Open, ClassifiedPosted Jun 3, 2026·Initiated May 6, 2026
LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.
Reason: 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.
Root cause: Software design (manufacturing process)
Recalling firm: Fresenius Kabi USA, LLCType: Pump, InfusionDistribution: US Nationwide distribution in the states of CA, CO, FL, GA, GA, ID, IL, MD, MI, MN, MO, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI.Recall #Z-2223-2026
Open, ClassifiedPosted Jun 3, 2026·Initiated May 6, 2026
Spinal Needle procedure kits:
Material Description (Material Number)
24GA. PENCAN SPINAL BUP. TRAY W/DURAPREP (333867);
25GA. PENCAN SPINAL BUP. TRAY W/DURAPREP (333862);
GOVP24BK 24G PENCAN TRAY W/ BUP & DEXTROS (332607);
P24BK 24G PENCAN TRAY W/BUP & DEXTROSE (333868);
P25BKAY PENCAN SPINAL TRAY (333865);
P27BK PENCAN SPINAL W/BUPIVAC (333871);
P25BK SPINAL TRAY (333851)
Reason: These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huons Co, Ltd., has issued a voluntary recall due to potential quality issues identified during a recent FDA manufacturing facility inspection.
Root cause: Under Investigation by firm
Recalling firm: B Braun Medical IncType: Spinal Anesthesia KitDistribution: US Nationwide distribution.Recall #Z-2276-2026 Open, ClassifiedPosted Jun 3, 2026·Initiated May 6, 2026
Spinocan Spinal Needle procedure kits:
Material Description (Material Number):
Spinocan 26 Ga. x 3-1/2 in. (90 mm), Bupivacaine 0.75% with Dextrose 8.25% Tray (Kit) (333201);
Spinocan 25 Ga. x 3-1/2 in. (90 mm), Bupivacaine 0.75% with Dextrose 8.25% Tray (Kit) (333211);
Spinocan 22 Ga. x 3-1/2 in. (90 mm), Bupivacaine 0.75% with Dextrose 8.25% Tray (Kit) (333231)
Reason: These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huons Co, Ltd., has issued a voluntary recall due to potential quality issues identified during a recent FDA manufacturing facility inspection.
Root cause: Under Investigation by firm
Recalling firm: B Braun Medical IncType: Spinal Anesthesia KitDistribution: US Nationwide distribution.Recall #Z-2277-2026 Open, ClassifiedPosted Jun 3, 2026·Initiated May 6, 2026
Design Options Spinal Tray
Spinal Needle Anesthesia procedure kits:
Material Description (Material Number):
SSK H M C 20061890 (560074),
SSK S C H (560214),
SSK BJC H S (ORIGINAL CUST) (560272),
SSK CA P M C (ORIGINAL CUST) (560327),
SSK T M H (560394),
SSK S O 20070208 (560428),
SSK L G H (ORIGINAL CUST) (560462),
SSK H M H (560465),
SSK BUPIVACAINE TRAY 2068824 (560476),
SSK K F H (560497),
SSK T J U H (560513),
SSK O M C (560521),
SSK CUSTOM SPINAL TRAY (560523),
SSK O R M C (560533),
SSK B S H S 20115122 (560538),
SSK M M (560572),
SSK M S 27GA PENCAN SPINAL TRAY (560580),
SSK S T H & C (560584),
SSK U C (560587),
SSK P25BKG (560603),
SSK P24BKG (560606),
SSK S25BKG (560607),
SSK M C - BUPIVACAINE TRAY (560609),
SSK T M C (560613),
SSK PENCIL POINT SPINAL TRAY (560619),
SSK E O & S H-SPINAL (560621),
SSK BSW SPINAL TRAY (560628),
SSK M C OB DEPT - SPINAL (560645),
SSK B H M (560646),
SSK M G M C (560647),
SSK S M H (560648),
SSK H H S (560660),
O S U M C SPINAL TRAY SSK (560667),
A M C, SSK (560670),
S B H - SPINAL TRAY SSK (560672);
Reason: These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huons Co, Ltd., has issued a voluntary recall due to potential quality issues identified during a recent FDA manufacturing facility inspection.
Root cause: Under Investigation by firm
Recalling firm: B Braun Medical IncType: Spinal Anesthesia KitDistribution: US Nationwide distribution.Recall #Z-2278-2026 Open, ClassifiedPosted Jun 3, 2026·Initiated Apr 24, 2026
Avanta Multi-Patient Administration Tube Sets (AVA 500 MPAT (Part 2 of 2)) used with the Medrad Avanta Injection System;
Catalog number: AVA 500 MPAT (Part 2 of 2);
Affected material numbers: 87629007, 60729458, 86566648;
Reason: Supplier changes resulted in a fit issue with the Contrast Flow Control Valve (CFCV) interface on the Avanta Injector System. Multiple customer reports indicate that the stopcock cannot be reliably engaged with the CFCV snap interface. In instances where engagement is achieved through applied force, the connection is unstable, and the stopcock may disengage before or during contrast injection, leading to procedure interruption.
Root cause: Process control
Recalling firm: Bayer Medical Care, Inc.Type: Injector And Syringe, AngiographicDistribution: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DE, FL, IA, IL, IN, KS, KY, LA, MA, MD, ME, MO, NC, NY, OH, OK, PA, SC, TN, TX, VA, WI and the countries of AE, BA, BE, CA, CH, CN, DE, DK, ES, FR, GB, HK, HR, IL, KW, MT, MX, NL, RO, RU, SE, ZA.Recall #Z-2296-2026
Open, ClassifiedPosted Jun 3, 2026·Initiated Apr 30, 2026
BD Pyxis MedStation 4000
REF: 303
Medication cabinet
Reason: Fingerprint scanner may overheat to a temperature to cause 1st degree burn.
Root cause: Component design/selection
Recalling firm: CareFusion 303, Inc.Type: Cabinet, Table And Tray, AnesthesiaDistribution: US: Nationwide
OUS: AE, AU, BE, BH, BR, CA, CL, ES, GB, IT, KW, MA, MX, NZ, PT, QA, SA, SG, TH, TWRecall #Z-2297-2026
Open, ClassifiedPosted Jun 3, 2026·Initiated Apr 30, 2026
BD Pyxis MedStation ES
REF: 323
Medication cabinet
Reason: Fingerprint scanner may overheat to a temperature to cause 1st degree burn.
Root cause: Component design/selection
Recalling firm: CareFusion 303, Inc.Type: Cabinet, Table And Tray, AnesthesiaDistribution: US: Nationwide
OUS: AE, AU, BE, BH, BR, CA, CL, ES, GB, IT, KW, MA, MX, NZ, PT, QA, SA, SG, TH, TWRecall #Z-2298-2026
Open, ClassifiedPosted Jun 3, 2026·Initiated Apr 30, 2026
BD Pyxis Anesthesia Station ES
REF: 327
Medication cabinet
Reason: Fingerprint scanner may overheat to a temperature to cause 1st degree burn.
Root cause: Component design/selection
Recalling firm: CareFusion 303, Inc.Type: Cabinet, Table And Tray, AnesthesiaDistribution: US: Nationwide
OUS: AE, AU, BE, BH, BR, CA, CL, ES, GB, IT, KW, MA, MX, NZ, PT, QA, SA, SG, TH, TWRecall #Z-2299-2026
Open, ClassifiedPosted Jun 3, 2026·Initiated Apr 30, 2026
BD Pyxis Anesthesia Station 4000
REF: 338
Medication cabinet
Reason: Fingerprint scanner may overheat to a temperature to cause 1st degree burn.
Root cause: Component design/selection
Recalling firm: CareFusion 303, Inc.Type: Cabinet, Table And Tray, AnesthesiaDistribution: US: Nationwide
OUS: AE, AU, BE, BH, BR, CA, CL, ES, GB, IT, KW, MA, MX, NZ, PT, QA, SA, SG, TH, TWRecall #Z-2300-2026
Open, ClassifiedPosted Jun 3, 2026·Initiated Apr 30, 2026
BD Pyxis Mini Main
REF: 349
Medication cabinet
Reason: Fingerprint scanner may overheat to a temperature to cause 1st degree burn.
Root cause: Component design/selection
Recalling firm: CareFusion 303, Inc.Type: Cabinet, Table And Tray, AnesthesiaDistribution: US: Nationwide
OUS: AE, AU, BE, BH, BR, CA, CL, ES, GB, IT, KW, MA, MX, NZ, PT, QA, SA, SG, TH, TWRecall #Z-2301-2026
Open, ClassifiedPosted Jun 3, 2026·Initiated Apr 30, 2026
BD Pyxis MedStation ES Tower
REF: 352
Medication cabinet
Reason: Fingerprint scanner may overheat to a temperature to cause 1st degree burn.
Root cause: Component design/selection
Recalling firm: CareFusion 303, Inc.Type: Cabinet, Table And Tray, AnesthesiaDistribution: US: Nationwide
OUS: AE, AU, BE, BH, BR, CA, CL, ES, GB, IT, KW, MA, MX, NZ, PT, QA, SA, SG, TH, TWRecall #Z-2302-2026
Open, ClassifiedPosted Jun 3, 2026·Initiated Apr 30, 2026
BD Pyxis MedBank Tower
REF: 1145-00
Medication cabinet
Reason: Fingerprint scanner may overheat to a temperature to cause 1st degree burn.
Root cause: Component design/selection
Recalling firm: CareFusion 303, Inc.Type: Cabinet, Table And Tray, AnesthesiaDistribution: US: Nationwide
OUS: AE, AU, BE, BH, BR, CA, CL, ES, GB, IT, KW, MA, MX, NZ, PT, QA, SA, SG, TH, TWRecall #Z-2303-2026
Open, ClassifiedPosted Jun 3, 2026·Initiated Apr 30, 2026
BD Pyxis MedBank Mini
REF: 1147-00
Medication cabinet
Reason: Fingerprint scanner may overheat to a temperature to cause 1st degree burn.
Root cause: Component design/selection
Recalling firm: CareFusion 303, Inc.Type: Cabinet, Table And Tray, AnesthesiaDistribution: US: Nationwide
OUS: AE, AU, BE, BH, BR, CA, CL, ES, GB, IT, KW, MA, MX, NZ, PT, QA, SA, SG, TH, TWRecall #Z-2304-2026
Open, ClassifiedPosted Jun 3, 2026·Initiated May 18, 2026
DeRoyal Industries Inc.
Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm)
Reason: Sterile wound dressing, lacks sterility assurance
Root cause: Under Investigation by firm
Recalling firm: DeRoyal Industries IncType: Dressing, Wound, HydrophilicDistribution: US Nationwide distribution in the states of FL & NC.Recall #Z-2305-2026
Open, ClassifiedPosted Jun 3, 2026·Initiated Apr 21, 2026
MAC 5 A4 Resting ECG Analysis System 855001-001;
MAC 5 A5 Resting ECG Analysis System 8855002-001.
Electrocardiograph
Reason: Software in development inadvertently made available for customer use. Use of this software version can result in clinical information being associated with the incorrect patient. This could impact clinical decision-making.
Root cause: Software Manufacturing/Software Deployment
Recalling firm: GE Medical Systems China Co., Ltd.Type: Transmitters And Receivers, Electrocardiograph, TelephoneDistribution: Worldwide - US Nationwide distribution in the states of Florida and Georgia. The countries of India, Italy, Republic of Korea, and United Kingdom.Recall #Z-2306-2026
Open, ClassifiedPosted Jun 3, 2026·Initiated Apr 27, 2026
Aligned Medical AMS16835 Fluids Kit RX
Reason: Lidocaine Hydrochloride Injection, USP, which was recalled by a supplier for quality issues, was included in custom convenience kits.
Root cause: Nonconforming Material/Component
Recalling firm: Windstone Medical Packaging, Inc.Type: General Surgery TrayDistribution: US Nationwide distribution in the states of IL, VA.Recall #Z-2307-2026
Open, ClassifiedPosted Jun 2, 2026·Initiated Apr 23, 2026
Arvis Hip & Knee 3.0 Instrument Set, REF: IN-28000 containing one of the following components: IN-10500, Impactor V-Block Assembly; IN-10600 , Tracker B; IN-16400, Tracker A; IN-16100, Tracker C; IN-28050, Tracker E
Reason: The V-Block Assembly and Trackers A, B, C and E may exhibit signs of early wear and/or corrosion on the exposed magnet face.
Root cause: Device Design
Recalling firm: Kico Knee Innovation CompanyType: Orthopedic Stereotaxic InstrumentDistribution: Worldwide - US Nationwide distribution in the states of MS, CA, IA, IN, MI, CO, MT, FL, IL, NY, AL, WI, NE, AZ, MN, VT, NH, MD, RI, MA, NJ, PA, KS, WA, ID, OR, TN, VA, PR and the countries of Australia, France, Germany, Italy.Recall #Z-2292-2026
Open, ClassifiedPosted Jun 2, 2026·Initiated Apr 23, 2026
Arvis Hip & Knee 2.0 Instrument Set, REF: IN-21200 containing one of the following components: IN-10500, Impactor V-Block Assembly; IN-10600 , Tracker B; IN-16400, Tracker A; IN-16100, Tracker C
Reason: 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.
Root cause: Device Design
Recalling firm: Kico Knee Innovation CompanyType: Orthopedic Stereotaxic InstrumentDistribution: Worldwide - US Nationwide distribution in the states of MS, CA, IA, IN, MI, CO, MT, FL, IL, NY, AL, WI, NE, AZ, MN, VT, NH, MD, RI, MA, NJ, PA, KS, WA, ID, OR, TN, VA, PR and the countries of Australia, France, Germany, Italy.Recall #Z-2293-2026
Open, ClassifiedPosted Jun 2, 2026·Initiated Apr 20, 2026
Digital Angiography System Trinias:UD150G-40 / D150GC-40;
Digital Angiography System BRANSIST safire:UD150G-40 / D150GC-40;
Digital Angiography System BRANSIST alexa:UD150G-40 / D150GC-40;
Digital Radiography System RADspeed Pro: UD150B-40 / UD150V-40 / UD150L-40 / UD150L-40E/D150BC-40 / D150VC-40 / D150LC-40 / D150LC-40E/D150BC-41 / D150VC-41 / D150LC-41;
Digital Radiography System RADspeed safire: UD150B-40 / D150BC-40;
Radiography System RADspeed fit: N/A (Integrated in the system);
X-RAY R/F SYSTEM SONIALVISION safire17:UD150B-40 / D150BC-40;
X-RAY R/F SYSTEM SONIALVISION safire Plus: UD150B-40 / D150BC-4;0
X-RAY R/F SYSTEM SONIALVISION safire: UD150B-40 / D150BC-40;
X-RAY R/F SYSTEM SONIALVISION VERSA: UD150B-40 / UD150V-40 / UD150L-40/D150BC-40 / D150VC-40 / D150LC-40;
X-RAY R/F SYSTEM FLUOROspeed 300:UD150B-40 / UD150V-40 / UD150L-40/D150BC-40 / D150VC-40 / D150LC-40;
X-RAY R/F SYSTEM SONIALVISION G4:D150BC-40S;
X-RAY R/F SYSTEM FLUOROspeed X1:D150BC-40S
Reason: Electromagnetic contactors within high voltage generator may weld together, resulting in current being supplied to power supply even if power is off.
Root cause: Component design/selection
Recalling firm: Shimadzu Medical SystemsType: Interventional Fluoroscopic X-Ray SystemDistribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Canada, The Bahamas, China, Denmark, Haiti.Recall #Z-2294-2026
Open, ClassifiedPosted Jun 2, 2026·Initiated Dec 10, 2025
Phothera 200, Phototherapy Devices indicated for use to treat diagnosed skin disorders such as, but not limited to, Psoriasis, Vitiligo, and Atopic Dermatitis (Eczema) under the direction of a physician, Model Numbers 210NDT4 and 210NCL4
Reason: Some of the Calibration/Output Certificates had the outputs reversed.
Root cause: Labeling Change Control
Recalling firm: Daavlin Distributing CompanyType: Light, Ultraviolet, DermatologicalDistribution: US Nationwide distribution.Recall #Z-2295-2026