Browse recalls
Alert level: Class I
- 2026-04-21 · US FDA — Medical DevicesClass I
Description/REF: PSI KIT: 7 FR X 4 IN/ASK-09701-UP; PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-09803-OSU5; PSI KIT: 8.5 FR/A - 2026-04-21 · US FDA — Medical DevicesClass I
Description/REF: CVC KIT: 16 GA X 8IN/AK-04210, CVC KIT: 1-L 16 GA X 8IN (20 CM)/AK-04300, CVC KIT: 14 GA X 6 IN/CK-0471 - 2026-04-21 · US FDA — Medical DevicesClass I
Description/REF: RA CATH KIT: 20 GA X 1 3/4 IN/TJ-04020-1; RA CATH KIT: 20 GA X 1 1/2IN/NA-04220-S1A; ARTERIAL LINE K - 2026-04-21 · US FDA — Medical DevicesClass I
Description/REF: PSI KIT: 7 FR X 4IN ANTIMICROBIAL/ASK-09701-UMH; PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-09803-OSU4; - 2026-04-21 · US FDA — Medical DevicesClass I
Description/REF: DRAINAGE KIT/AK-01600, DRAINAGE KIT/AK-01601, DRAINAGE KIT/ASK-01601-MM, THORACENTESIS KIT/AK-01000-T, - 2026-04-21 · US FDA — Medical DevicesClass I
PARACENTESIS KIT, REF: AK-00376, ASK-00376-VCU - 2026-04-21 · US FDA — Medical DevicesClass I
Description/REF: PACING PSI KIT: 6 FR/AI-06210-KS, PACING PSI KIT: 5 FR 2-L/AI-07155-KS, PACING PSI KIT: 5 FR 2L/ASK- - 2026-04-21 · US FDA — Medical DevicesClass I
Description/REF: PI PICC: 3: 6FR x 55CM w CHG/ DLX-35563-HPKC; AGBA PICC: 2L 5.5 FR X 45 CM/ASK-44552-ABKB; AGBA PICC/DE - 2026-04-21 · US FDA — Medical DevicesClass I
Description/REF: PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PNHS2; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-PNHS2; - 2026-04-21 · US FDA — Medical DevicesClass I
Description/REF: HEMODIALYSIS KIT: 2-LUMEN 8 FR X 11 CM/AK-11802-F; HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-22122; - 2026-04-21 · US FDA — Medical DevicesClass I
Description/REF: AGBA PICC G4 Stylet: 3L 6FR x 55CM BP/DLX-45563-VPSB; AGBA PICC G4 Stylet: 3L 6FR x 55CM TCG/DLX-4556 - 2026-04-20 · US FDA — Medical DevicesClass I
Automated Impella Controller (AIC); Product Code: 0042-0000-US; - 2026-04-10 · US FDA — Medical DevicesClass I
Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter: REF: ACS-15192-VFI, ACS-15232-VFI, ACS-15272-VFI, CS-151 - 2026-04-10 · US FDA — Medical DevicesClass I
Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I - 2026-04-10 · US FDA — Medical DevicesClass I
NextStep Antegrade Chronic Hemodialysis Catheter, REF: AC-15192-SFX, AC-15232-SFX, CS-15192-SFX, CS-15232-SFX, CS-15272- - 2026-04-10 · US FDA — Medical DevicesClass I
Cannon II Plus Hemodialysis Catheter, REF: CS-15242-VSP, CS-15282-VSP, CS-15322-VSP, CS-15362-VSP, CS-15552-VSP, CSD-152 - 2026-04-02 · US FDA — Medical DevicesClass I
Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating Adapter (Namic RA S - 2026-03-27 · US FDA — Medical DevicesClass I
AIDBAGs are first aid kits of convenience composed of individually labeled devices designed as specialty first aid kits - 2026-03-25 · US FDA — Medical DevicesClass I
VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000 - 2026-03-19 · US FDA — Medical DevicesClass I
Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P EL, Model Number U125; 2. VA - 2026-03-19 · US FDA — Medical DevicesClass I
Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor CORONARY ANGIO PACK Mo - 2026-03-19 · US FDA — Medical DevicesClass I
Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardiac Re-Synchronization Therapy) labeled as - 2026-03-12 · US FDA — Medical DevicesClass I
Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7 - 2026-02-18 · US FDA — Medical DevicesClass I
Handy Solutions Neck & Shoulders Heating Pad, Number: 25607, Manufactured by Ninbo Unico Products Co., Ltd - 2026-02-13 · US FDA — Medical DevicesClass I
CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/A, CENFP31K - 2026-02-13 · US FDA — Medical DevicesClass I
ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-NE5/C, DC21454035/C, - 2026-02-13 · US FDA — Medical DevicesClass I
16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/B - 2026-02-13 · US FDA — Medical DevicesClass I
BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU, H965103028031/A, H965103028031/EU, H96 - 2026-02-06 · US FDA — Medical DevicesClass I
Owner's Booklets and Instructions for Use that are used with the following blood glucose measurement devices. Descripti - 2026-02-06 · US FDA — Medical DevicesClass I
Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description - 2026-02-06 · US FDA — Medical DevicesClass I
Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description - 2025-12-22 · US FDA — Medical DevicesClass I
Reprocessed Abbott Inquiry Steerable Diagnostic Catheters: Abbott Inquiry Steerable Diagnostic Catheter 10 Elec. 2- - 2025-12-22 · US FDA — Medical DevicesClass I
Medline ReNewal Reprocessed Webster CS Catheters: Webster CS Catheter 10 Electrodes 2-8-2mm Spacing w/AutoID w/ EZ St - 2025-12-22 · US FDA — Medical DevicesClass I
Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters: ACUSON AcuNav Ultrasound Catheter, Use on GE Syste - 2025-12-22 · US FDA — Medical DevicesClass I
Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Catheters: St. Jude Medical Supreme Diagnostic - 2025-12-19 · US FDA — Medical DevicesClass I
HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Material Number (UPN): M00553520; - 2025-12-19 · US FDA — Medical DevicesClass I
AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Material Number (UPN): M00553660; - 2025-12-19 · US FDA — Medical DevicesClass I
*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; Material Number (UPN): M00553560; - 2025-12-19 · US FDA — Medical DevicesClass I
AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Material Number (UPN): M00553680; - 2025-11-26 · US FDA — Medical DevicesClass I
MEDLINE beds labeled as: Full Electric Lightweight Homecare Bed, REF MDR107003L - 2025-11-26 · US FDA — Medical DevicesClass I
MEDLINE beds labeled as: Full Electric Low Basic Homecare Bed, REF MDR107003ELO - 2025-11-26 · US FDA — Medical DevicesClass I
MEDLINE beds labeled as: 1) Full Electric Basic Homecare Bed, REF MDR107003E; 2) Full Electric Basic Homecare Bed, 4-pac - 2025-11-26 · US FDA — Medical DevicesClass I
MEDLINE beds labeled as: Full Electric Low Lightweight Homecare Bed, REF MDR107003LO - 2025-11-26 · US FDA — Medical DevicesClass I
MEDLINE beds labeled as: Semi Electric Lightweight Homecare Bed, REF MDR107002L - 2025-11-14 · US FDA — Medical DevicesClass I
GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 610 A1, REF 1012-9620-222; - 2025-10-27 · US FDA — FoodClass I
Whatcom Blue Sliced cheese; Sliced and packaged in deli plastic wrap with Whole Foods Scale labels. - 2025-10-27 · US FDA — FoodClass I
Whatcom Farmhouse- Sliced and packaged in deli plastic wrap with Whole Foods Scale labels. - 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, - 2025-10-10 · 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 - 2025-10-02 · 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 - 2025-09-30 · 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 I
IMRIS Operating Suite, InVision 3T Operating Suite, containing Siemens 3 Tesla MRI Magnet, Vida - 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) - 2025-09-09 · US FDA — Medical DevicesClass I
NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I - 2025-08-28 · US FDA — Medical DevicesClass I
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K1 - 2025-08-28 · US FDA — Medical DevicesClass I
Biograph mMR. Model Number: 10433372. - 2025-08-28 · US FDA — Medical DevicesClass I
MAGNETOM Verio. Model Number: 10276755. - 2025-08-28 · US FDA — Medical DevicesClass I
MAGNETOM Lumina (DE). Model Number: 11344916. - 2025-08-28 · US FDA — Medical DevicesClass I
MAGNETOM Spectra as the following: 1. MAGNETOM Spectra. Model Number: 10837643. 2. MAGNETOM Spectra (CN). Model Numbe - 2025-08-28 · US FDA — Medical DevicesClass I
MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217. - 2025-08-28 · US FDA — Medical DevicesClass I
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, - 2025-08-28 · US FDA — Medical DevicesClass I
MAGNETOM Vida Fit. Model Number: 11410481. - 2025-08-28 · US FDA — Medical DevicesClass I
MAGNETOM Skyra fit. Model Number: 10849580. - 2025-08-28 · US FDA — Medical DevicesClass I
MAGNETOM Cima.X (DE). Model Number: 11647158. - 2025-08-28 · US FDA — Medical DevicesClass I
Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6 Pro Android US CGM App Model - 2025-08-28 · US FDA — Medical DevicesClass I
MAGNETOM Verio Dot Upgrade. Model Number: 10684334. - 2025-08-20 · US FDA — Medical DevicesClass I
Model Number L211 PROPONENT DR SL MRI Pacemaker - 2025-08-20 · US FDA — Medical DevicesClass I
Model Number S702, ALTRUA 2 DR SL Pacemaker - 2025-08-20 · US FDA — Medical DevicesClass I
Model Number U128, VALITUDE CRT-P EL MRI - 2025-08-20 · US FDA — Medical DevicesClass I
Automated Impella Controller (AIC) with the below brands and product codes. Used with heart assist pump. 1. Impella Co - 2025-08-20 · US FDA — Medical DevicesClass I
Model Number L231, PROPONENT DR EL MRI Pacemaker - 2025-08-20 · US FDA — Medical DevicesClass I
Model Number L101, ESSENTIO DR SL Pacemaker - 2025-08-20 · US FDA — Medical DevicesClass I
Model Number L209 PROPONENT DR (VDD) SL Pacemaker - 2025-08-20 · US FDA — Medical DevicesClass I
Model Number U226, VISIONIST CRT-P EL - 2025-08-20 · US FDA — Medical DevicesClass I
PROPONENT SR SL (Model L200) - 2025-08-20 · US FDA — Medical DevicesClass I
Model Number U228, VISIONIST CRT-P EL MRI - 2025-08-20 · US FDA — Medical DevicesClass I
Model Number L221 PROPONENT DR EL Pacemaker - 2025-08-20 · US FDA — Medical DevicesClass I
Model Number L131, ESSENTIO DR EL MRI Pacemaker - 2025-08-20 · US FDA — Medical DevicesClass I
ACCOLADE DR EL MRI (Model L331) - 2025-08-20 · US FDA — Medical DevicesClass I
Model Number L121 ESSENTIO DR EL Pacemaker - 2025-08-04 · US FDA — Medical DevicesClass I
Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pump - 2025-08-04 · US FDA — Medical DevicesClass I
Novum IQ LVP (Large Volume Pump), Product Code 40700BAXUS, infusion pump - 2025-07-31 · US FDA — Medical DevicesClass I
Reprocessed Livewire Steerable Electrophysiology Catheter Item Numbers 401575RH 401582RH 401600RH 401603RH 401606 - 2025-07-31 · US FDA — Medical DevicesClass I
Reprocessed Webster CS Catheter 10 Electrodes for electrophysiological mapping of cardiac structures. Medline Item Numbe - 2025-07-31 · US FDA — Medical DevicesClass I
Reprocessed Inquiry Steerable Diagnostics Catheter for electrogram recording and cardiac stimulation during diagnostic e - 2025-07-29 · US FDA — Medical DevicesClass I
WATCHMAN TruSeal Access System SGL, US, Material Number (UPN) M635TU70010; intended to provide vascular and transseptal - 2025-07-29 · US FDA — Medical DevicesClass I
WATCHMAN FXD Curve Access System Dbl, US, Material Number (UPN) M635TU80020; intended to provide vascular and transsepta - 2025-07-29 · US FDA — Medical DevicesClass I
WATCHMAN TruSeal Access System DBL, US, Material Number (UPN) M635TU70020; intended to provide vascular and transseptal - 2025-07-29 · US FDA — Medical DevicesClass I
WATCHMAN FXD Curve Access Sys Sgl, OUS, Material Number (UPN) M635TS80010; intended to provide vascular and transseptal - 2025-07-29 · US FDA — Medical DevicesClass I
WATCHMAN TruSeal Access System DBL, OUS, Material Number (UPN) M635TS70020; intended to provide vascular and transseptal - 2025-07-29 · US FDA — Medical DevicesClass I
WATCHMAN FXD Curve Access Sys Dbl, OUS, Material Number (UPN) M635TS80020; intended to provide vascular and transseptal - 2025-07-24 · US FDA — Medical DevicesClass I
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM Android App Model/Catalog Numbe - 2025-07-24 · US FDA — Medical DevicesClass I
Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ Android CGM App Model/Catalog N - 2025-07-24 · US FDA — Medical DevicesClass I
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Numbe - 2025-07-24 · US FDA — Medical DevicesClass I
Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog Numbe