Medical Device Recalls
RSS ↗7,959 medical device recalls from federal enforcement feeds.
Showing 3,001–3,050 of 7,959
- Class II
Medical Device Recall · June 11, 2025
CT DAVINCI. Medical convenience kit.CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
- Class II
Medical Device Recall · June 11, 2025
GYN LAPAROSCOPY PACK. Medical convenience kit.CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
- Class II
Medical Device Recall · June 11, 2025
ROBOTIC PROSTATECTOMY PACK. Medical convenience kit.CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
- Class II
Medical Device Recall · June 11, 2025
LAPAROSCOPY PACK. Medical convenience kit.CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
- Class II
Medical Device Recall · June 11, 2025
CARDIAC ROBOT PACK. Medical convenience kit.CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
- Class II
Medical Device Recall · June 11, 2025
DAVINCI TRUCUSTOM BUNDLE. Medical convenience kit.CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
- Class II
Medical Device Recall · June 11, 2025
LAP CHOLE PACK. Medical convenience kit.CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
- Class II
Medical Device Recall · June 11, 2025
GENERAL LAPAROSCOPY TRAY. Medical convenience kit.CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
- Class II
Medical Device Recall · June 11, 2025
LAPAROSCOPIC GYN. Medical convenience kit.CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
- Class II
Medical Device Recall · June 11, 2025
GS ENDOSCOPY PACK. Medical convenience kit.CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
- Class II
Medical Device Recall · June 11, 2025
LAPAROSCOPIC PROSTATECTOMY. Medical convenience kit.CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
- Class II
Medical Device Recall · June 11, 2025
PARTIAL NEPHRECTOMY - ROBOTIC. Medical convenience kit.CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
- Class II
Medical Device Recall · June 11, 2025
Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution (32 sachets Solution A Phosphate, 32 sachets Solution B Calcium)Out of specification stability test result for the Caphosol B solution from process validation lots
- Class II
Medical Device Recall · June 11, 2025
LAPAROSCOPIC TRAY. Medical convenience kit.CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
- Class II
Medical Device Recall · June 11, 2025
Endosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV. Endosee System Convenience Kit with IV Tube.The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, however the peel away lid labels incorrectly identify the iodine pouches as sterile.
- Class II
Medical Device Recall · June 11, 2025
FUJIFILM Healthcare Americas Corporation
ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).Devices had an unapproved slabbing software function enabled for use.
- Class II
Medical Device Recall · June 10, 2025
Model Number SM-32HF-B-D-C; 32KW 50G, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
Model Number 40KWFXPLUS.005, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
SM_40HF_BDC3, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
Model Number 40KWFXPLUS.004, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
Sedecal Mobile Digital Diagnostic X-Ray Systems; SM-40HF-B-D-KM (AeroDR X30)Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
Model Number SM-40HF-B-D-C; 40KW CANON READY, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
Model Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
Model Number 40KWFX, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
Model SM-40HF-B-D-C; 40KW 70C, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
Model Number 40KWFXPLUS-710CW, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
Model Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
SED URS LP, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
Model Number SM-20HF-Batt; 20KW ANALOG, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
VersaCross Access Solution (VXSK), Product Description and ID: VXSK (180J RF WIRE 63CM/45DEG/D0) VXSK0101 VXSK (180J RF WIRE 63CM/45DEG/D1) VXSK0102 VXSK (180J RF WIRE 63CM/55DEG/D0) VXSK0103Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potential punctures may go undetected in clinical settings due to small size and variable location.
- Class II
Medical Device Recall · June 10, 2025
SM_40HF_B_D_VIR3, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
Model Number SM-40HF-B-D-C; 40KW 50C, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
VersaCross Transseptal Sheath Kit (VXS) Product Description/IDs VXS0201 VXS 63CM/45DEG/D0 SHEATH VXS2112 VERSACROSS SHEATH (63CM 45DEG D0)-J Used for the percutaneous introduction of variousPotential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potential punctures may go undetected in clinical settings due to small size and variable location.
- Class II
Medical Device Recall · June 10, 2025
SHIMADZU RF.004, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
Model Number SM-40HF-B-D-C; 40KW 70C EN, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
Model Number SM-40HF-B-D-C; 40KW CANON READY.005, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
Model Number SM-40HF-B-D-C; 40KW 70C READY, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
SM_40HF_B_D_VIR3.004, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
Model Number 40KWFXPLUS-710CW.007, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
Model SM-40HF-B-D-C; 40KW - CANON READY, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
Model Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
Model Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
Ortho-Clinical Diagnostics, Inc.
VITROS Chemistry Products CHE Slides (Japan); Catalog Numbers: (1) 684 4074 (90 slides), (2) 684 4138 (300 slides);Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs when the PVs are used 2-7 days after reconstitution; however, the label stability claims for the PV fluids is 7 days following reconstitution. This may lead to inaccurate QC results. The use of the PVs when the QC results are outside of the customer s established ranges could result in delayed results for patients due to the need to repeat QC testing or reconstitute new PV fluids and repeat testing. It could also result in erroneous patient results (small positive bias).
- Class II
Medical Device Recall · June 10, 2025
Ortho-Clinical Diagnostics, Inc.
Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier I Model/Catalog Number: 806 7324 Software Version: Not Applicable Product Description: VITROS CheQuality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs when the PVs are used 2-7 days after reconstitution; however, the label stability claims for the PV fluids is 7 days following reconstitution. This may lead to inaccurate QC results. The use of the PVs when the QC results are outside of the customer s established ranges could result in delayed results for patients due to the need to repeat QC testing or reconstitute new PV fluids and repeat testing. It could also result in erroneous patient results (small positive bias).
- Class II
Medical Device Recall · June 10, 2025
Model Number SM-40HF-B-D-C; 40KW 55G/60G, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
Model Number SM-40HF-B-D-C; 40KW70CDEMO.005, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
Ortho-Clinical Diagnostics, Inc.
VITROS Chemistry Products CHE Slides; Catalog Numbers: (1) 191 4605 (300 slides), (2) 800 4707 (90 slides);Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs when the PVs are used 2-7 days after reconstitution; however, the label stability claims for the PV fluids is 7 days following reconstitution. This may lead to inaccurate QC results. The use of the PVs when the QC results are outside of the customer s established ranges could result in delayed results for patients due to the need to repeat QC testing or reconstitute new PV fluids and repeat testing. It could also result in erroneous patient results (small positive bias).
- Class II
Medical Device Recall · June 10, 2025
Model SM-32HF-Batt; 32KW ANALOG, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.