December 24, 2025Medical DevicesFDA
Rocket Medical Plc recalls Brand Name: Rocket Product Name: Rocket 16Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54549-16-PK Sof
Hazard: IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
December 24, 2025Medical DevicesFDA
Rocket Medical Plc recalls Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter with Safety Guard Model/Catalog Number: R54544-18-SG
Hazard: IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
December 24, 2025Medical DevicesFDA
Rocket Medical Plc recalls Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54544-18-PK Sof
Hazard: IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
December 24, 2025Medical DevicesFDA
Rocket Medical Plc recalls Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter with Safety Guard Model/Catalog Number: R54544-12-SG
Hazard: IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
December 24, 2025Medical DevicesFDA
Rocket Medical Plc recalls Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54544-12-PK Pro
Hazard: IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
December 24, 2025Medical DevicesFDA
DSAART LLC recalls Brand Name: AART Calf Implant Product Name: Calf Implant Model/Catalog Number: 502-103 - Calf Implant style 1 size 3
Hazard: Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
December 24, 2025Medical DevicesFDA
DSAART LLC recalls Brand Name: AART Pectoral Implant Product Name: Pectoral Implant Model/Catalog Number: 500-106-5 Pectoral Implant sty
Hazard: Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
December 24, 2025Medical DevicesFDA
DSAART LLC recalls Brand Name: AART Malar Implant Product Name: Malar Implant Model/Catalog Number: 401-202-5 Malar Implant style 2 size
Hazard: Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
December 24, 2025Medical DevicesFDA
DSAART LLC recalls Brand Name: AART Chin Implant Product Name: Chin Implant Model/Catalog Numbers: 400-0101 Chin Implant style 1 size 1
Hazard: Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
December 24, 2025Medical DevicesFDA
DSAART LLC recalls Brand Name: AART Gluteal Implant Product Name: Gluteal Implant Model/Catalog Numbers: 501-101 - Gluteal Implant style
Hazard: Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
December 24, 2025Medical DevicesFDA
DSAART LLC recalls Brand Name: AART Silicone Carving Implant Product Name: Silicone Carving Implant Model/Catalog Numbers: 600-601 - Silico
Hazard: Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
December 24, 2025Medical DevicesFDA
Copan Italia recalls 1ml of DTT in liquid phase, in PET tube with capture cap, in bulk
Hazard: Treatment reagent functionality in respiratory specimens fluidification cannot be guaranteed.
December 24, 2025Medical DevicesFDA
Copan Italia recalls 1ml of DTT in liquid phase, in PET tube with capture cap, in bulk + sputum transfer device, for WASP* *Compatible wit
Hazard: Treatment reagent functionality in respiratory specimens liquification cannot be guaranteed.
December 24, 2025Medical DevicesFDA
DICOM Grid, Inc. recalls Intelerad InteleShare software, with ProViewer component
Hazard: Software intended to aid in diagnosing conditions, planning treatments, visualizing anatomical structures has a bug that, if all of following are met: Viewing images in InteleShare viewer; Multiplanar reconstruction applied; Manual rotation applied, could result in inaccurate length measurement tool values that could compromise diagnostic accuracy, lead to misdiagnosis or inappropriate follow-up.
December 24, 2025Medical DevicesFDA
PATH recalls MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)
Hazard: Following a component change in the DPOAE probe (speaker replacement), technical distortions may occur at high stimulus levels combined with unusually low OAE amplitude acceptance thresholds. These distortions can mimic true DPOAE responses and may result in a false PASS outcome.
December 24, 2025Medical DevicesFDA
Instrumentation Laboratory recalls HemosIL SynthAFax. Partial Thromboplastin Time Tests.
Hazard: Recalled lots were manufactured with double the amount of preservative concentration.
December 24, 2025Medical DevicesFDA
SEASPINE ORTHOPEDICS CORPORATION recalls Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments: Navigation Driver, REF: PC2-400012; Naviga
Hazard: The NorthStar OCT Navigation Surgical Technique Guide (STG) incorrectly identified both Medtronic s Solera and Medtronic s Infinity system toolcards as compatible with the NorthStar OCT Navigation Instruments. However, the NorthStar OCT Navigation Instruments are compatible for use with Medtronic s Solera toolcards only.
December 24, 2025Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls 5008X CAREsystem +CLiC +CDX;
Hazard: Several software anomalies with the potential to impact patient treatment, of which one includes the possibility to result in treatment stop if certain conditions are fulfilled.
December 24, 2025Medical DevicesFDA
GE Healthcare GmbH recalls GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system
Hazard: GE HealthCare has become aware that the Patient History tab in ViewPoint 6 versions 6.15.3 and 6.15.4 ultrasound software may not include complete patient medical history information.
December 24, 2025Medical DevicesFDA
Datascope Corp. recalls Cardiosave Rescue
Hazard: The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
December 24, 2025Medical DevicesFDA
Datascope Corp. recalls Cardiosave Hybrid
Hazard: The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
December 24, 2025Medical DevicesFDA
AVID Medical, Inc. recalls Halyard, HEAD AND NECK TRAY. Catalog Number: EURO016-09.
Hazard: Potential for incomplete seal on header bag.
December 24, 2025Medical DevicesFDA
AVID Medical, Inc. recalls Halyard, MAJOR PACK. Catalog Number: JEMJ10-01.
Hazard: Potential for incomplete seal on header bag.
December 24, 2025Medical DevicesFDA
AVID Medical, Inc. recalls Halyard, MIDTOWN GENERAL ARTERIOGRAM. Catalog Number: EUHM009-01.
Hazard: Potential for incomplete seal on header bag.
December 24, 2025Medical DevicesFDA
AVID Medical, Inc. recalls Halyard, EP LAB PK. Catalog Number: ESJH009-03.
Hazard: Potential for incomplete seal on header bag.
December 24, 2025Medical DevicesFDA
AVID Medical, Inc. recalls Halyard, GENERAL LAPAROSCOPY PACK. Catalog Number: VAST018-10.
Hazard: Potential for incomplete seal on header bag.
December 24, 2025Medical DevicesFDA
Zimmer Surgical Inc recalls Zimmer Dermatome AN, Model/Catalog Number: 88710100
Hazard: The devices may have a misaligned thickness control bar.
December 24, 2025Medical DevicesFDA
Zimmer Surgical Inc recalls Zimmer Air Dermatome, Model/Catalog Number: 00880100100
Hazard: The devices may have a misaligned thickness control bar.
December 24, 2025Medical DevicesFDA
Medline Industries, LP recalls FORCEP, STD STR, STERILE KELLY, 5.5 IN, Item Number DYNJ04048
Hazard: The items may have weak packaging seals that may result in a breach of sterility if the seal fails and may lead to an increased risk of infection if product is utilized.
December 24, 2025Medical DevicesFDA
Medline Industries, LP recalls SCISSORS, OR, SHARP/BLUNT, 5.5", STERILE, Item Number DYND04000
Hazard: The items may have weak packaging seals that may result in a breach of sterility if the seal fails and may lead to an increased risk of infection if product is utilized.