Open, ClassifiedPosted Jan 27, 2026·Initiated Dec 29, 2025
Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R;
Siemens Material Number (SMN): 11574002;
With Software Version VB10D-SP02
Reason: Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be processed.
Root cause: Software design
Recalling firm: Siemens Medical Solutions USA, IncType: Interventional Fluoroscopic X-Ray SystemDistribution: Worldwide - US Nationwide distribution in the states of AK, CA, IL, MN, NY, OR, VA, WI and the countries of Austria, Belgium, Denmark, France, Germany, Greece, Ireland, Italy, Netherlands, Norway, South Africa, Spain, Sweden, Switzerland.Recall #Z-1174-2026
Open, ClassifiedPosted Jan 27, 2026·Initiated Dec 29, 2025
Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T;
Siemens Material Number (SMN): 11574003;
With Software Version VB10D-SP02
Reason: Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be processed.
Root cause: Software design
Recalling firm: Siemens Medical Solutions USA, IncType: Interventional Fluoroscopic X-Ray SystemDistribution: Worldwide - US Nationwide distribution in the states of AK, CA, IL, MN, NY, OR, VA, WI and the countries of Austria, Belgium, Denmark, France, Germany, Greece, Ireland, Italy, Netherlands, Norway, South Africa, Spain, Sweden, Switzerland.Recall #Z-1175-2026
Open, ClassifiedPosted Jan 27, 2026·Initiated Dec 19, 2025
Alphenix INFX-8000C, interventional fluoroscopic x-ray system
Reason: It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional
systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed
Root cause: Process design
Recalling firm: Canon Medical System, USA, INC.Type: Interventional Fluoroscopic X-Ray SystemDistribution: Worldwide distribution - US Nationwide and the country of Dominican Republic.Recall #Z-1176-2026
Open, ClassifiedPosted Jan 27, 2026·Initiated Dec 19, 2025
Alphenix INFX-8000F, interventional fluoroscopic x-ray system
Reason: It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional
systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed
Root cause: Process design
Recalling firm: Canon Medical System, USA, INC.Type: Interventional Fluoroscopic X-Ray SystemDistribution: Worldwide distribution - US Nationwide and the country of Dominican Republic.Recall #Z-1177-2026
Open, ClassifiedPosted Jan 27, 2026·Initiated Dec 19, 2025
Alphenix INFX-8000H, interventional fluoroscopic x-ray system
Reason: It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional
systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed
Root cause: Process design
Recalling firm: Canon Medical System, USA, INC.Type: Interventional Fluoroscopic X-Ray SystemDistribution: Worldwide distribution - US Nationwide and the country of Dominican Republic.Recall #Z-1178-2026
Open, ClassifiedPosted Jan 27, 2026·Initiated Dec 19, 2025
Alphenix INFX-8000V, interventional fluoroscopic x-ray system
Reason: It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional
systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed
Root cause: Process design
Recalling firm: Canon Medical System, USA, INC.Type: Interventional Fluoroscopic X-Ray SystemDistribution: Worldwide distribution - US Nationwide and the country of Dominican Republic.Recall #Z-1179-2026
Open, ClassifiedPosted Jan 27, 2026·Initiated Dec 26, 2025
Bandages and first aid kits: FIRST AID KIT 24/42PC, LUCKY FIRST AID BANDAGES 24CT
Reason: Potential exposure of rodents and rodent activity in the distribution center.
Root cause: Storage
Recalling firm: GOLD STAR DISTRIBUTION INCType: Tape And Bandage, AdhesiveDistribution: US Nationwide distribution in the states of Minnesota.Recall #Z-1180-2026
Open, ClassifiedPosted Jan 27, 2026·Initiated Dec 26, 2025
Condoms, labeled as: TROJAN MAGNUM CONDOMS 6/DSP BLACK, TROJAN LUBRICATED CONDOMS 6/DSP LITE BLUE, TROJAN SPERMICIDE CONDOMS 6/DSP DARK BLUE,
TROJAN ULTRA THIN CONDOMS 6/DSP GREY, TROJAN RIBBED CONDOMS 6/DSP GOLD/BROWN, TROJAN NONLUBRICATED CONDOMS 6/DSP RED, TROJAN ULTRA HER PLEASURE CONDOMS 6/DSP, TROJAN CONDOMS MAGNUM 48 CT DISP, *BOX TROJAN CONDOMS MAGNUM 50CT .
Reason: Potential exposure of rodents and rodent activity in the distribution center.
Root cause: Storage
Recalling firm: GOLD STAR DISTRIBUTION INCType: CondomDistribution: US Nationwide distribution in the states of Minnesota.Recall #Z-1181-2026
Open, ClassifiedPosted Jan 27, 2026·Initiated Dec 26, 2025
Feminine hygiene products, labeled as: KOTEX FREEDOM MAXI NO WINGS 48CT,
ALWAYS THIN LINERS UNSCENTED 12 CT, ALWAYS THIN LINERS SCENTED 12CT, ALWAYS ULT.THIN WINGS REG.12/22CT, ALWAYS ULT.THIN OVER NIGHT WINGS 12/16CT, JULIE MAXI NIGHT W.WINGS 36/10CT, STAY FREE REG. 12/10CT, STAY FREE SUPER 24/6CT, TAMPAX REG. 10CT, TAMPAX SUPER 10CT.
Reason: Potential exposure of rodents and rodent activity in the distribution center.
Root cause: Storage
Recalling firm: GOLD STAR DISTRIBUTION INCType: Tampon, Menstrual, UnscentedDistribution: US Nationwide distribution in the states of Minnesota.Recall #Z-1182-2026
Open, ClassifiedPosted Jan 27, 2026·Initiated Dec 26, 2025
Toothbrushes, labeled as: ORAL B TOOTH BRUSH SHINY CLEAN SOFT 12CT; COLGATE TOOTH BRUSH MED. 12CT; ADULT TOOTHPASTE W BRUSH (WHITENING) 6.4oz/24ct; ADULT TOOTHPASTE W BRUSH (ANTICAV) 6.4oz/24ct.
Reason: Potential exposure of rodents and rodent activity in the distribution center.
Root cause: Storage
Recalling firm: GOLD STAR DISTRIBUTION INCType: Toothbrush, ManualDistribution: US Nationwide distribution in the states of Minnesota.Recall #Z-1183-2026
Open, ClassifiedPosted Jan 27, 2026·Initiated Dec 26, 2025
PREGNANCY TEST 24CT
Reason: Potential exposure of rodents and rodent activity in the distribution center.
Root cause: Storage
Recalling firm: GOLD STAR DISTRIBUTION INCType: Kit, Test, Pregnancy, Hcg, Over The CounterDistribution: US Nationwide distribution in the states of Minnesota.Recall #Z-1184-2026
Open, ClassifiedPosted Jan 27, 2026·Initiated Dec 12, 2025
Conductivity Standard Solution
Catalog/Model Numbers:
10001, 10011, 10021, 10032, 10040, 10040c, and 10041
Conductivity Standard Solutions are a secondary standard solution used for the
calibration of conductivity cells together with conductivity meters
Reason: due to a defect associated with the conductivity values of the solution used to calibrate meters and result in the reporting of incorrect conductivity values for dialysate.
Root cause: Under Investigation by firm
Recalling firm: NIPRO Technical Services, Inc.Type: Solution-Test Standard-Conductivity, DialysisDistribution: U.S. Nationwide distribution in the states of AL, AR, AZ, CA, DE, FL, GA. IL, IN, KS, MI, MO, NC, ND, NJ, NV, NY, OH, OK, OR, PA, SC, TN TX, UT, VA, and WA.Recall #Z-1185-2026
Open, ClassifiedPosted Jan 26, 2026·Initiated Dec 17, 2025
Fixone Hybrid Anchor
Reason: Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Root cause: Nonconforming Material/Component
Recalling firm: Aju Pharm Co., Ltd.Type: Fastener, Fixation, Biodegradable, Soft TissueDistribution: US Nationwide distribution in the states of CA & PR.Recall #Z-1166-2026
Open, ClassifiedPosted Jan 26, 2026·Initiated Dec 17, 2025
Fixone Biocomposite Anchor
Reason: Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Root cause: Nonconforming Material/Component
Recalling firm: Aju Pharm Co., Ltd.Type: Fastener, Fixation, Biodegradable, Soft TissueDistribution: US Nationwide distribution in the states of CA & PR.Recall #Z-1167-2026
Open, ClassifiedPosted Jan 26, 2026·Initiated Dec 17, 2025
Genesis Screw-In Anchor
Reason: Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Root cause: Nonconforming Material/Component
Recalling firm: Aju Pharm Co., Ltd.Type: Fastener, Fixation, Biodegradable, Soft TissueDistribution: US Nationwide distribution in the states of CA & PR.Recall #Z-1168-2026
Open, ClassifiedPosted Jan 26, 2026·Initiated Dec 17, 2025
Genesis Dual Thread Screw-In Anchor
Reason: Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Root cause: Nonconforming Material/Component
Recalling firm: Aju Pharm Co., Ltd.Type: Fastener, Fixation, Biodegradable, Soft TissueDistribution: US Nationwide distribution in the states of CA & PR.Recall #Z-1169-2026
Open, ClassifiedPosted Jan 26, 2026·Initiated Dec 17, 2025
Genesis Knotless Anchor
Reason: Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Root cause: Nonconforming Material/Component
Recalling firm: Aju Pharm Co., Ltd.Type: Fastener, Fixation, Biodegradable, Soft TissueDistribution: US Nationwide distribution in the states of CA & PR.Recall #Z-1170-2026
Open, ClassifiedPosted Jan 26, 2026·Initiated Dec 17, 2025
Genesis Push-In Suture Anchor
Reason: Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Root cause: Nonconforming Material/Component
Recalling firm: Aju Pharm Co., Ltd.Type: Fastener, Fixation, Biodegradable, Soft TissueDistribution: US Nationwide distribution in the states of CA & PR.Recall #Z-1171-2026
Open, ClassifiedPosted Jan 26, 2026·Initiated Dec 17, 2025
AlternatiV+ Max Knotless Anchor
Reason: Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Root cause: Nonconforming Material/Component
Recalling firm: Aju Pharm Co., Ltd.Type: Fastener, Fixation, Biodegradable, Soft TissueDistribution: US Nationwide distribution in the states of CA & PR.Recall #Z-1172-2026
Open, ClassifiedPosted Jan 26, 2026·Initiated Dec 17, 2025
AlternatiV+ Screw-In Anchor
Reason: Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Root cause: Nonconforming Material/Component
Recalling firm: Aju Pharm Co., Ltd.Type: Fastener, Fixation, Biodegradable, Soft TissueDistribution: US Nationwide distribution in the states of CA & PR.Recall #Z-1173-2026