Category

Medical Devices Recalls

15,654 medical devices recalls on record from CPSC, FDA, and USDA.

15,654 recalls
High RiskFDA
Ad-tech Medical Instrument Corporation
Ad-Tech Lightweight TECH ATTACH Cable - Product Usage: Designed for the purpose of connecting these electrodes to third party monitors/st...
Medical Devices·10 affected·Aug 9, 2021
High RiskFDA
Convatec, Inc
DuoDERM CGF Dressing 10x10CM (1x5PK) (ICC 187660) DuoDERM Extra Thin Dressing 15X15CM (1X10PK) (ICC 187957) DuoDERM Extra Thin Dressing...
Medical Devices·2,734,830 affected·Aug 9, 2021
High RiskFDA
Smiths Medical Asd Inc.
Bivona Aire-Cuf Endotracheal Tube
Medical Devices·7,136 affected·Aug 9, 2021
High RiskFDA
Ad-tech Medical Instrument Corporation
Ad-Tech Lightweight CABRIO Cable - Product Usage: Designed for the purpose of connecting these electrodes to third party monitors/stimula...
Medical Devices·69 affected·Aug 9, 2021
High RiskFDA
Ge Healthcare, Llc
Centricity Universal Viewer and Viewer 6.0 - Product Usage: Is a device that displays medical images (including mammograms) and data from...
Medical Devices·462 affected·Aug 6, 2021
High RiskFDA
Zoll Circulation, Inc.
Zoll, REF 8700-000871-40, Quattro (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer
Medical Devices·579 affected·Aug 6, 2021
High RiskFDA
Zoll Circulation, Inc.
Zoll, REF 8700-000866-01, ICY IVTM Disposable Pack and Start UP Kit (6 ft.)
Medical Devices·42 affected·Aug 6, 2021
High RiskFDA
Medline Industries Inc
NAMIC Stopcocks: (1) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015002, UPN H965700150021, Three-way Stopcock with Rotating Collar, Rx on...
Medical Devices·816,420 affected·Aug 6, 2021
High RiskFDA
Ge Healthcare, Llc
Centricity PACS-IW with Universal Viewer - Product Usage: Is a device that displays medical images (including mammograms) and data from v...
Medical Devices·392 affected·Aug 6, 2021
High RiskFDA
Intuitive Surgical, Inc.
Ion Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm, Ref: 490104-09 and 49004-10, 5-pack, Sterile EO, Rx only, UDI:00886874115978
Medical Devices·1,625 affected·Aug 6, 2021
High RiskFDA
Zoll Circulation, Inc.
Zoll, REF 8700-000870-40, ICY (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer
Medical Devices·1,122 affected·Aug 6, 2021
High RiskFDA
Zoll Circulation, Inc.
Zoll, REF 8700-000865-01, Cool Line IVTM Disposable Pack and Start UP Kit (6 ft.)
Medical Devices·55 affected·Aug 6, 2021
High RiskFDA
Zoll Circulation, Inc.
Zoll, REF 8700-000867-01, Quattro IVTM Disposable Pack and Start UP Kit (6 ft.)
Medical Devices·334 affected·Aug 6, 2021
CriticalFDA
Smiths Medical Asd Inc.
NORMOFLO Irrigation Warming administration set (disposable), Models IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700
Medical Devices·519,250 affected·Aug 6, 2021
High RiskFDA
C.r. Bard Inc
Catalog A319416AM, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, Temperature Sensing, StatLock" Stabilization Device
Medical Devices·5,950 affected·Aug 5, 2021
High RiskFDA
C.r. Bard Inc
Catalog A899916, SureStep" Foley Tray, Lubricath", Drainage Bag, StatLock" Stabilization Device
Medical Devices·960 affected·Aug 5, 2021
High RiskFDA
M.d.l. S.r.l.
Soft Tissue Biopsy Needles
Medical Devices·20,129 affected·Aug 5, 2021
High RiskFDA
M.d.l. S.r.l.
Mammary Nodules Localization
Medical Devices·320 affected·Aug 5, 2021
High RiskFDA
C.r. Bard Inc
Catalog A942216, SureStep" Foley Tray, Bard LubricathTM, Urine Meter, StatLock" Stabilization Device
Medical Devices·1,440 affected·Aug 5, 2021
High RiskFDA
C.r. Bard Inc
Catalog A897514, SureStep" Foley Tray, Silicone, Drainage Bag, StatLock" Stabilization Device
Medical Devices·1,710 affected·Aug 5, 2021
High RiskFDA
C.r. Bard Inc
Catalog A902616, SureStep" Foley Tray, Bardex" I.C., Lubricath", Urine Meter
Medical Devices·80 affected·Aug 5, 2021
High RiskFDA
C.r. Bard Inc
Catalog A119216M, SureStep" Foley Tray, Lubri-Sil", Urine Meter, Temperature Sensing Dual, StatLock" Stabilization Device
Medical Devices·10,150 affected·Aug 5, 2021
CriticalFDA
Armstrong Medical Services Limited
AMSORB PLUS PREFILLED G-CAN 1.0L; Carbon dioxide absorbent canister; Product codes AMAB3801 and AMAB3801GE. Used in anesthesia.
Medical Devices·214,032 affected·Aug 5, 2021
High RiskFDA
C.r. Bard Inc
Catalog A303318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, StatLock" Stabilization Device
Medical Devices·420 affected·Aug 5, 2021
High RiskFDA
C.r. Bard Inc
Catalog A300318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device
Medical Devices·350 affected·Aug 5, 2021
High RiskFDA
C.r. Bard Inc
Catalog A303316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, StatLock" Stabilization Device
Medical Devices·11,600 affected·Aug 5, 2021
High RiskFDA
C.r. Bard Inc
Catalog A943216, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabilization Device
Medical Devices·40 affected·Aug 5, 2021
CriticalFDA
Cardinal Health
Monoject 0.9% Sodium Chloride Flush Syringe, 5mL Fill, STERILE, Product Code 8881570125 The proposed device is indicated for use in f...
Medical Devices·267,217,860 affected·Aug 4, 2021
CriticalFDA
Cardinal Health
Monoject 0.9% Sodium Chloride Flush Syringe, 3 mL Fill, STERILE, Product Code 8881570123 The proposed device is indicated for use in ...
Medical Devices·267,217,860 affected·Aug 4, 2021
High RiskFDA
Roche Molecular Systems, Inc.
cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190
Medical Devices·211 affected·Aug 4, 2021
CriticalFDA
Cardinal Health
Monoject 0.9% Sodium Chloride Flush Syringe, 10 mL Fill, STERILE, Product Code 8881570121 The proposed device is indicated for use in...
Medical Devices·267,217,860 affected·Aug 4, 2021
High RiskFDA
Abbott Molecular, Inc.
Vysis CLL FISH Probe Kit with the following components: Vysis LSI p53 SpectrumOrange/ATM, SpectrumGreen and LSI D13S319, SpectrumOrange/ ...
Medical Devices·186 affected·Aug 4, 2021
High RiskFDA
Olympus Corporation Of The Americas
Arc Endocuff Vision as follows: ARV110 ENDOCUFF-V M BLUE PK8, Part Number: E0420501; ARV120 ENDOCUFF-V L GREEN PK8, Part Number: E0420...
Medical Devices·711,157 affected·Aug 3, 2021
High RiskFDA
Fresenius Medical Care Holdings, Inc.
AquaBplus Water Purification System, Part Number 24-2000-0, AquaBplus 2500 - Typ USA (G02040108-US), AquaBplus 2000 - Typ USA (G02040114-...
Medical Devices·2 affected·Aug 3, 2021
High RiskFDA
Carefusion
BD Gravity Burette Set 60 DROP 1.2 MF 2 SmartSite VALVES BALL VALVE DRIP CHAMBER V/NV, REF: 10037031; BD Gravity Burette Set 20 DROP 1.2 ...
Medical Devices·77,802 affected·Aug 2, 2021
High RiskFDA
Carefusion
BD Gravity IV Set 3-port Closed Manifold Back Check Valve 3 Needle-Free Y-sites, REF: CM42500E-07; BD Gravity IV Set 3-port Closed Stopoc...
Medical Devices·24,360 affected·Aug 2, 2021
High RiskFDA
Carefusion
BD SE Burette Set 20 Drops 2 Injection Ports Vented/NonVented, REF: 72103E-0006
Medical Devices·56,680 affected·Aug 2, 2021
High RiskFDA
Carefusion
BD Alaris Pump Infusion Buerette Set 0.2 Micron Filter Smallbore Tubing SmartSite Port (Burette) SmartSite Y-Site, REF: 10015012; BD Alar...
Medical Devices·344,300 affected·Aug 2, 2021
High RiskFDA
Shanghai United Imaging Healthcare Co., Ltd.
uEXPLORER PET/CT System - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, locali...
Medical Devices·1 affected·Aug 2, 2021
High RiskFDA
Carefusion
BD Extension Set SMALLBORE Tubing with 2 SmartSite VALVES, REF: 20019E
Medical Devices·1,463,647 affected·Aug 2, 2021
High RiskFDA
Carefusion
BD SmartSite Bag Access Device, REF: 2300E-0500; BD BAG ACCESS DEVICE CHECK VALVE SmartSite VALVE, REF: 2309E
Medical Devices·708,910 affected·Aug 2, 2021
High RiskFDA
Carefusion
BD SmartSite 'Y' Extension Set 2 Needle-Free Valves, REF: 20019E7D
Medical Devices·1,839,594 affected·Aug 2, 2021
High RiskFDA
Carefusion
BD BURETTE GRAVITY SET 60 DROP 2 Smartsite VALVES VENTED/NONVENTED, REF: 42163E
Medical Devices·630 affected·Aug 2, 2021
High RiskFDA
Carefusion
BD SmartSite, REF: 2000E CHINA; BD SmartSite Connector, REF: 2000E-04; BD SmartSite J-LOOP Extension Set One Needle Free Valve, REF: 2002...
Medical Devices·23,786,178 affected·Aug 2, 2021
High RiskFDA
Ge Healthcare, Llc
Flow sensors that may be installed in the following GEHC anesthesia machines: (1) Aestiva MRI, GTIN 0080682102339; (2) Aestiva 7900; ...
Medical Devices·310,072 affected·Aug 2, 2021
High RiskFDA
Leica Microsystems, Inc.
BOND Ready-To-Use Primary Antibody CDX2 (EP25), REF PA0375
Medical Devices·237 affected·Jul 30, 2021
High RiskFDA
Paragon 28, Inc.
Phantom Nail System, Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection p28 P99-110-4630
Medical Devices·14 affected·Jul 30, 2021
High RiskFDA
Hitachi Healthcare Americas Corporation
OASIS MRI System
Medical Devices·472 affected·Jul 29, 2021