FDA Enforcement · Jun 10, 2026
Device recall: Covidien Mon-a-Therm General Purpose Temperature Probe REF: 90044
Temperature probe devices lack FDA clearance. — Covidien LLC · Class II · Ongoing
Latest medical news · page 199
The latest headlines across every section, pulled from official and open-access sources.
FDA Enforcement · Jun 10, 2026
Device recall: Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM REF: 90042
Temperature probe devices lack FDA clearance. — Covidien LLC · Class II · Ongoing
FDA Enforcement · Jun 10, 2026
Device recall: Arvis Hip & Knee 2.0 Instrument Set, REF: IN-21200 containing one of the following components: IN-10500,…
The Impactor V-Block Assembly and Trackers A, B, C and E may exhibit signs of early wear and/or corrosion on the exposed magnet face. — Kico Knee Innovation Company · Class II · Ongoing
FDA Enforcement · Jun 10, 2026
Device recall: Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;
The presence of holes in the pouch may compromise the package s ability to maintain the sterile barrier and protect the product from environmental exposure. — Covidien, LP · Class II · Ongoing
FDA Enforcement · Jun 10, 2026
Device recall: Philips Azurion 7B20/15, Model Numbers: 722068, 722226 with Software release R2.2.0, R2.2.1, R2.2.3,…
During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run. — PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Class II · Ongoing
FDA Enforcement · Jun 10, 2026
Device recall: BD¿Spinal Tray with BD¿Whitacre Needle 24 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%)…
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing. — Becton Dickinson & Company · Class I · Ongoing
FDA Enforcement · Jun 10, 2026
Device recall: Atlan A350. Model Number: 8211500. anesthesia workstation
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use. — Draeger, Inc. · Class I · Ongoing
FDA Enforcement · Jun 10, 2026
Device recall: CASE v7.0 Cardiac Testing System Model no. 3031234-001 Product Code SU3
Electrical sparking may occur at the printer head. If the Electrostatic Discharge (ESD) printer brush becomes dislodged, electrical sparking at the printer head can result in charring or discoloration of thermal printer paper. Ignition of the paper could potentially result in serious thermal injury. — GE Medical Systems Information Technologies Inc · Class II · Ongoing
FDA Enforcement · Jun 10, 2026
Device recall: Brand Name: B. BRAUN MEDICAL INC. Product Name: LYNDON B JOHNSON HOSPITAL SPINAL EPID Model/Catalog…
B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable. — B Braun Medical Inc · Class II · Ongoing
FDA Enforcement · Jun 10, 2026
Device recall: BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%)…
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing. — Becton Dickinson & Company · Class I · Ongoing
FDA Enforcement · Jun 10, 2026
Device recall: BD Pyxis MedBank Mini REF: 1147-00 Medication cabinet
Fingerprint scanner may overheat to a temperature to cause 1st degree burn. — CareFusion 303, Inc. · Class II · Ongoing
FDA Enforcement · Jun 10, 2026
Device recall: LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.
Potential software anomaly that can cause the pump to report a false battery-health value (typically 69%) and trigger a battery-depletion alarm that will shut down the pump unless it is reconnected to AC mains power. — Fresenius Kabi USA, LLC · Class I · Ongoing
FDA Enforcement · Jun 10, 2026
Device recall: Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK RIVERSIDE HEALTH SYSTEM Model/Catalog Number: 552126…
B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable. — B Braun Medical Inc · Class II · Ongoing
FDA Enforcement · Jun 10, 2026
Device recall: Aligned Medical AMS16835 Fluids Kit RX
Lidocaine Hydrochloride Injection, USP, which was recalled by a supplier for quality issues, was included in custom convenience kits. — Windstone Medical Packaging, Inc. · Class II · Ongoing
FDA Enforcement · Jun 10, 2026
Device recall: Brand Name: B. BRAUN MEDICAL INC. Product Name: SESK UPMC DOUBLE CATHETER TRAY Model/Catalog Number:…
B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable. — B Braun Medical Inc · Class II · Ongoing
FDA Enforcement · Jun 10, 2026
Device recall: Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP may cause damage to internal components that may not be apparent or readily visible and the devices therefore remained in service. More specifically, drops or jarring on a hard surface can cause the touchscreen input cable to loosen, resulting in u… — Fresenius Kabi USA, LLC · Class I · Ongoing
FDA Enforcement · Jun 10, 2026
Device recall: BD Pyxis MedStation ES Tower REF: 352 Medication cabinet
Fingerprint scanner may overheat to a temperature to cause 1st degree burn. — CareFusion 303, Inc. · Class II · Ongoing
FDA Enforcement · Jun 10, 2026
Device recall: Design Options Spinal Tray Spinal Needle Anesthesia procedure kits: Material Description (Material…
These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huon Co, Ltd., has issued a voluntary recall due to potential quality issues identified during a recent FDA manufacturing facility inspection. — B Braun Medical Inc · Class I · Ongoing
FDA Enforcement · Jun 10, 2026
Device recall: Philips Azurion 5M12, Model Numbers: 722227 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and…
During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run. — PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Class II · Ongoing
FDA Enforcement · Jun 10, 2026
Device recall: Brand Name: Exacta Mix Product Name: Vented Micro-Volume Inlet Model/Catalog Number: H938175 Product…
Affected lots may contain incorrect 0.8-micron filters. Use of a 0.8-micron filter in place of the validated 3-micron filter may lead to reduced flow efficiency, incomplete or slower transfers of ingredients, or system alarms. This issue may lead to clinical effects such as electrolyte imbalance, metabolic instability, delayed recovery, etc. — Baxter Healthcare Corporation · Class II · Ongoing
FDA Enforcement · Jun 10, 2026
Food recall: Lunds & Byerly's Curry Powder Sweet
Sesame Seeds White were labeled as Curry Powder Sweet. — J and J Bunting, Inc · Class II · Ongoing · 144 units (bottles)
FDA Enforcement · Jun 10, 2026
Food recall: STRAUS FAMILY CREAMERY Cookie Dough ORGANIC SUPER PREMIUM ICE CREAM ONE PINT (473mL) Produced and
Potential contamination with foreign objects (metal pieces). — Straus Family Creamery · Class II · Ongoing · 547.375 cases (8 units/case)
FDA Enforcement · Jun 10, 2026
Food recall: White Cheddar Seasoning
Products may be potentially contaminated with Salmonella. — JCB Flavors, LLC · Class I · Ongoing · 5200 jars total
FDA Enforcement · Jun 10, 2026
Food recall: Aramark Cheese Sauce New & Improved, 25 lb.
Product contains dry milk powder ingredient recalled by the supplier due to potential Salmonella contamination — The Coffee Connexion Co., Inc · Class I · Ongoing · 10,958 cases