FDA Device · 2025
FDA Device recalls in 2025
RecallRadar indexes 2,908 FDA Device recall notices published in 2025. By classification: 380 Class I, 2,433 Class II, 95 Class III.
- Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 22714183-5 Software Version: N/A Product Description: Ball…
FDA Device · Class I · 2025-04-23 · Avanos Medical - Medline Convenience kits used for various procedures: 1) RHINOPLASTY PACK, Model Number: DYNJ84116A
FDA Device · Class II · 2025-04-23 · Medline Industries Northfield - Medline Convenience kits used for various procedures: 1) SKIN LESION SET, Model Number: MNS6270
FDA Device · Class II · 2025-04-23 · Medline Industries Northfield - Welch Allyn CONNEX Accessory Power Management Stand
FDA Device · Class II · 2025-04-23 · Baxter Healthcare - Welch Allyn Spot Vital Signs 4400 Device, Product Code/Part Numbers: 1) 44WT-2
FDA Device · Class II · 2025-04-23 · Baxter Healthcare - Venue Go Models: R2 (Model Number H45181VG), R3 (Model Number H45193VG), R4 (Model Number H45114VG), R5 (Model Numbers H45135VG, H45135VGW)…
FDA Device · Class II · 2025-04-23 · Ge Medical Systems - Medline Convenience kits used for various procedures: 1) ANGIOGRAPHY DRAPE PACK, Model Number: HCP075G
FDA Device · Class II · 2025-04-23 · Medline Industries Northfield - Medline Convenience kits used for various procedures: 1) ANGIO CONSOLIDATED PACK, Model Number: DYNJHTCAD1
FDA Device · Class II · 2025-04-23 · Medline Industries Northfield - Guide Wire with Ruler Tube 3x1000 mm DIA
FDA Device · Class II · 2025-04-23 · Stryker - Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T Model/Catalog Number: 427-000 Software Version: N/A Product…
FDA Device · Class II · 2025-04-23 · Abbott Diagnostics Scarborough - Medline Convenience kits used for various procedures: 1) INTUBATION TRAY, Model Number: MNS10395
FDA Device · Class II · 2025-04-23 · Medline Industries Northfield - Medline Convenience kits used for various procedures: 1) CUSTOM BLOCK KEMP PACK-LF, Model Number: DYNJ0371999G
FDA Device · Class II · 2025-04-23 · Medline Industries Northfield - Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 198 Software Version: N/A Product Description: Ballard Clo…
FDA Device · Class I · 2025-04-23 · Avanos Medical - Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code: 05415067040725 REF LSP112V UDI-DI code: 05415067034472 The Ave…
FDA Device · Class II · 2025-04-23 · Abbott Medical - HeartMate Mobile Power Unit: REF: 107754, NA
FDA Device · Class I · 2025-04-23 · Thoratec - Medline Convenience kits used for various procedures: 1) LARGE BIOPSY PACK NTX, Model Number: DYNJ68393A
FDA Device · Class II · 2025-04-23 · Medline Industries Northfield - Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV35 Product Description: Rover Mobile X-rays System ("Rover"…
FDA Device · Class II · 2025-04-23 · Micro X - Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 220135 Software Version: N/A Product Description: Ballard…
FDA Device · Class I · 2025-04-23 · Avanos Medical - Philips DXR System, DuraDiagnost Rel. 4. Stationary X-Ray System
FDA Device · Class II · 2025-04-23 · Philips North America - Medline Convenience kits used for various procedures: 1) STANDARD D&C, Model Number: DYNJ69733
FDA Device · Class II · 2025-04-23 · Medline Industries Northfield - Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A Product Description: Respirator…
FDA Device · Class II · 2025-04-23 · Abbott Diagnostics Scarborough - Medline Convenience kits used for various procedures: 1) MINOR BASIN -SMH, Model Number: DYNJ907733B
FDA Device · Class II · 2025-04-23 · Medline Industries Northfield - Medline Convenience kits used for various procedures: 1) LINE INSERTION PACK, Model Number: DYNJ44949C
FDA Device · Class II · 2025-04-23 · Medline Industries Northfield - Medline Convenience kits used for various procedures: 1) CSTM PACEMAKER DRAPE PACK, Model Number: DYNJCD0339
FDA Device · Class II · 2025-04-23 · Medline Industries Northfield - Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A Product Description: Respirator…
FDA Device · Class II · 2025-04-23 · Abbott Diagnostics Scarborough - Medline Convenience kits used for various procedures: 1) ED CRASH C-SECTION TRAY, Model Number: MNS13635A
FDA Device · Class II · 2025-04-23 · Medline Industries Northfield - Refer to RES
FDA Device · Class II · 2025-04-23 · Medline Industries Northfield - Medline Convenience kits used for various procedures: 1) BASIC CATARACT, Model Number: DYNJ41097A
FDA Device · Class II · 2025-04-23 · Medline Industries Northfield - Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T Model/Catalog Number: 427-000 Software Version: N/A Product…
FDA Device · Class II · 2025-04-23 · Abbott Diagnostics Scarborough - BD 4 Fr Single-Lumen PowerPICC Catheters, REF: 3174155, CK000540, 3174118, CK000483, 3174335, 3174355, CK000196, 9174118, CK000955, 3174135…
FDA Device · Class I · 2025-04-23 · Bard Access Systems - Medline Convenience kits used for various procedures: 1) UTHET TYLER OB PACK, Model Number: DYNJ68673
FDA Device · Class II · 2025-04-23 · Medline Industries Northfield - Refer to RES
FDA Device · Class II · 2025-04-23 · Medline Industries Northfield - Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2210-5 Software Version: N/A Product Description: Ballard…
FDA Device · Class I · 2025-04-23 · Avanos Medical - Welch Allyn Connex Integrated Wall System, Product Code/Part Numbers: 1) 84MTVE2-4
FDA Device · Class II · 2025-04-23 · Baxter Healthcare - Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 210 Software Version: N/A Product Description: Ballard Clo…
FDA Device · Class I · 2025-04-23 · Avanos Medical - Medline Convenience kits used for various procedures: 1) NEURO PACK WRO-LF, Model Number: DYNJ41856C
FDA Device · Class II · 2025-04-23 · Medline Industries Northfield - Medline Convenience kits used for various procedures: 1) OCULOPLASTIC PICK PACK, Model Number: DYNJ43914B
FDA Device · Class II · 2025-04-23 · Medline Industries Northfield - Welch Allyn CP150 Electrocardiograph
FDA Device · Class II · 2025-04-23 · Baxter Healthcare - restor3d Cordera Hip System
FDA Device · Class II · 2025-04-23 · Conformis - Medline Convenience kits used for various procedures: 1) UNIVERSAL DRAPE PACK, Model Number: DYNJCD0239
FDA Device · Class II · 2025-04-23 · Medline Industries Northfield - Welch Allyn Connex Vital Signs Monitor (CVSM)
FDA Device · Class II · 2025-04-23 · Baxter Healthcare - Medline Convenience kits used for various procedures: 1) NAIL PACK, Model Number: SUT15830A
FDA Device · Class II · 2025-04-23 · Medline Industries Northfield - TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel
FDA Device · Class II · 2025-04-23 · Straumann Usa - Medline Convenience kits used for various procedures: 1) HERNIA REPAIR TOTE, Model Number: DYNJ908337C
FDA Device · Class II · 2025-04-23 · Medline Industries Northfield - Medline Convenience kits used for various procedures: 1) CW PERI GYN, Model Number: DYNJ80807B
FDA Device · Class II · 2025-04-23 · Medline Industries Northfield - Medline Convenience kits used for various procedures: 1) LABOR AND DELIVERY PACK-LF, Model Number: DYNJ26971L
FDA Device · Class II · 2025-04-23 · Medline Industries Northfield - Welch Allyn Connex Vital Signs Monitor, Product Code/Part Numbers: 1) ) Product Code/Part # 67MXTP-B-ECG3A
FDA Device · Class II · 2025-04-23 · Baxter Healthcare - Medline Convenience kits used for various procedures: 1) PRECIP TRAY, Model Number: MNS12590
FDA Device · Class II · 2025-04-23 · Medline Industries Northfield - Philips DXR System, DuraDiagnost 4.1. Stationary X-Ray System
FDA Device · Class II · 2025-04-23 · Philips North America - Medline Convenience kits used for various procedures: 1) T A PACK, Model Number: DYNJ67791A
FDA Device · Class II · 2025-04-23 · Medline Industries Northfield - Welch Allyn Welch Allyn Connex Spot Monitor, Product Code/ Part Numbers: 1) 73WT-B
FDA Device · Class II · 2025-04-23 · Baxter Healthcare - Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71 Product Description: Rover Mobile X-rays System ("Rover"…
FDA Device · Class II · 2025-04-23 · Micro X - Medline Convenience kits used for various procedures: 1) RHINOPLASTY PACK, Model Number: DYNJ27333F
FDA Device · Class II · 2025-04-23 · Medline Industries Northfield - Venue Fit Models: R3 (Model Number H45303VFSC, H45303VFSW), R4 (Model Number H45314VFS, H45314VFSW), Venue Fit R5 system (Model Numbers H45…
FDA Device · Class II · 2025-04-23 · Ge Medical Systems - Medline Convenience kits used for various procedures: 1) IV PACK SOUTH, Model Number: DYNJ88422
FDA Device · Class II · 2025-04-23 · Medline Industries Northfield - Welch Allyn 2-Piece Reusable Blood Pressure Cuff Kits labeled as: 1. WELCH ALLYN 2-Piece Reusable Blood Pressure Cuff Kits, Product Code/Pa…
FDA Device · Class II · 2025-04-23 · Baxter Healthcare - Welch Allyn DuraShock Aneroid Gauge Sets with a Reusable Blood Pressure Cuff labeled as: 1) WELCH ALLYN DURASHOCK Aneroid Gauge Sets with a…
FDA Device · Class II · 2025-04-23 · Baxter Healthcare - Medline Convenience kits used for various procedures: 1) PAIN PACK, Model Number: DYNJ67577A
FDA Device · Class II · 2025-04-23 · Medline Industries Northfield - Medline Convenience kits used for various procedures: 1) T&A ENDO PACK, Model Number: DYNJ59620A
FDA Device · Class II · 2025-04-23 · Medline Industries Northfield - Medline Convenience kits used for various procedures: 1) DR. KHAN CABG ADDS PACK, Model Number: DYNJ59310D
FDA Device · Class II · 2025-04-23 · Medline Industries Northfield - Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog Number: 192-000 Software Version: N/A Product Descr…
FDA Device · Class II · 2025-04-23 · Abbott Diagnostics Scarborough - Medline Convenience kits used for various procedures: 1) DENTAL PACK-LF, Model Number: DYNJ84880
FDA Device · Class II · 2025-04-23 · Medline Industries Northfield - Welch Allyn Green Series 777 Wall System, Product Code/Part Numbers: 1) 77791-2MP2X
FDA Device · Class II · 2025-04-23 · Baxter Healthcare - Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2271418-5 Software Version: N/A Product Description: Balla…
FDA Device · Class I · 2025-04-23 · Avanos Medical - Tandem Mobi Insulin Pump with Interoperable Technology
FDA Device · Class I · 2025-04-23 · Tandem Diabetes Care - Guide Wire with Ruler Tube 3x800 mm DIA
FDA Device · Class II · 2025-04-23 · Stryker - Medline Convenience kits used for various procedures: 1) PERI GYN PACK, Model Number: DYNJ80786
FDA Device · Class II · 2025-04-23 · Medline Industries Northfield - t:slim X2 Insulin Pump with Interoperable Technology
FDA Device · Class I · 2025-04-23 · Tandem Diabetes Care - Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog Number: 192-000 Software Version: N/A Product Descr…
FDA Device · Class II · 2025-04-23 · Abbott Diagnostics Scarborough - Medline Convenience kits used for various procedures: 1) ARTHROSCOPIE DU GENOU-LF, Model Number: DYNJ40229A
FDA Device · Class II · 2025-04-23 · Medline Industries Northfield - Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 20083 Software Version: N/A Product Description: Ballard C…
FDA Device · Class I · 2025-04-23 · Avanos Medical - MEDFLEX, REF: 1119-00
FDA Device · Class II · 2025-04-23 · Carefusion 303 - Brand Name: Cerene Cryotherapy Device Product Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL Model/Catalog Number: FGS-7000 Product Descriptio…
FDA Device · Class II · 2025-04-23 · Channel Medsystems - Maquet VH-3010 Power Supply
FDA Device · Class II · 2025-04-23 · Maquet Cardiovascular - Atellica CH Revised C Reactive Protein (RCRP)
FDA Device · Class II · 2025-04-16 · Siemens Healthcare Diagnostics - stryker Blueprint Mixed Reality Box Base, Catalog Number MRUE204, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Numbe…
FDA Device · Class II · 2025-04-16 · Tornier S - stryker Blueprint Mixed Reality Depth Stop Pin, Catalog Number MRUE206
FDA Device · Class II · 2025-04-16 · Tornier S - Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis Pro (Model 977118) n…
FDA Device · Class II · 2025-04-16 · Medtronic Neuromodulation - MEDLINE ReNewal Coblator II Evac 70 Xtra Plasma Wand,w/Integrated Saline Line & Integrated Cable, Item Number REF EICA58720R
FDA Device · Class II · 2025-04-16 · Medline Industries Northfield - IVX Station Reconstitution Transfer Set
FDA Device · Class II · 2025-04-16 · Omnicell - Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CABG OPNHRT S HSP, CARDIAC CABG, CARDIAC PACK…
FDA Device · Class I · 2025-04-16 · Medline Industries Northfield - stryker HoloBlueprint Application, Catalog Number MRUE001
FDA Device · Class II · 2025-04-16 · Tornier S - stryker Blueprint Mixed Reality Coracoid Clamp, Catalog Number MRUE202, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog…
FDA Device · Class II · 2025-04-16 · Tornier S - BD Pyxis MedBank CUBIE Replenishment Station Product / Material ID BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P / 155141-01 BD PYXIS MEDBANK TWR M…
FDA Device · Class II · 2025-04-16 · Carefusion 303 - Wayson Hydrocolloid Models: 1) Model Number: CUR5103, DBD-BNDG,WTRPRF,HYDRCLLD,CLR,2.36X3.93", 2) Model Number: MJ18004, DBD-MEIJER,BANDAGE…
FDA Device · Class II · 2025-04-16 · Medline Industries Northfield - Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: TOL DR R PACK
FDA Device · Class I · 2025-04-16 · Medline Industries Northfield - stryker Blueprint Mixed Reality Instrument Check Block, Catalog Number MRUE203, packaged in stryker Blueprint Mixed Reality Instrument Kit,…
FDA Device · Class II · 2025-04-16 · Tornier S - MEDLINE ReNewal Coblator II ENT Evac 70 Xtra HP,w/Integrated Cable (Blue/Grey), Number REF EICA58740R
FDA Device · Class II · 2025-04-16 · Medline Industries Northfield - Hippo 072 Aspiration System including Cheetah Delivery Tool and Aspiration Tubing, REF: APT6072-132
FDA Device · Class I · 2025-04-16 · Qapel Medical - Medline medical convenience kits labeled as: 1) NEONATAL INTUBATION TRAY, REF ACC010371C
FDA Device · Class I · 2025-04-16 · Medline Industries Northfield - Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: HEART BASIN PACK-LF
FDA Device · Class I · 2025-04-16 · Medline Industries Northfield - Wayson Hydrocolloid Models: 1) MJ BANDAGE HYDROCOLLOID HEEL OVAL 6CT, Model Number: MJ18004V2
FDA Device · Class II · 2025-04-16 · Medline Industries Northfield - FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374
FDA Device · Class II · 2025-04-16 · Biofire Diagnostics - MEDLINE ReNewal ENT Coblator II PROcise XP Wand,w/Integrated Cable Suction & Saline (Blue), Item Number REF EICA88720R
FDA Device · Class II · 2025-04-16 · Medline Industries Northfield - stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN
FDA Device · Class II · 2025-04-16 · Tornier S - stryker Blueprint Mixed Reality Glenoid Box Lid, Catalog Number MRUE205, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalo…
FDA Device · Class II · 2025-04-16 · Tornier S - GenetiSure Dx Labeling Kit, REF: K1201-64105, contains human reference DNA female aliquot, REF5190-7317
FDA Device · Class II · 2025-04-16 · Agilent Technologies - stryker Blueprint Mixed Reality Glenoid Digitizer, Catalog Number MRUE201, packaged in stryker Blueprint Mixed Reality Instrument Kit, Cata…
FDA Device · Class II · 2025-04-16 · Tornier S - BD Pyxis" MedBank" Mini and BD Pyxis" MedBank" Tower, BD Pyxis" MedFlex, BD Pyxis" MedBank" MedPass are automated dispensing cabinets (ADC)…
FDA Device · Class II · 2025-04-16 · Carefusion 303 - Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CPB ADJUNCT PACK, DR. C PACK, PK CUST CV A&B…
FDA Device · Class I · 2025-04-16 · Medline Industries Northfield
Other years
2026 (2,024) · 2025 (2,908) · 2024 (3,393) · 2023 (2,477) · 2022 (2,191) · 2021 (2,303) · 2020 (3,055) · 2019 (2,801) · 2018 (3,757) · 2017 (2,615) · 2016 (3,246) · 2015 (2,495) · 2014 (3,059) · 2013 (2,249) · 2012 (1,310)