Open, ClassifiedPosted Jan 29, 2025·Initiated Dec 31, 2024
Medline General Surgery Tray Kits:
1) ARTERIAL LINE INSERTION KIT, Item Number ART1185B;
2) ARTERIAL LINE BUNDLE, Item Number ART255;
3) ARTERIAL LINE TRAY, Item Number ART350;
4) ARTERIAL LINE BUNDLE, Item Number ART355;
5) ARTERIAL LINE BUNDLE, Item Number ART355 ;
6) ARTERIAL LINE INSERTION TRAY, Item Number ART475;
7) ARTERIAL LINE BUNDLE - OR, Item Number ART535A;
8) ARTERIAL LINE TRAY, Item Number ART545A;
9) ARTERIAL LINE INSERTION KIT, Item Number ART775C;
10) ARTERIAL LINE TRAY, Item Number ART840;
11) ARTERIAL LINE KIT, Item Number ART890B
Reason: The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess material on the catheter hub.
Root cause: Process design
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: General Surgery TrayDistribution: US Nationwide.Recall #Z-0991-2025
Open, ClassifiedPosted Jan 29, 2025·Initiated Dec 31, 2024
Medline General Surgery Tray kits:
1) ARTERIAL LINE TRAY, Item Number ART600;
2) A LINE TRAY, Item Number ART690
Reason: The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess material on the catheter hub.
Root cause: Process design
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Tray, SurgicalDistribution: US Nationwide.Recall #Z-0992-2025
Open, ClassifiedPosted Jan 29, 2025·Initiated Dec 20, 2024
AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm
UPN: M00553640
Reason: Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Root cause: Process control
Recalling firm: Boston Scientific CorporationType: Unit, Electrosurgical, Endoscopic (With Or Without Accessories)Distribution: Nationwide including Puerto Rico
Foreign: To be providedRecall #Z-1024-2025 Open, ClassifiedPosted Jan 29, 2025·Initiated Dec 20, 2024
AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm
UPN: M00553650
Reason: Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Root cause: Process control
Recalling firm: Boston Scientific CorporationType: Unit, Electrosurgical, Endoscopic (With Or Without Accessories)Distribution: Nationwide including Puerto Rico
Foreign: To be providedRecall #Z-1025-2025 Open, ClassifiedPosted Jan 29, 2025·Initiated Dec 20, 2024
AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm
UPN: M00553660
Reason: Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Root cause: Process control
Recalling firm: Boston Scientific CorporationType: Unit, Electrosurgical, Endoscopic (With Or Without Accessories)Distribution: Nationwide including Puerto Rico
Foreign: To be providedRecall #Z-1026-2025 Open, ClassifiedPosted Jan 29, 2025·Initiated Dec 20, 2024
AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm
UPN: M00553670
Reason: Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Root cause: Process control
Recalling firm: Boston Scientific CorporationType: Unit, Electrosurgical, Endoscopic (With Or Without Accessories)Distribution: Nationwide including Puerto Rico
Foreign: To be providedRecall #Z-1027-2025 Open, ClassifiedPosted Jan 29, 2025·Initiated Dec 20, 2024
AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm
UPN: M00553680
Reason: Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Root cause: Process control
Recalling firm: Boston Scientific CorporationType: Unit, Electrosurgical, Endoscopic (With Or Without Accessories)Distribution: Nationwide including Puerto Rico
Foreign: To be providedRecall #Z-1028-2025 Open, ClassifiedPosted Jan 29, 2025·Initiated Dec 20, 2024
AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm
UPN: M00553690
Reason: Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Root cause: Process control
Recalling firm: Boston Scientific CorporationType: Unit, Electrosurgical, Endoscopic (With Or Without Accessories)Distribution: Nationwide including Puerto Rico
Foreign: To be providedRecall #Z-1029-2025 Open, ClassifiedPosted Jan 29, 2025·Initiated Dec 20, 2024
AXIOS Stent and Delivery System 10mmx10mm
UPN: M00553740
Reason: Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Root cause: Process control
Recalling firm: Boston Scientific CorporationType: Unit, Electrosurgical, Endoscopic (With Or Without Accessories)Distribution: Nationwide including Puerto Rico
Foreign: To be providedRecall #Z-1030-2025 Open, ClassifiedPosted Jan 29, 2025·Initiated Dec 20, 2024
AXIOS Stent and Delivery System 15mmx10mm
UPN: M00553750
Reason: Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Root cause: Process control
Recalling firm: Boston Scientific CorporationType: Unit, Electrosurgical, Endoscopic (With Or Without Accessories)Distribution: Nationwide including Puerto Rico
Foreign: To be providedRecall #Z-1031-2025 Open, ClassifiedPosted Jan 29, 2025·Initiated Dec 20, 2024
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm
UPN: M00553520
Reason: Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Root cause: Process control
Recalling firm: Boston Scientific CorporationType: Unit, Electrosurgical, Endoscopic (With Or Without Accessories)Distribution: Nationwide including Puerto Rico
Foreign: To be providedRecall #Z-1032-2025 Open, ClassifiedPosted Jan 29, 2025·Initiated Dec 20, 2024
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm
UPN: M00553530
Reason: Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Root cause: Process control
Recalling firm: Boston Scientific CorporationType: Unit, Electrosurgical, Endoscopic (With Or Without Accessories)Distribution: Nationwide including Puerto Rico
Foreign: To be providedRecall #Z-1033-2025 Open, ClassifiedPosted Jan 29, 2025·Initiated Dec 20, 2024
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm
UPN: M00553540
Reason: Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Root cause: Process control
Recalling firm: Boston Scientific CorporationType: Unit, Electrosurgical, Endoscopic (With Or Without Accessories)Distribution: Nationwide including Puerto Rico
Foreign: To be providedRecall #Z-1034-2025 Open, ClassifiedPosted Jan 29, 2025·Initiated Dec 20, 2024
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm
UPN: M00553550
Reason: Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Root cause: Process control
Recalling firm: Boston Scientific CorporationType: Unit, Electrosurgical, Endoscopic (With Or Without Accessories)Distribution: Nationwide including Puerto Rico
Foreign: To be providedRecall #Z-1035-2025 Open, ClassifiedPosted Jan 29, 2025·Initiated Dec 20, 2024
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm
UPN: M00553560
Reason: Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Root cause: Process control
Recalling firm: Boston Scientific CorporationType: Unit, Electrosurgical, Endoscopic (With Or Without Accessories)Distribution: Nationwide including Puerto Rico
Foreign: To be providedRecall #Z-1036-2025 Open, ClassifiedPosted Jan 29, 2025·Initiated Dec 20, 2024
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm
UPN: M00553570
Reason: Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Root cause: Process control
Recalling firm: Boston Scientific CorporationType: Unit, Electrosurgical, Endoscopic (With Or Without Accessories)Distribution: Nationwide including Puerto Rico
Foreign: To be providedRecall #Z-1037-2025 Open, ClassifiedPosted Jan 29, 2025·Initiated Dec 23, 2024
CENTURION Infusion Catheter, 7F, 17cm (DO), Reorder MIC17F7; Infusion Catheter with Antimicrobial Heparin Coating.
Reason: Certain lots Sterile Infusion Catheters which were mislabeled as having a heparin coating were either distributed or manufactured into medical convenience kits and distributed.
Root cause: Process change control
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Introducer, CatheterDistribution: US: FL, KS, ND, PA, WA, WV, IL, WARecall #Z-1048-2025
Open, ClassifiedPosted Jan 29, 2025·Initiated Dec 23, 2024
MEDLINE ARTERIAL LINE PACK, REF DYNJ65208B, medical convenience kit containing Infusion Catheter with Antimicrobial Heparin Coating.
Reason: Certain lots Sterile Infusion Catheters which were mislabeled as having a heparin coating were either distributed or manufactured into medical convenience kits and distributed.
Root cause: Process change control
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: General Surgery TrayDistribution: US: FL, KS, ND, PA, WA, WV, IL, WARecall #Z-1049-2025
Open, ClassifiedPosted Jan 28, 2025·Initiated Jan 6, 2025
NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Purple/C,D - Height 14 mm, Item Number 00-5994-022-14
Reason: It was identified internally that two commingle events occurred where the metal support post within the polyethylene articular surface was assembled incorrectly for three units within the scope.
Root cause: Process change control
Recalling firm: Zimmer, Inc.Type: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerDistribution: Worldwide - US Nationwide distribution in the states of CA, FL, GA, KS, MO, NE, NJ, PA, TN and the countries of CHINA, INDIA, KOREA, MALAYSIA, NETHERLANDS, SINGAPORE, TAIWAN.Recall #Z-1038-2025
Open, ClassifiedPosted Jan 28, 2025·Initiated Jan 6, 2025
NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Yellow/E,F - Height 10 mm, Item Number 00-5994-032-10
Reason: It was identified internally that two commingle events occurred where the metal support post within the polyethylene articular surface was assembled incorrectly for three units within the scope.
Root cause: Process change control
Recalling firm: Zimmer, Inc.Type: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerDistribution: Worldwide - US Nationwide distribution in the states of CA, FL, GA, KS, MO, NE, NJ, PA, TN and the countries of CHINA, INDIA, KOREA, MALAYSIA, NETHERLANDS, SINGAPORE, TAIWAN.Recall #Z-1039-2025