Class I - Dangerous
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
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Other Medical Devices
đĽ Medical Devices ⢠15,203 recalls
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.
Class I - Dangerous
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Mixing Fleas for SAFE-T-FILL Blood Gas Capillaries, Model 07 9503
ASP Global, LLC.
Class I - Dangerous
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Class I - Dangerous
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
MEDLINE convenience kits labeled as: 1) MAJOR VAGINAL HARPER PACK-LF, REF DYNJ0161768G; 2) ACH MAJOR VAGINAL PACK, REF DYNJ67757B.
Medline Industries
Class I - Dangerous
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ÂżL; Untreated. Model 06 0199 Product Description: A clear, plastic capillary blood collection tube
ASP Global, LLC.
Class I - Dangerous
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Class I - Dangerous
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341;
Becton Dickinson & Company
Class I - Dangerous
BD has confirmed through internal testing that certain device trays failed routine biocompatibility testing.
Class I - Dangerous
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
MEDLINE convenience kits labeled as LOCAL BASIC, REF DYNJ34418M
Medline Industries
Class I - Dangerous
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.
Class I - Dangerous
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
MONARCH Bronchoscope. Model Number: MBR-000211-B
Auris Health
Class I - Dangerous
Potential that product was leak tested with equipment outside of its expected operating range, resulting in bronchoscopes that may not be susceptible to leaks.
Class I - Dangerous
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Class I - Dangerous
Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
Class I - Dangerous
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.
MEDLINE STERILE BASIC EYE PACK 16: 1) REF: DYNJ37743D; 2) REF: DYNJ37743F.
Medline Industries
Class I - Dangerous
Medline has identified specific sterile eye procedure kits with pouch packaging that may exhibit open seals.
SAFE-T-FILL Micro Collection Tube Extender, Model 09 1004
ASP Global, LLC.
Class I - Dangerous
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
MEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF, REF DYNJ0160598C; 2) BIOPSY BREAST PACK, REF DYNJ65361A; 3) BREAST BIOPSY/MASTECTOMY, REF DYNJ908839A.
Medline Industries
Class I - Dangerous
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.