
FDA•CRITICAL
Epidural/Pain TQC Kit
Medical Action recalls its Epidural/Pain TQC Kit containing sodium chloride ampules over compromised sterility.
2 products
Medical Action recalls its Epidural/Pain TQC Kit containing sodium chloride ampules over compromised sterility.
2 products
Boston Scientific recalls ENROUTE Transcarotid Neuroprotection System over sheath tip separation risk.
2 products
BMC recalls Luna G3 APAP (REF LG 3600) over 2024 warehouse rework.

Spectra Medical Devices recalls Elevaris Sodium Chloride Injection 10mL Ampules over sterility concerns.

Baxter recalls Duo-Vent Solution Set (1C8507) over air bubble risk in drip chamber and tubing.

Boston Scientific recalls Infinion CX lead kits for SCS systems due to possible lead fracture at anchor site.

AVID Medical recalls Halyard kits with Medline manifolds due to particulate risk.
3 products
Bard Access recalls BD Powered Driver Needle Kits over obturator removal difficulty.

Angiography kit manifolds recalled due to particulate risk in blood circulation.

ResMed recalls Astral 100/150 ventilators due to supercapacitor leakage that may interrupt ventilation.

Medline is recalling anterior hip kits containing Bupivacaine Hydrochloride in Dextrose Injection over quality issues.
4 products
Medline is recalling specific lots of procedure kits containing Bupivacaine ampules due to a quality issue that could cause drug ineffectiveness.
4 products
Oscor recalls Abiomed Impella Introducer Kit (14F) due to sheath leakage risk.
3 products
Argon recalls Transvenous Pacing Electrode Trays due to non-sterile lidocaine ampules in kits.
6 products
Abiomed recalls Impella RP Flex introducers over sheath leakage risk.
13 products
Medline is recalling reprocessed catheters due to residual particulate matter that may cause infection or embolism.

Medtronic is recalling the Harmony Delivery Catheter System due to a manufacturing defect that may cause the distal tip to detach during use.

DSAEK Pack-RX kits recalled due to contaminated alcohol prep pads; stop use and contact firm.
4 products
Baxter recalls Hillrom Volara P.CIRCUIT KIT (REF M08085) due to nebulizer cup leakage causing oxygen drop and ineffective treatment.
4 products
Hamilton Medical is recalling ventilator coaxial breathing circuits due to a risk of valve membrane adhesion and inadequate ventilation.

Abiomed recalls Impella CP introducer kit (14 Fr x 13 cm) over thrombus risk.
4 products
Medline recalls CV Anesthesia Room Setup kits due to quality issues with included lidocaine and bupivacaine injections.
5 products
Datex-Ohmeda recalls Giraffe infant resuscitation systems over oxygen concentration risk.
3 products
Abiomed is recalling Impella CP Sets with SmartAssist due to a risk of low purge pressure that may interrupt mechanical circulatory support.
