June 17, 2026Medical DevicesFDA
Avanos Medical, Inc. recalls Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PUSH OTW Model/Catalog Number: 7170-14 Pr
Hazard: Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
June 17, 2026Medical DevicesFDA
Avanos Medical, Inc. recalls Product Name: CORFLO Safety PEG Kit with ENFit Connector Model/Catalog Number: 50-6316 Product Description: Feeding Tu
Hazard: Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
June 17, 2026Medical DevicesFDA
Avanos Medical, Inc. recalls Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-6312
Hazard: Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
June 17, 2026Medical DevicesFDA
Avanos Medical, Inc. recalls Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-5320
Hazard: Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
June 17, 2026Medical DevicesFDA
Avanos Medical, Inc. recalls Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-4320
Hazard: Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
June 17, 2026Medical DevicesFDA
Avanos Medical, Inc. recalls Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6316
Hazard: Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
June 17, 2026Medical DevicesFDA
Avanos Medical, Inc. recalls Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6312
Hazard: Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
June 17, 2026Medical DevicesFDA
Avanos Medical, Inc. recalls Brand Name: CORFLO Product Name: CORFLO Safety PEG Kit Model/Catalog Number: 30-5320
Hazard: Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
June 17, 2026Medical DevicesFDA
Avanos Medical, Inc. recalls Brand Name: CORFLO Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-4320
Hazard: Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
June 17, 2026Medical DevicesFDA
HF Acquisition Co LLC recalls Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS Product Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12
Hazard: Due to incorrect incubation process being performed on product.
June 17, 2026Medical DevicesFDA
HF Acquisition Co LLC recalls Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Product Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52
Hazard: Due to incorrect incubation process being performed on product.
June 17, 2026Medical DevicesFDA
INSPIREMD Inc recalls CGuard¿ Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: CND1040
Hazard: Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
June 17, 2026Medical DevicesFDA
INSPIREMD Inc recalls CGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: CND1030
Hazard: Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
June 17, 2026Medical DevicesFDA
INSPIREMD Inc recalls Brand Name: CGuard Prime Carotid Stent System, 135cm, 9mx40mm Model/Catalog Number: CND0940
Hazard: Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
June 17, 2026Medical DevicesFDA
INSPIREMD Inc recalls CGuard Prime Carotid Stent System, 135cm, 9mx30mm Model/Catalog Number: CND0930
Hazard: Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
June 17, 2026Medical DevicesFDA
INSPIREMD Inc recalls Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND0840
Hazard: Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
June 17, 2026Medical DevicesFDA
INSPIREMD Inc recalls Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx30mm Model/Catalog Number: CND0830
Hazard: Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
June 17, 2026Medical DevicesFDA
D.O.R.C. Dutch Opthalmic Research Center Intl B.V. recalls TDC VELOCE", 27G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT27, 9311.27G01, 9311.27G02, 9311.27K01, 931
Hazard: An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.
June 17, 2026Medical DevicesFDA
D.O.R.C. Dutch Opthalmic Research Center Intl B.V. recalls TDC VELOCE", 25G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT25, 9311.25G01, 9311.25G02, 9311.25K01, 931
Hazard: An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.
June 17, 2026Medical DevicesFDA
D.O.R.C. Dutch Opthalmic Research Center Intl B.V. recalls TDC VELOCE", 23G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT23, 9311.23G01, 9311.23G02, 9311.23K01, 931
Hazard: An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.
June 17, 2026Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G;
Hazard: Given the increased number of leaks reported by users, it was determined to be the appropriate course of action to notify users of the potential for the occurrence of Bicarby luer-lock leaks during manipulation of the frangible and tubing when preparing the product for use for treatment. This issue presents the potential of a slip and fall hazard associated with fluid on the floor.
June 17, 2026Medical DevicesFDA
BERLIN HEART GMBH recalls EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x
Hazard: Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.
June 17, 2026Medical DevicesFDA
Mozarc Medical US LLC recalls Mahurkar Elite PASS Trays; Description (Product Number/CFN): 12 FR x 13cm Acute Dual Lumen Catheter with Straight Exte
Hazard: The Tegaderm CHG dressing, as specified in product labeling, was missing from certain lots of Mahurkar Elite PASS Trays.
June 17, 2026Medical DevicesFDA
GE Medical Systems, LLC recalls Allia Moveo angiographic X-ray system
Hazard: GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.
June 17, 2026Medical DevicesFDA
GE Medical Systems, LLC recalls Allia IGS Pulse angiographic X-ray system
Hazard: GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.
June 17, 2026Medical DevicesFDA
GE Medical Systems, LLC recalls Allia IGS 7 Pulse angiographic X-ray system
Hazard: GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.
June 17, 2026Medical DevicesFDA
GE Medical Systems, LLC recalls Allia IGS 5 Pulse angiographic X-ray system
Hazard: GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.
June 17, 2026Medical DevicesFDA
GE Medical Systems, LLC recalls Allia IGS 3 Pulse angiographic X-ray system
Hazard: GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.
June 17, 2026Medical DevicesFDA
ICU Medical, Inc. recalls Plum Duo Precision IV Pump, 40002-0403
Hazard: Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.
June 17, 2026Medical DevicesFDA
ICU Medical, Inc. recalls Plum Duo Infusion Pump, 40002-0401
Hazard: Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.