Medical Device Recalls
RSS ↗8,689 medical device recalls from federal enforcement feeds.
Showing 3,701–3,750 of 8,689
- Class II
Medical Device Recall · June 12, 2025
Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 Model/Catalog Number: 952-28-40E Software Version: NA Product Description: The EMPOWR DuaDue to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued discovered via a customer complaint.
- Class II
Medical Device Recall · June 12, 2025
MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: LABOR TRIAGE KIT, REF DYKM1564Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by BD due to potential to exhibit an open seal on its packaging. This may constitute a breach to sterility, which may in turn lead to the infection related harms for the patient.
- Class II
Medical Device Recall · June 12, 2025
Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD42 Model/Catalog Number: 952-28-42F Software Version: NA Product Description: The EMPOWR DuaDue to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued discovered via a customer complaint.
- Class II
Medical Device Recall · June 12, 2025
Bridge to Life EasiSlush, (Sodium Chloride Solution for Sterile Slush Preparation) (0.9% Sodium Chloride Irrigation, USP), Part Number REF BTLE-1250The firm issued a field safety notice after becoming aware of three lots of products not having quarterly dose audits being completed on time in the first quarter of 2024. Routine lot by lot testing was completed properly however the quarterly dose audit (sampling/testing to monitor the gamma sterilization process and confirm the validated parameters remain effective to assure sterility and bioburden reduction per requirements) was not completed on time.
- Class II
Medical Device Recall · June 12, 2025
Johnson & Johnson Vision Care, Inc.
ACUVUE¿ OASYS MAX 1-Day MULTIFOCALDue to defects (bubbles/voids) identified during standard finished goods testing
- Class II
Medical Device Recall · June 12, 2025
MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: IV START KIT LAB DRAW-SH, REF CDS860014PAffected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by BD due to potential to exhibit an open seal on its packaging. This may constitute a breach to sterility, which may in turn lead to the infection related harms for the patient.
- Class II
Medical Device Recall · June 12, 2025
Estrone RIA Catalog Number DSL8700 UDI Code: 15099590211615 Estrone RIA is an in vitro diagnostic manual medical device used by healthcare professionals for the quantitative measurement of estroneEstrone RIA kit lots may rarely give falsely high patient results which might cause Temporary injury of Remote probability or rarely give falsely low patient results which might cause Permanent injury of Remote probability. Only in some (very rare) cases may the issue occur.
- Class II
Medical Device Recall · June 12, 2025
Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of estrone in human serum and plasma.A specific lot of bovine serum albumin (BSA) used for manufacturing of coated tubes (CT) that are included in the Estrone RIA kit lots caused different affinity of manufactured coated tubes to patient samples, causing falsely increased assay results for the impacted Estrone RIA kits.
- Class II
Medical Device Recall · June 12, 2025
Ortho-Clinical Diagnostics, Inc.
VITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITROS OP Reagent is a dual-chambered package containing ready-to-use liquid reagents that are used to detect opiates in urine.Lots from Generation (GEN) 15 of VITROS Chemistry Products OP Reagent may generate lower than expected quality control (QC) results. If the customer is unable to get passing quality control results, then the customer would be unable to run the OP-LO protocol leading to a potential delay in patient results.
- 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
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
GS ENDOSCOPY PACK. Medical convenience kit.CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
- Class II
Medical Device Recall · June 11, 2025
HSG Procedure Tray. Model Number: 6050T. The HSG Procedure Tray is for use in hysterosalpingography and sonohysterography procedures.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
GEN LAPAROSCOPY 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
MAJOR THORACOSCOPY BASIN. Medical convenience kit.CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
- Class II
Medical Device Recall · June 11, 2025
PARTIAL NEPHRECTOMY PACK. 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
HVI CARDIAC ROBOT PACK. Medical convenience kit.CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
- Class II
Medical Device Recall · June 11, 2025
GENERAL ROBOTIC PACK. Medical convenience kit.CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
- Class II
Medical Device Recall · June 11, 2025
DA VINCI PACK URO/PROSTATE. 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. Model Number: ES-TRAY. Endosee System Convenience KitThe 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
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 UROLOGY. Medical convenience kit.CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
- Class II
Medical Device Recall · June 11, 2025
ROBOTIC URO/GYN PACK. 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
PACK GENERAL 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
CT DAVINCI. Medical convenience kit.CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
- Class II
Medical Device Recall · June 11, 2025
GYN ROBOTIC 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
GENERAL LAPAROSCOPY 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 11, 2025
LAVH 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
PARTIAL NEPHRECTOMY - ROBOTIC. Medical convenience kit.CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
- 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.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 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
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 40KW-FX.899, 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 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 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
RADPRO MOBILE, 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 40KWMOBILE3.899, 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
BostonSight PROSE Lens.Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both.