Williams Cystoscopic Injection Needles, used for cystoscopic injection into the urethra, bladder neck, and bladder wall, - 2026-09-16 · US FDA — Medical DevicesClass II
TS Femoral Prep Tray, Triathlon. Catalog Number: 6543-6-507. - 2026-09-16 · US FDA — Medical DevicesClass II
TS Misc. Instruments Tray, Triathlon. Catalog Number: 6543-6-519. - 2026-09-14 · US FDA — Medical DevicesClass II
Likorall Overhead Lifts Product Code: 3121001 Product Description: LIKORALL 200 Product Code: 3122005 Product De - 2026-09-11 · US FDA — Medical DevicesClass II
CareLink Clinic, REF: MMT-7350 - 2026-09-08 · US FDA — Medical DevicesClass II
PERMA-HAND Silk Black Braided Sterile Nonabsorbable Surgical Suture, 1X18" TF-5, Product Code: N271H - 2026-09-04 · US FDA — Medical DevicesClass III
LeadCare II Blood Lead Test Kit. Model/Catalog Number: 70-6762. - 2026-09-02 · US FDA — Medical DevicesClass II
DxC 500i Clinical Analyzer Modules: 1. DxC 500 AU Module w/ISE, DxC 500i, Part No. C63522 2. DxC 500 AU Module, Dx - 2026-09-02 · US FDA — Medical DevicesClass II
DxC 500 AU Clinical Chemistry Analyzers: 1. AU w/out ISE, Part No. C63519 2. AU w/ISE, Part No. C63520 - 2026-09-02 · US FDA — Medical DevicesClass II
Generic Name: MiniMed Go App Generic Name: MiniMed Go App Model/Catalog Number: MMT-8600 (iOS), MMT-8601 (Android) So - 2026-08-31 · US FDA — Medical DevicesClass II
VERIFY Biological Steam Test Pack Model/Catalog Number: S3065 - 2026-08-31 · US FDA — Medical DevicesClass II
VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB006 - 2026-08-31 · US FDA — Medical DevicesClass II
VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number: S3061 - 2026-08-31 · US FDA — Medical DevicesClass II
VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number: S3060 - 2026-08-31 · US FDA — Medical DevicesClass II
VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB007 - 2026-08-31 · US FDA — Medical DevicesClass II
VERIFY Biological Steam Test Pack Model/Catalog Number: S3069 - 2026-08-28 · US FDA — Medical DevicesClass II
Ingenia 3.0T and 3.0T CX; Model number (REF): 1. 781342 (3.0T), 2. 781377 (3.0T), 3. 782103 (3.0T), 4. 781271 (3.0T CX) - 2026-08-28 · US FDA — Medical DevicesClass II
MR 7700; Model number (REF): 1. 782120, 2. 782153, 3. 782155, 4. 782199; Software Versions: R11, R12 and R13; - 2026-08-28 · US FDA — Medical DevicesClass II
Ingenia 1.5T, 1.5T CX, and 1.5T S; Model number (REF): 1. 781315 (1.5T), 2. 781341 (1.5T), 3. 781396 (1.5T), 4. 782115 - 2026-08-28 · US FDA — Medical DevicesClass II
Evolution upgrade 1.5T amd Evolution upgrade 3.0T; Model number (REF): 1. 782116 (1.5T), 2. 782148 (1.5T), 3. 782166 (1 - 2026-08-28 · US FDA — Medical DevicesClass II
Upgrade dStream; Model number (REF): 782127; Software Versions: R11, R12 and R13; - 2026-08-28 · US FDA — Medical DevicesClass II
MR 5300; Model number (REF): 1. 782110, 2. 782152, 3. 782156, 4. 782196; Software Versions: R11, R12 and R13; - 2026-08-28 · US FDA — Medical DevicesClass II
SmartPath to MR 7700; Model number (REF): 1. 782178, 2. 782207; Software Versions: R11, R12 and R13; - 2026-08-28 · US FDA — Medical DevicesClass II
Ingenia Blue Seal SE and Blue Seal XE; Model number (REF): 1. 782185 (SE), 2. 782192 (XE); Software Versions: R11, R12 - 2026-08-28 · US FDA — Medical DevicesClass II
Ingenia Ambition S and Ingenia Ambition X.; Model number (REF): 1. 781359 (S), 2. 782108 (S), 3. 782139 (S), 4. 782159 - 2026-08-28 · US FDA — Medical DevicesClass II
Ingenia Elition S and Ingenia Elition X.; Model number (REF): 1. 781357 (S), 2. 782106 (S), 3. 782137 (S), 4. 782157 (S - 2026-08-28 · US FDA — Medical DevicesClass II
Upgrade to MR 7700; Model number (REF): 782130; Software Versions: R11, R12 and R13; - 2026-08-28 · US FDA — Medical DevicesClass II
SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for XR and 3.0T, and SmartPath to In - 2026-08-25 · US FDA — Medical DevicesClass II
SEDIPLAST; Model/Catalog Numbers: S-100 and S-1000; - 2026-08-20 · US FDA — Medical DevicesClass II
EnCor EnCompass Breast Biopsy and Tissue Removal System Console (model number: ENCPCONSOLE) and Driver (model number: EN - 2026-08-20 · US FDA — Medical DevicesClass II
Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin Pump Model/Catalog Numbers: MMT-8062; MMT-8072 Product Descr - 2026-08-19 · US FDA — Medical DevicesClass II
Presource Packs containing Medtronic Microstream Components: Intubation Kit Catalog Numbers AN23366084 AN23366085 - 2026-08-18 · US FDA — Medical DevicesClass II
PRO+ 40" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and outpu - 2026-08-18 · US FDA — Medical DevicesClass II
PRO+ MRS SURFACE FOR VERSACARE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake - 2026-08-18 · US FDA — Medical DevicesClass II
PRO+ 36" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and outpu - 2026-08-18 · US FDA — Medical DevicesClass II
Intrapulmonary Percussive Ventilation, IPV HC, Product Number: S00009; Phasitron, P5-HC - 2026-08-18 · US FDA — Medical DevicesClass II
Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, GYN LAPAROSCOPY NEW HAN , Catalog Number: - 2026-08-18 · US FDA — Medical DevicesClass II
Intrapulmonary Percussive Ventilation, IPV-2C, Product Number: S00002-C; Phasitron 5, Product Number: P5 used with Inst - 2026-08-18 · US FDA — Medical DevicesClass II
Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT,GU DAVINCI , Catalog Number: - 2026-08-18 · US FDA — Medical DevicesClass II
In-Line Valve, Product Number: P5-TEE - 2026-08-18 · US FDA — Medical DevicesClass II
Impulsator, Product Number: S00010, Phasitron 5, Product Number: P5 used with Instruction Manual - 2026-08-18 · US FDA — Medical DevicesClass II
Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, LAVH , Catalog Number: - 2026-08-18 · US FDA — Medical DevicesClass II
CHARLOTTE CLAW Screw, REF: 40122716, intended for use with CLAW II Polyaxial Compression Plating System - 2026-08-18 · US FDA — Medical DevicesClass II
Travel Air, Product Number: S00055; Phasitron 5, Product Number: P5 used with Instruction Manual - 2026-08-18 · US FDA — Medical DevicesClass II
Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, LAP CHOLE , Catalog Number: - 2026-08-18 · US FDA — Medical DevicesClass II
Intrapulmonary Percussive Ventilation, IPV-1C, Product Number: S00002-C; Phasitron 5, Product Number: P5 used with Inst - 2026-08-18 · US FDA — Medical DevicesClass II
Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065; Phasitron 5 Breathing Circuit with Unified Connec - 2026-08-18 · US FDA — Medical DevicesClass II
The ABL90 FLEX and ABL90 FLEX PLUS analyzers are intended for use by trained technologists, nurses, physicians and thera - 2026-08-14 · US FDA — Medical DevicesClass I
Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories MDR107000P BED, MANUAL, MEDLITE - 2026-08-14 · US FDA — Medical DevicesClass II
Brand Name: Performance Pro Product Name: Performance Pro Model/Catalog Number: 72-RM50601,72-RM50602, 72-RM50603,72-R - 2026-08-14 · US FDA — Medical DevicesClass I
Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories, Hand Pendants: MDR510094 PENDANT F/ MDR107002E - 2026-08-14 · US FDA — Medical DevicesClass II
Brand Name: Opportunity Flex Product Name: Opportunity Flex Model/Catalog Number: 72-50900, 72-50901, 72-50902, 72-509 - 2026-08-14 · US FDA — Medical DevicesClass II
Brand Name: Opportunity Pro Product Name: Opportunity Pro Model/Catalog Number: 72-50800, 72-50801,72-50802,72-50803,7 - 2026-08-14 · US FDA — Medical DevicesClass II
Rollator, Bariatric, Basic Steel, Blue, mechanical walker with four legs and a metal frame intended for medical purposes - 2026-08-14 · US FDA — Medical DevicesClass II
Rollator, Bariatric, Basic Steel, Burgundy, mechanical walker with four legs and a metal frame intended for medical purp - 2026-08-14 · US FDA — Medical DevicesClass II
Techno-Path Multichem AE Unassayed Level 2 REF: AE622X - 2026-08-14 · US FDA — Medical DevicesClass II
Techno-Path Multichem AE Unassayed Level 1 REF:AE621X - 2026-08-14 · US FDA — Medical DevicesClass II
Techno-Path Multichem AE Unassayed Level 3, REF:AE623X - 2026-08-12 · US FDA — Medical DevicesClass II
Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with an inert additive to yield a de - 2026-08-12 · US FDA — Medical DevicesClass II
DxU 840m Iris, REF: C76947; DxU 850m Iris, REF: C49513 - 2026-08-12 · US FDA — Medical DevicesClass II
Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with an inert additive to yield a d - 2026-08-12 · US FDA — Medical DevicesClass II
IQ200 SPRINT, REF: 700-3322,700-3322RFB, 700-3325, 700-3326, B48997; IQ200 SELECT, REF: 700-3340, 700-3345, 700-3347, B - 2026-08-11 · US FDA — Medical DevicesClass I
Medline Convenience Kits: 1) DYKM1000B, Catalog Number: DYKM1000B; 2) DYKM2187A, Catalog Number: DYKM2187A - 2026-08-11 · US FDA — Medical DevicesClass I
Medline Convenience Kits: 1) KIT ANESTHESIA L&D A- LINE SET, Catalog Number: DYKMBNDL199A - 2026-08-11 · US FDA — Medical DevicesClass I
Medline Convenience Kits: 1) DYNDH1193, Catalog Number: DYNDH1193; 2) DYNDH1487A, Catalog Number: DYNDH1487A - 2026-08-11 · US FDA — Medical DevicesClass I
Medline Convenience Kits: 1) OPEN HEART ADULT, Catalog Number: CDS840396Y; 2) FULL LINE ANEURYSM CDS, Catalog Number: - 2026-08-11 · US FDA — Medical DevicesClass I
Medline Convenience Kits: 1) DYNDB3086D, Catalog Number: DYNDB3086D; 2) DYNDB3100, Catalog Number: DYNDB3100; 3) DYNDH - 2026-08-11 · US FDA — Medical DevicesClass I
Medline Convenience Kits: 1) ACC010308A, Catalog Number: ACC010308A; 2) ACC010374A, Catalog Number: ACC010374A; 3) - 2026-08-11 · US FDA — Medical DevicesClass I
Medline Convenience Kits: 1) PORT ACCESS KIT UNIV OF ALA, Catalog Number: DYKM1414; 2) ARTERIAL LINE ST JOES SYR PACK - 2026-08-11 · US FDA — Medical DevicesClass I
INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set. Stay-Flex tubing component. 5 units per box. Mod - 2026-08-11 · US FDA — Medical DevicesClass I
INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set. Stay-Flex tubing component. 5 units per box. Model Nu - 2026-08-11 · US FDA — Medical DevicesClass II
Computed Tomography X-ray System, Model: uCT 530 with software - 2026-08-11 · US FDA — Medical DevicesClass II
Computed Tomography X-ray System, Model: uCT 550 with software - 2026-08-11 · US FDA — Medical DevicesClass II
Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama 35 with software