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Monthly recall archive

U.S. Recalls — October 2020

Complete FDA and NHTSA recall records dated in October 2020.

416recall records

4categories

Oct 7, 2020first record date

Oct 29, 2020latest record date

Recall records from October 2020

These records include useful source details for the selected month.

2020 archive →

VehicleOct 29, 2020

General Motors automatic transmission recall — NHTSA campaign 20V668000

General Motors LLC (GM) is recalling certain 2018-2019 Chevrolet Cruze and Buick LaCrosse, 2018-2020 Chevrolet Equinox, Chevrolet Traverse and GMC Terrain, 2018 Chevrolet Malibu, 2019-2020…

automatic transmissionGeneral Motors LLC

Medical DeviceOct 28, 2020

ICU Medical 128" (325 cm) Appx 16.6 ml, 15 Drop Primary Set w/2 MicroClave, Remv 2 Gang recall — FDA Z-0244-2021

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 10 IN (25cm) APPX 1.5ml EXT w/6-Port NanoClave Manifold, Check Valve. 1 unit per recall — FDA Z-0235-2021

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 7" (18 cm) Appx 0.32 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/Remv recall — FDA Z-0201-2021

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 112 IN(284cm) APPX 14.6ml, 15 Drop Set 3 MicroClave, 3-Port NanoClave Manifold recall — FDA Z-0226-2021

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 Tomographic Imager Combining Emission Computed Tomography With Nuclear recall — FDA Z-0131-2021

Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.

Class IIFDA: TerminatedGE Healthcare, LLC

Medical DeviceOct 28, 2020

ICU Medical 11 IN(28cm)APPX 0.97ml,SMALLBORE SET,NanoClave,6-PORT NanoClave MANIFOLD,BCV.1 recall — FDA Z-0240-2021

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 5.5" (14 cm) Appx 0.39 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear recall — FDA Z-0259-2021

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 54 IN (137 cm) APPX 7.2 ml EXT SET w NanoClave 4-Way Stopcock recall — FDA Z-0216-2021

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 112 IN (284cm) APPX 14.8ml, 15 Drop Set 3 MicroClave, Remv 3-Port NanoClave recall — FDA Z-0228-2021

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

Siemens Healthcare Diagnostics Atellica IM HER-2/neu (H2n) assay, 50 Test Kit, Catalog No recall — FDA Z-0115-2021

Siemens confirmed that the Upper Limit of Normal (ULN) as claimed in the Instructions for Use (IFU) was no longer achieved. This can potentially result in false positive or false negative…

Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.

Medical DeviceOct 28, 2020

ICU Medical 148 IN (376cm) APPX 18.8 ml, 15 DROP SET, 2 CLAVE, Remv 3 Gang Clave Stopcock.1 recall — FDA Z-0255-2021

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 124" (315 cm) 60 Drop 150 mL Burette Set (w/Clave, Shut-Off), Remv 2 Gang Clave recall — FDA Z-0260-2021

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 HA 4.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product recall — FDA Z-0162-2021

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 SURPLUG Nano Connector.1 unit per pouch, 100 multivac pouches per case recall — FDA Z-0280-2021

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 123 IN (312cm) APPX 16.1 ml, 10 DROP SET w/3 MicroClave, 3-Port NanoClave recall — FDA Z-0222-2021

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

Boston Scientific Opticross 35 15 MHz Peripheral Imaging Catheter 8F (2.74 mm) X 105 cm recall — FDA Z-0181-2021

Opticross 35 Peripheral Imaging Catheter is being recalled because the incremental telescoping length markings near the proximal end of the catheter shaft can flake off when the device is…

Class IIFDA: TerminatedBoston Scientific Corporation

Medical DeviceOct 28, 2020

ICU Medical 78 IN (198cm) APPX 10.0 ml, 20 Drop Set 3-Port NanoClave Manifold, BCV recall — FDA Z-0229-2021

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 MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product recall — FDA Z-0174-2021

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 8" (20 cm) Appx 0.33 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave Clamp recall — FDA Z-0276-2021

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 5.5MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product recall — FDA Z-0173-2021

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

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.

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.

How to use this monthly recall archive

Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.