Stradis Medical recalls

Stradis Medical appears in 93 official U.S. recall notices indexed by RecallRadar.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

• STRADIS HEALTHCARE, Basic Implant Pack, Item No.40561BIP, oral surgery tray
  FDA Device · Class II · 2022-12-21 · Stradis Medical
  Reason: Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
• HENRY SCHEIN, Basin Pack, Item No.570-1692
  FDA Device · Class II · 2022-12-21 · Stradis Medical
  Reason: Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
• Surgical room, DENTAL SURGICAL PACK, Item No.41236SDSP
  FDA Device · Class II · 2022-12-21 · Stradis Medical
  Reason: Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
• HENRY SCHEIN, RHINO PACK, Item No.570-3070
  FDA Device · Class II · 2022-12-21 · Stradis Medical
  Reason: Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
• STRADIS HEALTHCARE, TIP, SURGE-O-VAC .125" GREEN, Item No.SS077225
  FDA Device · Class II · 2022-12-21 · Stradis Medical
  Reason: Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
• STRADIS HEALTHCARE, Varicosity Basic Pack, Item No.682-947
  FDA Device · Class II · 2022-12-21 · Stradis Medical
  Reason: Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
• HENRY SCHEIN, OMFS, Item No.570-2779
  FDA Device · Class II · 2022-12-21 · Stradis Medical
  Reason: Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
• Surgical room, Implant Pack, Item No.41111UTI, oral surgery tray
  FDA Device · Class II · 2022-12-21 · Stradis Medical
  Reason: Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
• STRADIS HEALTHCARE, Introducer Kit Micro, Item No.525-038, cardiovascular
  FDA Device · Class II · 2022-12-21 · Stradis Medical
  Reason: Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
• STRADIS HEALTHCARE, VENOUS ACCESS PACK, Item No.682-1993R1
  FDA Device · Class II · 2022-12-21 · Stradis Medical
  Reason: Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
• www.StradisHealthcare.com, Endovenous Pack, Item No.682-494
  FDA Device · Class II · 2022-12-21 · Stradis Medical
  Reason: Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
• STRADIS HEALTHCARE, Vein RF Pack, Item No.682-1942NL1
  FDA Device · Class II · 2022-12-21 · Stradis Medical
  Reason: Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
• STRADIS HEALTHCARE, Vein & Laser, Item No.682-334R1
  FDA Device · Class II · 2022-12-21 · Stradis Medical
  Reason: Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
• ACE Surgical Supply, 17539 CUSTOM KIT STERILE Item No.003-3880, oral surgery tray
  FDA Device · Class II · 2022-12-21 · Stradis Medical
  Reason: Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
• HENRY SCHEIN, SURGICAL PAIN TRAY, Item No.570-1482
  FDA Device · Class II · 2022-12-21 · Stradis Medical
  Reason: Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
• HENRY SCHEIN, ILR Insertion Tray, Item No.570-3131
  FDA Device · Class II · 2022-12-21 · Stradis Medical
  Reason: Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
• STRADIS HEALTHCARE, Implants, Item No.41015NSI, dental tray
  FDA Device · Class II · 2022-12-21 · Stradis Medical
  Reason: Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
• HENRY SCHEIN, Blue Tail Custom Pack, Item No.570-3091
  FDA Device · Class II · 2022-12-21 · Stradis Medical
  Reason: Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
• STRADIS HEALTHCARE, DENTAL CUSTOM PACK, Item No.41137TDS
  FDA Device · Class II · 2022-12-21 · Stradis Medical
  Reason: Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
• STRADIS HEALTHCARE, Surgery PK, Item No.682-1728
  FDA Device · Class II · 2022-12-21 · Stradis Medical
  Reason: Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
• STRADIS HEALTHCARE, Lipo, Item No.681-254
  FDA Device · Class II · 2022-12-21 · Stradis Medical
  Reason: Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
• STRADIS HEALTHCARE, Perio Surgery, Item No. 20177RPSS
  FDA Device · Class II · 2022-12-21 · Stradis Medical
  Reason: Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
• HENRY SCHEIN, ENT PACK, Item No.570-2718
  FDA Device · Class II · 2022-12-21 · Stradis Medical
  Reason: Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
• HENRY SCHEIN, VEIN TRAY, Item No.570-2738
  FDA Device · Class II · 2022-12-21 · Stradis Medical
  Reason: Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
• STRADIS HEALTHCARE, CURVED TIP SYRINGE, Item No.60060GCTS
  FDA Device · Class II · 2022-12-21 · Stradis Medical
  Reason: Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
• STRADIS HEALTHCARE, Ablation Pack, Item No.682-130
  FDA Device · Class II · 2022-12-21 · Stradis Medical
  Reason: Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
• HENRY SCHEIN, Breast Augmentation tray, Item No.570-0611
  FDA Device · Class II · 2022-12-21 · Stradis Medical
  Reason: Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
• HENRY SCHEIN, Vas Reversal Pack, Item No.888-2549
  FDA Device · Class II · 2022-12-21 · Stradis Medical
  Reason: Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
• NARMD MEDICAL DEPOT Scissors Iris Curved 4.5", Part Number ZZ-0697
  FDA Device · Class II · 2022-08-24 · Stradis Medical
  Reason: The sterile barrier may be compromised.
• NARMD MEDICAL DEPOT Forceps - Kelly Straight 5.5"
  FDA Device · Class II · 2022-08-24 · Stradis Medical
  Reason: The sterile barrier may be compromised.
• NARMD MEDICAL DEPOT Forceps - Kelly Curved 5.5"
  FDA Device · Class II · 2022-08-24 · Stradis Medical
  Reason: The sterile barrier may be compromised.
• Lum Lam Custom Pack - Anesthesia Kit
  FDA Device · Class II · 2022-04-13 · Stradis Medical
  Reason: The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.
• Anterior Hip Pack - Surgical Kit
  FDA Device · Class II · 2022-04-13 · Stradis Medical
  Reason: The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.
• Coryell Memorial Hosp Total, Joint Pack - Surgical Kit
  FDA Device · Class II · 2022-04-13 · Stradis Medical
  Reason: The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.
• Total Knee Pack - Surgical Kit
  FDA Device · Class II · 2022-04-13 · Stradis Medical
  Reason: The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.
• Surgicare Neuro Pack - Neurological Kit
  FDA Device · Class II · 2022-04-13 · Stradis Medical
  Reason: The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.
• Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk
  FDA Device · Class II · 2021-12-29 · Stradis Medical
  Reason: This recall has been initiated to address bulk packed, non-sterile Intravascular Administration Sets that were erroneously distributed to fill orders for the sterile version of the same Intravascular Administration Set.
• Tenaculum, Plastic
  FDA Device · Class II · 2021-10-27 · Stradis Medical
  Reason: Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
• IUD Insertion Kit
  FDA Device · Class II · 2021-10-27 · Stradis Medical
  Reason: Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
• Foundation Kit
  FDA Device · Class II · 2021-10-27 · Stradis Medical
  Reason: Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
• IUD Insertion Pack
  FDA Device · Class II · 2021-10-27 · Stradis Medical
  Reason: Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
• Endometrial Biopsy Kit
  FDA Device · Class II · 2021-10-27 · Stradis Medical
  Reason: Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
• Standard IUD Insertion Kit
  FDA Device · Class II · 2021-10-27 · Stradis Medical
  Reason: Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.