July 30, 2025Medical DevicesFDA
CooperVision, Inc. recalls Biofinity Toric Multifocal Contact Lens
Hazard: Lens blisters may have an incomplete or leaking seal which may render them unsterile.
July 30, 2025Medical DevicesFDA
CooperVision, Inc. recalls Biofinity XR Toric Contact Lens
Hazard: Lens blisters may have an incomplete or leaking seal which may render them unsterile.
July 30, 2025Medical DevicesFDA
Johnson & Johnson Vision Care, Inc. recalls ACUVUE¿ OASYS MAX 1-Day MULTIFOCAL
Hazard: Due to defects (bubbles/voids) identified during standard finished goods testing
July 30, 2025Medical DevicesFDA
Becton Dickinson & Co. recalls BD COR System Software. Model Number: 444829.
Hazard: Potential for functionality issue that supports the Over labeling feature and could lead to possible false negative results.
July 30, 2025Medical DevicesFDA
Bridge to Life Ltd recalls Bridge to Life EasiSlush, (Sodium Chloride Solution for Sterile Slush Preparation) (0.9% Sodium Chloride Irrigation, USP
Hazard: The 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.
July 30, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: C-SECTION PREP, REF DYNJ32702B
Hazard: Affected 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.
July 30, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: 1) BLOOD CULTURE KIT, REF DYND
Hazard: Affected 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.
July 30, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: IV START KIT LAB DRAW-SH, REF
Hazard: Affected 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.
July 30, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: LABOR TRIAGE KIT, REF DYKM1564
Hazard: Affected 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.
July 30, 2025Medical DevicesFDA
Beckman Coulter Inc. recalls Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of estrone in human serum and pl
Hazard: 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.
July 30, 2025Medical DevicesFDA
Covidien recalls Covidien Nellcor Bedside SpO2 Patient Monitoring System: REF: PM100N, 10005941, DLPM100N, DL10005941, DSPM100N, 10005941
Hazard: Bedside SpO2 Patient Monitoring System alarms not heard/recognized, resulting in: treatment delay, lack of low oxygen saturation response, respiratory failure, arrhythmia. Highlighting operator's manual: 1)For patient Safety don't silence/decrease alarm volume, 2)Sensor off alarm (no perfusion detected) is low priority alarm, 3)Set monitors to Homecare Mode outside of hospital/professional setting
July 30, 2025Medical DevicesFDA
Jinan Bodor Cnc Machine Co Ltd recalls Bodor's I series laser cutting machine.
Hazard: The Bodor i Series products fail to meet certain applicable Federal standards, 21 CFR 1040.10(f)(1) and 21 CFR 1040.10(f)(2).
July 30, 2025Medical DevicesFDA
Encore Medical, LP recalls Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD42 Model/Catal
Hazard: Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued discovered via a customer complaint.
July 30, 2025Medical DevicesFDA
Encore Medical, LP recalls Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 Model/Catal
Hazard: Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued discovered via a customer complaint.
July 30, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls Cone with Male Tubing, Non-Locking, Ellik Evacuator. Model Number: 191-NRS. The Ellik Evacuator and adapter accessor
Hazard: Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
July 30, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls Ellik Evacuator Adapter, Locking. Model Number: 190-NRS. The Ellik Evacuator and adapter accessories are compatible
Hazard: Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
July 30, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls Ellik Latex Bulb, Ellik Evacuator. Model Number: 194-2. The Ellik Evacuator and adapter accessories are compatible w
Hazard: Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
July 30, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls Ellik Evacuator. Model Number: 194. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite
Hazard: Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
July 30, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls Tubing for Male Connector 194, Ellik Evacuator. Model Number: 190-4. The Ellik Evacuator and adapter accessories are
Hazard: Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
July 30, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls Glass Body For 194 Ellik Evacuator. Model Number: 190A. The Ellik Evacuator and adapter accessories are compatible w
Hazard: Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
July 30, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls Green Silicone Seal for Accessories, Reusable Silicone Seal 0 - 7 FR. Model Number: CS-G7. The reusable silicone se
Hazard: Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
July 30, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls Blue Silicone, Reusable Silicone Seal 6 - 12 FR. Model Number: CS-B612. The reusable silicone seals fit over the b
Hazard: Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
July 30, 2025Medical DevicesFDA
Natus Neurology DBA Excel Tech., Ltd. (XLTEK) recalls Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph
Hazard: Natus received two complaints of left side labeling show impedance for right side.
July 30, 2025Medical DevicesFDA
CooperSurgical, Inc. recalls Endosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV. Endosee System Convenience Kit with IV Tube.
Hazard: 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.
July 30, 2025Medical DevicesFDA
CooperSurgical, Inc. recalls Endosee System Convenience Kit. Model Number: ES-TRAY. Endosee System Convenience Kit
Hazard: 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.
July 30, 2025Medical DevicesFDA
CooperSurgical, Inc. recalls HSG Procedure Tray. Model Number: 6050T. The HSG Procedure Tray is for use in hysterosalpingography and sonohysterog
Hazard: 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.
July 30, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 7 M20. Fluoroscopic X-Ray System.
Hazard: Potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose.
July 30, 2025Medical DevicesFDA
GE Medical Systems, LLC recalls SIGNA PET/MR
Hazard: GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual.
July 30, 2025Medical DevicesFDA
GE Medical Systems, LLC recalls Discovery MR750w 3.0T
Hazard: GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual.
July 30, 2025Medical DevicesFDA
GE Medical Systems, LLC recalls SIGNA Architect AIR
Hazard: GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual.