Open, ClassifiedPosted Aug 10, 2026·Initiated Jul 16, 2026
Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236, with Software Version Numbers: R3.0 and R3.1; Interventional fluoroscopic x-ray system
Reason: Two software related issues affecting Philips Azurion R3.0 and R3.1 systems:
1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment
and
2) Potential loss of geometry movements that may lead to delay of therapy and procedural complications.
Root cause: Software design
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Type: Interventional Fluoroscopic X-Ray SystemDistribution: Worldwide distribution.Recall #Z-2932-2026
Open, ClassifiedPosted Aug 10, 2026·Initiated Jul 13, 2026
OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small
REF: C020130-1
Reason: There is a potential for vaginal speculums to contain a burr on the proximal plastic blade, which may introduce a sharp edge in the contact regions for both the patient and the healthcare provider.
Root cause: Process control
Recalling firm: OBP Medical CorporationType: Speculum, Vaginal, NonmetalDistribution: Worldwide - US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV and the countries of HKG, CAN, NOR, UAE.Recall #Z-2933-2026
Open, ClassifiedPosted Aug 7, 2026·Initiated Apr 30, 2026
BOBBY Balloon Guide Catheter
REF:
BOB-895-CN
BOB-895-EMEA
BOB-895-EMEA-AL
BOB-895-US
MV-BGA01095
For use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems.
Reason: Due to an increase rate of balloon pinhole defects.
Root cause: Under Investigation by firm
Recalling firm: MICROVENTION INC.Type: Catheter, PercutaneousDistribution: Worldwide - U.S. Nationwide distribution in the states of AL, AR, AZ, CA, FL, GA, IA, IL, KS, KY, LA, MI, MN, MO, MT, NC, NH, NM, NY, OH, PA, SD, TN, TX, WA, and WI.
The countries of Europe - Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Lithuania, Netherlands, Norway, Poland, Romania, Slovenia, South Africa, Spain, Sweden, Switzerland, Ukraine, and United Kingdom.
Asia - China, Japan, Jordan, New Zealand, South Korea, and United Arab Emirates.Recall #Z-2912-2026
Open, ClassifiedPosted Aug 7, 2026·Initiated Apr 20, 2026
navify Digital Pathology (on-prem) v2.5, Material Number 10092343001
navify Digital Pathology (Cloud) v2.5. Material Number 09453733001
UDI-DI Code: 761333602095AQ
In the United States, navify Digital Pathology software (previously known as uPath Enterprise Software) is a component of the Roche Digital Pathology Dx device cleared by the US FDA for Whole Slide Imaging purposes.
Roche Digital Pathology Dx is an automated digital slide creation, viewing, and management system.
Reason: Due to complaints received for the Image Management System regarding image/metadata discrepancy with the Viewer window
Root cause: Software design
Recalling firm: Ventana Medical Systems, Inc.Type: Whole Slide Imaging SystemDistribution: Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID IL, IN, KS, KY, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, OK, PA, PR, SC, SD, TN, TX, UT, WI, and WV. The countries of Austria, Belgium, Czech Republic, France, Germany, Ireland, Italy, Netherlands, Romania, Spain, and Switzerland, Argentina, Bosnia & Herzegovina, Brazil, Chile, Colombia, Dominican Republic, Ecuador, Jordan, Mexico, Myanmar, Peru, Turkey, United Kingdom, Australia, Bahrain, Colombia, Hong Kong, Portugal and India.Recall #Z-2913-2026
Open, ClassifiedPosted Aug 7, 2026·Initiated May 22, 2026
GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed.
Reason: 10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010).
Root cause: Process control
Recalling firm: W L Gore & Associates, Inc.Type: Stents, Drains And Dilators For The Biliary DuctsDistribution: U.S. Nationwide distribution in the states of GA and RI.Recall #Z-2914-2026
Open, ClassifiedPosted Aug 7, 2026·Initiated May 22, 2026
GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1006. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed.
Reason: 10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010).
Root cause: Process control
Recalling firm: W L Gore & Associates, Inc.Type: Stents, Drains And Dilators For The Biliary DuctsDistribution: U.S. Nationwide distribution in the states of GA and RI.Recall #Z-2915-2026
Open, ClassifiedPosted Aug 7, 2026·Initiated Jun 4, 2026
Brand Name: Xhibit
Product Name: Xhibit Central Station
Model/Catalog Number: 96102
Software Version: N/A
Product Description: The Spacelabs Healthcare (Spacelabs) Xhibit Central Station, Model 96102. Xhibit offers remote surveillance of patient data for those patients connected to a Spacelabs Healthcare bedside monitors and telemetry systems. The DisplayPort audio/video splitter allows users to extend the audio/video source from the Xhibit to additional external displays or monitors. This extension of audio/video is for viewing only and does not allow interaction with the Xhibit.
Component: The DisplayPort audio/video splitter is a 3rd party external accessory to Xhibit.
Reason: Due to off-the-shelf display port component that has audio/video failures
Root cause: Unknown/Undetermined by firm
Recalling firm: Spacelabs Healthcare, Inc.Type: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Distribution: Worldwide - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, VA, WA, WI, WY and the countries of CANADA, FRANCE, ITALY, MALAYSIA, THAILAND.Recall #Z-2916-2026
Open, ClassifiedPosted Aug 7, 2026·Initiated Jun 26, 2026
Boston Scientific Enhance Transcarotid/Peripheral Access Kit
REF: SR-4F21G7D-MP (Kit-075-03)
Sheath with Dilator , Stiffen Dilator, Nitinol Mandrel Wire w/ Radiopaque Tip [Au}, Needle, Extension Tube with Stopcock
Reason: Black depth markings may detach from the outer sheath of the coaxial dilator introducer component of transcarotid-peripheral access kits.
Root cause: Under Investigation by firm
Recalling firm: Galt Medical CorporationType: Wire, Guide, CatheterDistribution: US Nationwide distribution in the state of MN.Recall #Z-2917-2026
Open, ClassifiedPosted Aug 7, 2026·Initiated Jun 24, 2026
V-Loc 90 Absorbable Wound Closure Device
VLOC 90 0 VL 22 GS-21
VLOCM0336
VLOC 90 0 VL 22 GS-25 VLOCM0436
VLOCM0436
VLOCM0003 V-LOC* 90 4-0 CLR 15CM P12X12
VLOCM0003
VLOCM0013 V-LOC* 90 4-0 CLR 30CM P12X12
VLOCM0013
VLOCM0024 V-LOC* 90 3-0 CLR 45CM P12X12
VLOCM0024
VLOCM0123 V-LOC* 90 4-0 CLR 45CM P14X12
VLOCM0123
VLOCM0315 V-LOC* 90 2-0 VIO 30CM GS21
VLOCM0315
VLOCM0603 V-LOC* 90 4-0 VIO 15CM V20X12
VLOCM0603
VLOCM0604 V-LOC* 90 3-0 VIO 15CM V20X12
VLOCM0604
VLOCM1203 V-LOC* 90 4-0 VIO 15CM CV15
VLOCM1203
VLOCM2115 V-LOC* 90 2-0 VIO 30CM GS22
VLOCM2115
Reason: Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.
Root cause: Equipment maintenance
Recalling firm: Covidien, LPType: Suture, Absorbable, Synthetic, Polyglycolic AcidDistribution: US Nationwide and the countries of Australia, Austria, Belgium, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Guadeloupe, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kosovo, Lebanon, Lithuania, Luxembourg, Mexico, Namibia, Netherlands, North Macedonia, Northern Ireland, Norway,
Oman, Panama, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland,
Taiwan, Thailand, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan.Recall #Z-2918-2026 Open, ClassifiedPosted Aug 7, 2026·Initiated Jun 24, 2026
V-Loc 180 Absorbable Wound Closure Device
BOX BEDSIDE STAPLING IS KING
BOX06614V4
BOX BY PASS FINAL
BOX07405V1
BOX BYPASS CARDON
BOX01056V2
BOX BYPASS DR LAGAE
BOX01482V2
BOX BYPASS KIT DEZEMBER 2025
BOX09222V1
BOX BYPASS KIT NEU BOX 003
BOX08767V1
BOX GASTRIC BYPASS
JAWBYPASS2
BOX GASTRIC BYPASS SIGNIA
BOX02191V11
BOX GASTRICBYPASS KIT V4
BOX06863V4
BOX GB BOX MET LHOOK
PST04884V3
BOX GB ZONDER ENDOHERNIA EGIA
PST04884V6
BOX GBP SIGNIA
BOX08506V2
BOX KIT COLON IHS
KIT00625V1
BOX KIT HERNIA HIATO IHS
KIT01026V1
BOX LAP HERNIE INGUNIAL RIGHT
BOX00051V4
BOX NEW GBP KIT
PST03130V2
BOX ZESTAW DO BARIATRII GB
UCKGB5
BOX ZESTAW DO RYGB
WEJRYGB3
VLOCL0013 V-LOC* 180 4-0 CLR 30CM P12
VLOCL0013
VLOCL0014 V-LOC* 180 3-0 CLR 30CM P12
VLOCL0014
VLOCL0023 V-LOC* 180 4-0 CLR 45CM P12
VLOCL0023
VLOCL0024 V-LOC* 180 3-0 CLR 45CM P12
VLOCL0024
VLOCL0306 V-LOC 180 DEVICE 0 15CM GS-21
VLOCL0306
VLOCL0316 V-LOC* 180 0 GRN 30CM GS21X12
VLOCL0316
VLOCL0345 V-LOC* 180 2-0 GRN 23CM GS21
VLOCL0345
VLOCL0436 V-LOC* 180 0 GRN 60CM GS25X12
VLOCL0436
VLOCL0604 V-LOC* 180 3-0 GRN 15CM V20
VLOCL0604
VLOCL0615 V-LOC* 180 2-0 GRN 30CM V20
VLOCL0615
VLOCL0625 V-LOC* 180 2-0 GRN 45CM V20
VLOCL0625
VLOCL0644 V-LOC* 180 3-0 GRN 23CM V20
VLOCL0644
VLOCL0804 V-LOC 180 3-0 GRN 15CM CV23
VLOCL0804
VLOCL2105 V-LOC* 180 2-0 GRN 15CM GS22
VLOCL2105
VLOCL2145 V-LOC* 180 2-0 GRN 23CM GS22
VLOCL2145
VLOCL2246 VLOC180 0 GRN 9 GS-22
VLOCL2246
Reason: Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.
Root cause: Equipment maintenance
Recalling firm: Covidien, LPType: Suture, Absorbable, Synthetic, Polyglycolic AcidDistribution: US Nationwide and the countries of Australia, Austria, Belgium, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Guadeloupe, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kosovo, Lebanon, Lithuania, Luxembourg, Mexico, Namibia, Netherlands, North Macedonia, Northern Ireland, Norway,
Oman, Panama, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland,
Taiwan, Thailand, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan. Open, ClassifiedPosted Aug 7, 2026·Initiated Jun 24, 2026
Dermalon
88861757-31 DERMALON* 4-0 BLU 75CM C13
88861757-31
88861799-31 DERMALON* 4-0 BLU 75CM C14
88861799-31
Reason: Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.
Root cause: Equipment maintenance
Recalling firm: Covidien, LPType: Suture, Nonabsorbable, Synthetic, PolyamideDistribution: US Nationwide and the countries of Australia, Austria, Belgium, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Guadeloupe, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kosovo, Lebanon, Lithuania, Luxembourg, Mexico, Namibia, Netherlands, North Macedonia, Northern Ireland, Norway,
Oman, Panama, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland,
Taiwan, Thailand, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan.Recall #Z-2920-2026 Open, ClassifiedPosted Aug 7, 2026·Initiated Jun 24, 2026
Surgipro
SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36
SP-623
Reason: Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.
Root cause: Equipment maintenance
Recalling firm: Covidien, LPType: Suture, Nonabsorbable, Synthetic, PolypropyleneDistribution: US Nationwide and the countries of Australia, Austria, Belgium, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Guadeloupe, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kosovo, Lebanon, Lithuania, Luxembourg, Mexico, Namibia, Netherlands, North Macedonia, Northern Ireland, Norway,
Oman, Panama, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland,
Taiwan, Thailand, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan.Recall #Z-2921-2026 Open, ClassifiedPosted Aug 7, 2026·Initiated Jun 24, 2026
Surgipro II
S8698GX SURGIPRO II BL 5/0 18 P-13
S8698GX
Reason: Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.
Root cause: Equipment maintenance
Recalling firm: Covidien, LPType: Suture, Nonabsorbable, Synthetic, PolypropyleneDistribution: US Nationwide and the countries of Australia, Austria, Belgium, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Guadeloupe, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kosovo, Lebanon, Lithuania, Luxembourg, Mexico, Namibia, Netherlands, North Macedonia, Northern Ireland, Norway,
Oman, Panama, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland,
Taiwan, Thailand, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan.Recall #Z-2922-2026 Open, ClassifiedPosted Aug 7, 2026·Initiated Jun 30, 2026
Medline Micro-Kill Bleach Germicidal Bleach Wipes,7" x 8", 150 count, 150 count, Product Number MSC351400AN
Reason: Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life. Reduced bleach concentration may compromise the effectiveness of disinfection, potentially allowing for the survival and persistence of pathogenic microorganisms.
Root cause: Under Investigation by firm
Recalling firm: Medline Industries, LPType: Disinfectant, Medical DevicesDistribution: US Nationwide distribution in the states and territories of Guam, Puerto Rico.Recall #Z-2923-2026
Open, ClassifiedPosted Aug 7, 2026·Initiated Jun 30, 2026
Medline Micro-Kill Bleach Germicidal Bleach Wipes, 6" x 5", 150 count, Product Number MSC351410AN
Reason: Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life. Reduced bleach concentration may compromise the effectiveness of disinfection, potentially allowing for the survival and persistence of pathogenic microorganisms.
Root cause: Under Investigation by firm
Recalling firm: Medline Industries, LPType: Disinfectant, Medical DevicesDistribution: US Nationwide distribution in the states and territories of Guam, Puerto Rico.Recall #Z-2924-2026
Open, ClassifiedPosted Aug 7, 2026·Initiated Jun 30, 2026
Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count, Product Number MSC351450AN
Reason: Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life. Reduced bleach concentration may compromise the effectiveness of disinfection, potentially allowing for the survival and persistence of pathogenic microorganisms.
Root cause: Under Investigation by firm
Recalling firm: Medline Industries, LPType: Disinfectant, Medical DevicesDistribution: US Nationwide distribution in the states and territories of Guam, Puerto Rico.Recall #Z-2925-2026
Open, ClassifiedPosted Aug 7, 2026·Initiated Jun 30, 2026
Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count Bag, Product Number MSC351450BG4
Reason: Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life. Reduced bleach concentration may compromise the effectiveness of disinfection, potentially allowing for the survival and persistence of pathogenic microorganisms.
Root cause: Under Investigation by firm
Recalling firm: Medline Industries, LPType: Disinfectant, Medical DevicesDistribution: US Nationwide distribution in the states and territories of Guam, Puerto Rico.Recall #Z-2926-2026
Open, ClassifiedPosted Aug 7, 2026·Initiated Jul 17, 2026
Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901; invitro diagnostics
Reason: Certain lots of Neisseria meningitidis Gp C 2ml/VL, R30166901, are not performing to IFU criteria not positive to ATCC13102 within 60 Seconds.
Root cause: Under Investigation by firm
Recalling firm: Remel Europe Ltd.Type: Antisera, All Groups, N. MeningitidisDistribution: US Nationwide distribution.Recall #Z-2927-2026
Open, ClassifiedPosted Aug 6, 2026·Initiated Mar 19, 2026
Brand Name: U2 Total Knee System
Product Name: Femoral offset bushing, 0mm and 4mm
Model/Catalog Number: 9323-5310
Software Version: N/A
Product Description: Manual Orthopedic Surgical Instrument
Component: No, N/A
Reason: Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.
Root cause: Device Design
Recalling firm: United Orthopedic Corp.Type: Counter, Sponge, SurgicalDistribution: US Nationwide distribution in the states of Texas and Michigan.Recall #Z-2897-2026
Open, ClassifiedPosted Aug 6, 2026·Initiated Mar 19, 2026
Brand Name: U2 Total Knee System
Product Name: Femoral offset bushing, 2mm and 6mm
Model/Catalog Number: 9323-5312
Software Version: N/A
Product Description: Manual Orthopedic Surgical Instrument
Component: No, N/A
Reason: Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.
Root cause: Device Design
Recalling firm: United Orthopedic Corp.Type: Orthopedic Manual Surgical InstrumentDistribution: US Nationwide distribution in the states of Texas and Michigan.Recall #Z-2898-2026