Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 103 of 548
FDA Devices Moderate Oct 4, 2023
3M Attest Super Rapid Readout Steam Challenge Pack, REF 1496V; designed to qualify and monitor dynamic-air removal steam sterilization processes
3M Company - Health Care Business
FDA Devices Moderate Oct 4, 2023
Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and 5.0.1 Part Number: LVP-SW-0004. Indicated for use in a hospital and in…
Fresenius Kabi USA, LLC
FDA Devices Moderate Sep 27, 2023
MEDLINE STERILE IRIS SCISSORS CVD/STD, REF DYNJ04049
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Sep 27, 2023
DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106
Encore Medical, LP
FDA Devices Moderate Sep 27, 2023
Patient Information Center iX with Software Version Number 4.x in the following: (1) Patient Information Center iX Product Number: 866389; (2) P…
Philips North America Llc
FDA Devices Moderate Sep 27, 2023
VITROS XT Chemistry Products ALKP Slides
Ortho-Clinical Diagnostics, INc.
FDA Devices Moderate Sep 27, 2023
Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle-Allows the user to mix bone cement witha constant high vacuum throug…
Stryker Corporation
FDA Devices Moderate Sep 27, 2023
Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only
Karl Storz Endoscopy
FDA Devices Moderate Sep 27, 2023
Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter, intravascular
ARROW INTERNATIONAL Inc.
FDA Devices Moderate Sep 27, 2023
APK2 Pressure-Sensing Wheelchair Cushions
Aquila Corporation
FDA Devices Critical Sep 27, 2023
Hamilton C1/T1/MR1, REF: MSP161502/12, Control Board Spare part for ventilator
Hamilton Medical, Inc.
FDA Devices Critical Sep 27, 2023
Hamilton-T1, REF: 161006, Intensive Care and Transport Ventilator
Hamilton Medical, Inc.
FDA Devices Moderate Sep 27, 2023
TyTek Tension Pneumothorax Access Kit TPAK 14 gauge 3.25 inch- Intended for introduction into the body to facilitate removal of air from the pleural …
Tytek Medical Inc
FDA Devices Moderate Sep 27, 2023
Gallant VR Implantable Cardioverter Defibrillator: VR ICD REF CDVRA500Q Gallant DR Implantable Cardioverter Defibrillator: DR ICD REF CDDRA500Q …
Abbott Medical
FDA Devices Moderate Sep 27, 2023
Stryker ACM (Advanced Cement Mixing) System: Break-Away Femoral Nozzle-, Allows the user to mix bone cement with a constant high vacuum through the …
Stryker Corporation
FDA Devices Moderate Sep 27, 2023
Perifix¿ / Epidural anesthesia set, medicated
B. Braun Medical, Inc.
FDA Devices Moderate Sep 27, 2023
Membrane Changer Single-Use, REF MC, each package contains 3 changers; Membrane Changer Reloadable, REF MC-R, each package contains 3 changers; and M…
SenTec AG
FDA Devices Moderate Sep 27, 2023
Stryker ACM (Advanced Cement Mixing): 180-Gram Cement Cartridge with Breakaway Femoral Nozzle-Allows the user to mix bone cement with a constant high…
Stryker Corporation
FDA Devices Moderate Sep 27, 2023
DJO Surgical: Delta Ceramic Femoral Head, 44 mm + 4.0 mm, REF: 400-03-443
Encore Medical, LP
FDA Devices Critical Sep 27, 2023
Hamilton-MR1, REF: 161010, Intensive Care Ventilator
Hamilton Medical, Inc.
FDA Devices Critical Sep 27, 2023
Hamilton-C1, REF: 161001, Portable Intensive Care Ventilator
Hamilton Medical, Inc.
FDA Devices Moderate Sep 27, 2023
Omnipod 5 Automated Insulin Delivery System
Insulet Corporation
FDA Devices Moderate Sep 27, 2023
DJO Surgical: CLP Hip, Stem, Polished Neck, Lateral Offset Implant, Size#3, REF: 426-11-030
Encore Medical, LP
FDA Devices Moderate Sep 27, 2023
DJO Surgical: Reverse Shoulder System (RSP) Semi Humeral Socket Insert, 32mm, REF: 508-01-032; Baseplate, Glenoid HA-Coat, RSP, 6.5mm X 30mm, REF: 50…
Encore Medical, LP
FDA Devices Moderate Sep 27, 2023
COPAN REF: 2U045S01 300uL Transfer Pipette Individually wrapped pipettes, 1000 pcs.
Copan Diagnostics Inc
FDA Devices Critical Sep 27, 2023
Hamilton-T1, REF: MSP161339/02, ESM Shielding Set, Spare Part for ventilator
Hamilton Medical, Inc.
FDA Devices Moderate Sep 27, 2023
Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, and 00-1007, when Used With Tempus Pro Video Laryngosco…
Remote Diagnostic Technologies Ltd.
FDA Devices Critical Sep 27, 2023
Hamilton-T1, REF: 161009, Intensive Care and Transport Ventilator
Hamilton Medical, Inc.
FDA Devices Moderate Sep 27, 2023
Arrow ErgoPack, Pressure Injectable Two-Lumen PICC pre-loaded with Arrow VPS Stylet, REF CDC-35552-VPS; Catheter: Percutaneous, implanted, long-term …
ARROW INTERNATIONAL Inc.
FDA Devices Moderate Sep 27, 2023
PDS Plus Antibacterial (polydioxanone) Suture, Product Numbers PDP072H40, PDP259H50, PDP416H50, PDP441H50, PDP442H50, PDP489G50, PDP489H40, PDP497G51…
ETHICON, LLC
FDA Devices Moderate Sep 27, 2023
VITROS XT Chemistry Products TBIL-ALKP Slides
Ortho-Clinical Diagnostics, INc.
FDA Devices Moderate Sep 27, 2023
Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle, Restrictors & Prox. Med. Press- Allows the user to mix bone cement w…
Stryker Corporation
FDA Devices Moderate Sep 27, 2023
FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size small, Product Code 46827
O&M HALYARD, INC.
FDA Devices Moderate Sep 27, 2023
Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle, Restrictors & Prox. Press-Allows the user to mix bone cement with a …
Stryker Corporation
FDA Devices Moderate Sep 27, 2023
Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle & Solid Blades-Allows the user to mix bone cement with a constant hi…
Stryker Corporation
FDA Devices Moderate Sep 27, 2023
Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press-Allows the user to mix bone cement with a constan…
Stryker Corporation
FDA Devices Moderate Sep 27, 2023
Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model 5875569, used with CardioLab AltiX and ComboLab AltiX.
GE Medical Systems Information Technologies Inc
FDA Devices Moderate Sep 27, 2023
smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee joint
Smith & Nephew Inc
FDA Devices Moderate Sep 27, 2023
TyTek PneumoDart- Intended for introduction into the body to facilitate removal of air from the pleural cavity in patients with a tension pneumothora…
Tytek Medical Inc
FDA Devices Moderate Sep 27, 2023
TyTek Tension Pneumothorax Access Kit TPAK10: 10 gauge, 3.25 inch- Intended for introduction into the body to facilitate removal of air from the pleu…
Tytek Medical Inc
FDA Devices Moderate Sep 20, 2023
nanoDot D2DNS, Model Numbers: a) 18100-000; b) 18100-1MO; c) 18100-2MO; d) 18100-KIT; radiation monitoring dosimeter used with the microSTAR…
Landauer
FDA Devices Moderate Sep 20, 2023
nanoDot D2DNS, Model Numbers: a) 03057-1MO; b) 03057-3MO; c) 03057-OTO; d) 03057-SMO; radiation monitoring dosimeter used with the microST…
Landauer
FDA Devices Moderate Sep 20, 2023
Constancy (80 kVp) nanoDot D2DNN, Model Numbers: a) 18150-000 (EMEA number VKITCON002); b) 18150-KIT; radiation monitoring dosimeter used with t…
Landauer
FDA Devices Critical Sep 20, 2023
Proclaim Plus 5 Implantable Pulse Generator REF 3670 Product Description: The implantable pulse generator (IPG) is an electronic device designed …
Abbott Medical
FDA Devices Critical Sep 20, 2023
Proclaim XR 5 Implantable Pulse Genterator REF 3660 (previously known as Proclaim" 5 Elite IPG) Model 3660 Product Description: The implantable…
Abbott Medical
FDA Devices Moderate Sep 20, 2023
ASG-001; Ultrasound gel
Advance Medical Designs, Inc.
FDA Devices Moderate Sep 20, 2023
QC (80 kVp) screened nanoDot D2DNS, Model Number 03066-OTO; radiation monitoring dosimeter used with the microSTAR readers
Landauer
FDA Devices Moderate Sep 20, 2023
nanoDot A - item 1 of 3 for 03500-000, Model Number 03501-000; radiation monitoring dosimeter used with the microSTAR readers
Landauer
FDA Devices Moderate Sep 20, 2023
Reader, nanoDot adapter, EU Model Number VINLADA003; radiation monitoring dosimeter used with the microSTAR readers
Landauer
FDA Devices Critical Sep 20, 2023
Infinity 5 Implantable Pulse Generator REF 6660 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be…
Abbott Medical