Medical DeviceOct 28, 2020
Vascular Solutions Langston Dual Lumen Catheter recall — FDA Z-0112-2021
The inner lumen of the Langston catheter may separate from the hub during pressure injection.
Class IFDA: TerminatedVascular Solutions, Inc.
Latest records
Latest recalls — page 946
The newest recall records with useful source details are listed here.
Medical DeviceOct 28, 2020
ICU Medical 107" (272 cm) Appx 9.1 ml, Smallbore Ext Set w/2 Check Valves, NanoClave recall — FDA Z-0198-2021
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.
Class IIFDA: TerminatedICU Medical, Inc.
Medical DeviceOct 28, 2020
ICU Medical 113" (287 cm) Appx 14.7 ml, 10 Drop Admin Set w/MicroClave" Clear, Remv 4-Way recall — FDA Z-0219-2021
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.
Class IIFDA: TerminatedICU Medical, Inc.
Medical DeviceOct 28, 2020
ICU Medical 29 IN (74 cm) APPX 3.9 ml, EXT SET w/ NanoClave 4-Way Stopcock recall — FDA Z-0215-2021
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.
Class IIFDA: TerminatedICU Medical, Inc.
Medical DeviceOct 28, 2020
Smith & Nephew HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product recall — FDA Z-0167-2021
Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
Class IIFDA: OngoingSmith & Nephew, Inc.
Medical DeviceOct 28, 2020
ICU Medical 10 IN (25cm) APPX 1.5ml, Ext w/3-Port NanoClave Manifold, Check Valve. 1 unit recall — FDA Z-0231-2021
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.
Class IIFDA: TerminatedICU Medical, Inc.
Medical DeviceOct 28, 2020
ICU Medical PROXIMALE, 28 cm (11 IN) APPX 1.0ml, EXT Set, 6-PORT NanoClave MANIFOLD recall — FDA Z-0273-2021
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.
Class IIFDA: TerminatedICU Medical, Inc.
Medical DeviceOct 28, 2020
GE Healthcare System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body recall — FDA Z-0128-2021
Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.
Class IIFDA: TerminatedGE Healthcare, LLC
Medical DeviceOct 28, 2020
Vascular Solutions Langston Dual Lumen Catheter recall — FDA Z-0113-2021
The inner lumen of the Langston catheter may separate from the hub during pressure injection.
Class IFDA: TerminatedVascular Solutions, Inc.
Medical DeviceOct 28, 2020
ICU Medical 5.5" (14 cm) Appx 0.50 ml, Smallbore Trifuse Ext Set w/3 MicroClave" Clear recall — FDA Z-0211-2021
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.
Class IIFDA: TerminatedICU Medical, Inc.
Medical DeviceOct 28, 2020
ICU Medical 6.5 IN (17 cm) APPX 0.78 ml, Ext Set w/Clave Clear, Clave 4-Way Stopcock, Spiros recall — FDA Z-0248-2021
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.
Class IIFDA: TerminatedICU Medical, Inc.
Medical DeviceOct 28, 2020
Smith & Nephew TWINFIX ULTRA 6.5MM PLLA/HA 2 UBWHT/BL-Absorbable Suture anchor Product recall — FDA Z-0157-2021
Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
Class IIFDA: OngoingSmith & Nephew, Inc.
Medical DeviceOct 28, 2020
ICU Medical 142 IN (361cm) APPX 18.8 ml, 15 DROP SET 4 MicroClave CLEAR, REMV 3-PORT recall — FDA Z-0227-2021
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.
Class IIFDA: TerminatedICU Medical, Inc.
Medical DeviceOct 28, 2020
Smith & Nephew Genesis (GII) - Product Usage: designed for use in patients in primary and recall — FDA Z-0118-2021
The anterior locking detail does not meet its design specifications.
Class IIFDA: TerminatedSmith & Nephew, Inc.
Medical DeviceOct 28, 2020
Smith & Nephew ULTRA FAST-FIX AB ASSEMBLY - CURVED-Absorbable Suture anchors Product Number recall — FDA Z-0144-2021
Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
Class IIFDA: OngoingSmith & Nephew, Inc.
Medical DeviceOct 28, 2020
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) recall — FDA Z-0120-2021
Baxter is updating the device IFU for safety communication regarding cleaning practices.
Class IFDA: TerminatedBaxter Healthcare Corporation
Medical DeviceOct 28, 2020
ICU Medical 47 IN (119cm) APPX 6.7 ml, EXT, STOPCOCK, 3-Port NanoClave MANIFOLD, MicroClave recall — FDA Z-0234-2021
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.
Class IIFDA: TerminatedICU Medical, Inc.
Medical DeviceOct 28, 2020
Smith & Nephew OSTEORAPTOR CRVD 2.3 SA UB COBRD BLACK- Absorbable Suture anchor Product recall — FDA Z-0166-2021
Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
Class IIFDA: OngoingSmith & Nephew, Inc.
Medical DeviceOct 28, 2020
ICU Medical 60" (152 cm) Appx 1.0 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear recall — FDA Z-0206-2021
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.
Class IIFDA: TerminatedICU Medical, Inc.
Medical DeviceOct 28, 2020
Bien-Air Surgery Sa Stryker Instruments REF 5452-007-000 SN ******* S2 MINI FOOT Pedal recall — FDA Z-0179-2021
The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.
Class IIFDA: OngoingBien-Air Surgery Sa
Medical DeviceOct 28, 2020
ICU Medical 7 IN (18cm) APPX 1.2ml Ext Set w/6-Port NanoClave Manifold, Check Valve. 1 unit recall — FDA Z-0236-2021
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.
Class IIFDA: TerminatedICU Medical, Inc.
Medical DeviceOct 28, 2020
GE Healthcare System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body recall — FDA Z-0129-2021
Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.
Class IIFDA: TerminatedGE Healthcare, LLC
Medical DeviceOct 28, 2020
ICU Medical 98 IN (249cm) APPX 8.4 ml, 60 Drop Set, 2 Clave, REMV 2 Clave STOPCOCKS. 1 unit recall — FDA Z-0257-2021
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.
Class IIFDA: TerminatedICU Medical, Inc.
Medical DeviceOct 28, 2020
Smith & Nephew TWINFIX ULTRA PLLA/HA 6.5 W/3 UB- Absorbable Suture anchor Product Number recall — FDA Z-0158-2021
Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
Class IIFDA: OngoingSmith & Nephew, Inc.
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Recent recall archives
Browse recent months with enough recall history for useful comparison.
October 2026111 records · 4 categoriesSeptember 2026364 records · 4 categoriesAugust 2026302 records · 4 categoriesJuly 2026370 records · 4 categoriesJune 2026376 records · 4 categoriesMay 2026340 records · 4 categoriesApril 2026415 records · 4 categoriesMarch 2026190 records · 4 categoriesFebruary 2026331 records · 4 categoriesJanuary 2026212 records · 4 categoriesDecember 2025389 records · 4 categoriesNovember 2025326 records · 4 categories