Open, ClassifiedPosted Jun 1, 2026·Initiated Apr 27, 2026
PhaseOne Antimicrobial Solution, Model/Catalog Number: 15050
Reason: The recall is being conducted due to corrosion of the internal metallic spring within the sprayer component. This condition is caused by material incompatibility between the product solution and the stainless steel spring and may result in visible discoloration and the presence of trace levels of metallic elements (including iron, chromium, and nickel) in the solution during use.
Root cause: Component design/selection
Recalling firm: Oculus Technologies of Mexico, S.A. de C.V.Type: Dressing, Wound, DrugDistribution: US Nationwide distribution in the states of AZ, CA, CO, FL, GA, IL, IN, KY, MI, MS, NC, NJ, NY, TN, TX, UT, VA.Recall #Z-2275-2026
Open, ClassifiedPosted Jun 1, 2026·Initiated Apr 24, 2026
CASE v7.0 Cardiac Testing System
Model no. 3031234-001
Product Code SU3
Reason: 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.
Root cause: Process control
Recalling firm: GE Medical Systems Information Technologies IncType: Computer, Diagnostic, ProgrammableDistribution: Worldwide distribution - US Nationwide and the countries of Algeria, Australia, Bangladesh,
Cambodia, Canada, Croatia, Denmark, Finland, France, Germany, Greece, Hong Kong, India,
Indonesia, Ireland, Italy, Japan, South Korea, Lebanon, Libya, Lithuania, Malaysia, Myanmar, Netherlands, New Zealand, Norway, Philippines, Poland, Qatar, Romania, Saudi Arabia, Senegal, Singapore, South Africa, Spain, Sri Lanka, Sweden, Taiwan, Tanzania,
Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom.Recall #Z-2279-2026
Open, ClassifiedPosted Jun 1, 2026·Initiated Apr 15, 2026
Covidien EndoStitch" Polysorb Single Use Loading Unit;
Product numbers: 170053 and 170071;
Reason: 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.
Root cause: Process control
Recalling firm: Covidien, LPType: Endoscopic Tissue Approximation DeviceDistribution: Domestic: Nationwide distribution;
International: Austria, Canada, Denmark, France, Italy;Recall #Z-2281-2026 Open, ClassifiedPosted Jun 1, 2026·Initiated May 6, 2026
Neptune Smart Docking Station (120V), Catalog Number 0770-100-000, part of the Neptune Waste Management System
Reason: It has been identified that the impacted docking station (SN 2521008873) was not product released from manufacturing and may not have completed required testing prior to being shipped to your facility. There is a potential risk of electrical shock due to the device s safety testing being unverifiable.
Root cause: Nonconforming Material/Component
Recalling firm: Stryker CorporationType: Apparatus, Suction, Ward Use, Portable, Ac-PoweredDistribution: US Nationwide distribution in the state of Indiana.Recall #Z-2282-2026
Open, ClassifiedPosted Jun 1, 2026·Initiated Apr 30, 2026
Brand Name: HiResolution" Bionic Ear System
Product Name: HiRes Ultra 3D CI HiFocus Mid Scala
Model/Catalog Number: CI-1601-04
Software Version: N/A
Product Description: The HiResolution Bionic Ear System is a cochlear implant designed to provide useful hearing to individuals with severe-to-profound hearing loss. It consists of internal and external components. The internal components include the HiRes" Ultra 3D receiver and either the HiFocus" SlimJ electrode or the HiFocus" Mid-Scala (MS) electrode array that are implanted surgically under the skin behind the ear. The external components include a sound processor (body-worn or ear-level), a headpiece, and a cable. The system converts sound into electrical energy that activates the auditory nerve. The auditory nerve then sends information to the brain, where it is interpreted as sound.
Component: N/A
Reason: Due to incorrect shelf-life expiration date.
Root cause: Under Investigation by firm
Recalling firm: Advanced Bionics, LLCType: Implant, CochlearDistribution: U.S. Nationwide distribution in the states of CA, CO, GA, IL, IN, KS, MA, MD, MI, MO, MT, NC, TN, WA and WI.Recall #Z-2283-2026 Open, ClassifiedPosted Jun 1, 2026·Initiated Dec 7, 2023
Philips Azurion 3M12, Model Numbers: 722063, 722221 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
Reason: 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.
Root cause: Software design
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Type: Interventional Fluoroscopic X-Ray SystemDistribution: US Nationwide distribution.Recall #Z-2284-2026
Open, ClassifiedPosted Jun 1, 2026·Initiated Dec 7, 2023
Philips Azurion 3M15, Model Numbers: 722064, 722222 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
Reason: 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.
Root cause: Software design
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Type: Interventional Fluoroscopic X-Ray SystemDistribution: US Nationwide distribution.Recall #Z-2285-2026
Open, ClassifiedPosted Jun 1, 2026·Initiated Dec 7, 2023
Philips Azurion 5M12, Model Numbers: 722227 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
Reason: 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.
Root cause: Software design
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Type: Interventional Fluoroscopic X-Ray SystemDistribution: US Nationwide distribution.Recall #Z-2286-2026
Open, ClassifiedPosted Jun 1, 2026·Initiated Dec 7, 2023
Philips Azurion 5M20, Model Numbers: 722228 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
Reason: 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.
Root cause: Software design
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Type: Interventional Fluoroscopic X-Ray SystemDistribution: US Nationwide distribution.Recall #Z-2287-2026
Open, ClassifiedPosted Jun 1, 2026·Initiated Dec 7, 2023
Philips Azurion 7B12/12, Model Numbers: 722067, 722225 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
Reason: 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.
Root cause: Software design
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Type: Interventional Fluoroscopic X-Ray SystemDistribution: US Nationwide distribution.Recall #Z-2288-2026
Open, ClassifiedPosted Jun 1, 2026·Initiated Dec 7, 2023
Philips Azurion 7B20/15, Model Numbers: 722068, 722226 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
Reason: 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.
Root cause: Software design
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Type: Interventional Fluoroscopic X-Ray SystemDistribution: US Nationwide distribution.Recall #Z-2289-2026
Open, ClassifiedPosted Jun 1, 2026·Initiated Dec 7, 2023
Philips Azurion 7M12, Model Numbers: 722078, 722223 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
Reason: 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.
Root cause: Software design
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Type: Interventional Fluoroscopic X-Ray SystemDistribution: US Nationwide distribution.Recall #Z-2290-2026
Open, ClassifiedPosted Jun 1, 2026·Initiated Dec 7, 2023
Philips Azurion 7M20, Model Numbers: 722079, 722224 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
Reason: 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.
Root cause: Software design
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Type: Interventional Fluoroscopic X-Ray SystemDistribution: US Nationwide distribution.Recall #Z-2291-2026
Open, ClassifiedPosted May 29, 2026·Initiated May 6, 2026
Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
Reason: 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 unintended touchscreen behavior on the LVP, including random screen touches and/or lack of screen responsiveness to user input. Under the reported failure condition, unintended touch inputs may register at arbitrary screen locations without user interaction. These inputs occur intermittently and without a predictable pattern.
Root cause: Device Design
Recalling firm: Fresenius Kabi USA, LLCType: Pump, InfusionDistribution: Domestic: CA, CO, FL, GA, ID, IL, MD, MI, MI , MN, MO, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI, WI;Recall #Z-2224-2026
Open, ClassifiedPosted May 29, 2026·Initiated Apr 27, 2026
BDSpinal Tray with BDQuincke Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405609.
Reason: 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.
Root cause: Nonconforming Material/Component
Recalling firm: Becton Dickinson & CompanyType: Anesthesia Conduction KitDistribution: Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OR, PA, PR, SD, TN, TX, UT, VA, WA, WI, WV, WY.Recall #Z-2248-2026
Open, ClassifiedPosted May 29, 2026·Initiated Apr 27, 2026
BDSpinal Tray with BDQuincke Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Numbers: 405621, 405735.
Reason: 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.
Root cause: Nonconforming Material/Component
Recalling firm: Becton Dickinson & CompanyType: Anesthesia Conduction KitDistribution: Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OR, PA, PR, SD, TN, TX, UT, VA, WA, WI, WV, WY.Recall #Z-2249-2026
Open, ClassifiedPosted May 29, 2026·Initiated Apr 27, 2026
BDSpinal Tray with BDQuincke Needle 26 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405632.
Reason: 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.
Root cause: Nonconforming Material/Component
Recalling firm: Becton Dickinson & CompanyType: Anesthesia Conduction KitDistribution: Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OR, PA, PR, SD, TN, TX, UT, VA, WA, WI, WV, WY.Recall #Z-2250-2026
Open, ClassifiedPosted May 29, 2026·Initiated Apr 27, 2026
BDSpinal Tray with BDWhitacre Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405645.
Reason: 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.
Root cause: Nonconforming Material/Component
Recalling firm: Becton Dickinson & CompanyType: Anesthesia Conduction KitDistribution: Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OR, PA, PR, SD, TN, TX, UT, VA, WA, WI, WV, WY.Recall #Z-2251-2026
Open, ClassifiedPosted May 29, 2026·Initiated Apr 27, 2026
BDSpinal Tray with BDWhitacre Needle 24 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Numbers: 400868, 405652.
Reason: 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.
Root cause: Nonconforming Material/Component
Recalling firm: Becton Dickinson & CompanyType: Anesthesia Conduction KitDistribution: Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OR, PA, PR, SD, TN, TX, UT, VA, WA, WI, WV, WY.Recall #Z-2252-2026
Open, ClassifiedPosted May 29, 2026·Initiated Apr 27, 2026
BDSpinal Tray with BDWhitacre Needle 25 G x 3.5 in., BDQuincke Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405741.
Reason: 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.
Root cause: Nonconforming Material/Component
Recalling firm: Becton Dickinson & CompanyType: Anesthesia Conduction KitDistribution: Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OR, PA, PR, SD, TN, TX, UT, VA, WA, WI, WV, WY.Recall #Z-2253-2026