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Stradis Medical, LLC Recalls
93 recalls on record · October 27, 2021 to December 21, 2022 · Medical Devices
Recalls by year
21
22
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
December 21, 2022Medical DevicesFDA
Stradis Medical, LLC dba Stradis Healthcare recalls STRADIS HEALTHCARE, COTTON APPLICATOR 3" Item No.505-010,
Hazard: 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.
December 21, 2022Medical DevicesFDA
Stradis Medical, LLC dba Stradis Healthcare recalls Surgical room, DENTAL SURGICAL PACK, Item No.41236SDSP
Hazard: 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.
December 21, 2022Medical DevicesFDA
Stradis Medical, LLC dba Stradis Healthcare recalls STRADIS HEALTHCARE, Custom Pack, Item No.41213ATCP, dental
Hazard: 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.
December 21, 2022Medical DevicesFDA
Stradis Medical, LLC dba Stradis Healthcare recalls STRADIS HEALTHCARE, DENTAL CUSTOM PACK, Item No.41137TDS,
Hazard: 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.
December 21, 2022Medical DevicesFDA
Stradis Medical, LLC dba Stradis Healthcare recalls Surgical room, Implant Pack, Item No.41111UTI, oral surgery tray
Hazard: 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.
December 21, 2022Medical DevicesFDA
Stradis Medical, LLC dba Stradis Healthcare recalls STRADIS HEALTHCARE, Implants, Item No.41015NSI, dental tray
Hazard: 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.
December 21, 2022Medical DevicesFDA
Stradis Medical, LLC dba Stradis Healthcare recalls Surgical room, SURGICAL PACK, Item No.40996WLS, oral surgery tray
Hazard: 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.
December 21, 2022Medical DevicesFDA
Stradis Medical, LLC dba Stradis Healthcare recalls STRADIS HEALTHCARE, pack Item No.40788SMS, oral surgery tray
Hazard: 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.
December 21, 2022Medical DevicesFDA
Stradis Medical, LLC dba Stradis Healthcare recalls STRADIS HEALTHCARE, Surg Pk, Item No.40714IES, oral surgery tray
Hazard: 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.
December 21, 2022Medical DevicesFDA
Stradis Medical, LLC dba Stradis Healthcare recalls STRADIS HEALTHCARE, Surgical Pk, Item No.40649ECS, dental
Hazard: 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.
December 21, 2022Medical DevicesFDA
Stradis Medical, LLC dba Stradis Healthcare recalls STRADIS HEALTHCARE, Basic Implant Pack, Item No.40561BIP, oral surgery tray
Hazard: 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.
December 21, 2022Medical DevicesFDA
Stradis Medical, LLC dba Stradis Healthcare recalls STRADIS HEALTHCARE, Surg, Item No.40551TMS. oral surgery tray
Hazard: 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.
December 21, 2022Medical DevicesFDA
Stradis Medical, LLC dba Stradis Healthcare recalls STRADIS HEALTHCARE, Surgical Pk, Item No.40510TWS, oral surgery tray
Hazard: 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.
December 21, 2022Medical DevicesFDA
Stradis Medical, LLC dba Stradis Healthcare recalls STRADIS HEALTHCARE, Surg Pack, Item No.40450SMS, dental
Hazard: 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.
December 21, 2022Medical DevicesFDA
Stradis Medical, LLC dba Stradis Healthcare recalls BASIC IMPLANT PACK, Item No. 40310SBI, oral surgery tray
Hazard: 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.
December 21, 2022Medical DevicesFDA
Stradis Medical, LLC dba Stradis Healthcare recalls STRADIS HEALTHCARE, Perio Surgery, Item No. 20177RPSS
Hazard: 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.
December 21, 2022Medical DevicesFDA
Stradis Medical, LLC dba Stradis Healthcare recalls ACE Surgical Supply, 17539 CUSTOM KIT STERILE Item No.003-3880, oral surgery tray
Hazard: 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.
December 21, 2022Medical DevicesFDA
Stradis Medical, LLC dba Stradis Healthcare recalls STRADIS HEALTHCARE, WECKCELL EYE SPEARS, Item Numbers: a) 9430, b) 9431
Hazard: 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.
August 24, 2022Medical DevicesFDA
Stradis Medical, LLC dba Stradis Healthcare recalls NARMD MEDICAL DEPOT Forceps - Kelly Curved 5.5"; Part Number: ZZ-0701
Hazard: The sterile barrier may be compromised.
August 24, 2022Medical DevicesFDA
Stradis Medical, LLC dba Stradis Healthcare recalls NARMD MEDICAL DEPOT Forceps - Kelly Straight 5.5"; Part Number: ZZ-0700
Hazard: The sterile barrier may be compromised.
August 24, 2022Medical DevicesFDA
Stradis Medical, LLC dba Stradis Healthcare recalls NARMD MEDICAL DEPOT Scissors Iris Curved 4.5", Part Number ZZ-0697
Hazard: The sterile barrier may be compromised.
April 13, 2022Medical DevicesFDA
Stradis Medical, LLC dba Stradis Healthcare recalls Coryell Memorial Hosp Total, Joint Pack - Surgical Kit
Hazard: The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.
April 13, 2022Medical DevicesFDA
Stradis Medical, LLC dba Stradis Healthcare recalls Anterior Hip Pack - Surgical Kit
Hazard: The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.
April 13, 2022Medical DevicesFDA
Stradis Medical, LLC dba Stradis Healthcare recalls Total Knee Pack - Surgical Kit
Hazard: The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.
April 13, 2022Medical DevicesFDA
Stradis Medical, LLC dba Stradis Healthcare recalls Lum Lam Custom Pack - Anesthesia Kit
Hazard: The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.
April 13, 2022Medical DevicesFDA
Stradis Medical, LLC dba Stradis Healthcare recalls Surgicare Neuro Pack - Neurological Kit
Hazard: The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.
December 29, 2021Medical DevicesFDA
Stradis Medical, LLC dba Stradis Healthcare recalls Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk
Hazard: 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.
October 27, 2021Medical DevicesFDA
Stradis Medical, LLC dba Stradis Healthcare recalls Standard IUD Insertion Kit
Hazard: Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
October 27, 2021Medical DevicesFDA
Stradis Medical, LLC dba Stradis Healthcare recalls Foundation Kit
Hazard: Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
October 27, 2021Medical DevicesFDA
Stradis Medical, LLC dba Stradis Healthcare recalls Endometrial Biopsy Kit
Hazard: Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.