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Yearly recall archive

U.S. Recalls in 2020

Complete FDA and NHTSA recall records dated in 2020, organized for browsing by month, category and recalling company.

4,252recall records

4categories

12months represented

Dec 30, 2020latest record date

Monthly breakdown

2020 recalls by month

Select a month to review the recall records reported during that period.

December 2020315 records · 4 categories November 2020241 records · 4 categories October 2020416 records · 4 categories September 2020371 records · 4 categories August 2020245 records · 4 categories July 2020442 records · 4 categories June 2020342 records · 4 categories May 2020315 records · 4 categories April 2020422 records · 4 categories March 2020368 records · 4 categories February 2020551 records · 4 categories January 2020224 records · 4 categories

2020 recalls — page 24

Records are ordered by the best available source date.

DrugNov 4, 2020

RemedyRepack Metformin Hydrochloride Extended Release 750 mg, 30 count blister cards recall — FDA D-0050-2021

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)

Class IIFDA: TerminatedRemedyRepack Inc.

DrugNov 4, 2020

Jarrow Formulas N-A-C recall — FDA D-0302-2021

Mislabeling of SUS (N-A-C Sustain 600 mg 100 tab) with N-A-C N-Acetyl-L-Cysteine 500 mg, 100 cap.

Class IIFDA: TerminatedJarrow Formulas Inc.

VehicleNov 4, 2020

BMW control arm recall — NHTSA campaign 20V678000

BMW of North America, LLC (BMW) is recalling certain 2020 X5 sDrive40i, xDrive40i, X5 M50i, X5M, X7 xDrive40i, X7 M50i, X6 xDrive40i, X6 M50i and X6M vehicles and 2021 X5 xDrive45e…

control armBMW of North America, LLC

VehicleNov 4, 2020

Toyota Motor Engineering & Manufacturing fuel pump recall — NHTSA campaign 20V682000

Toyota Motor Engineering & Manufacturing (Toyota) is recalling certain 2018-2019 4Runner, 2019-2020 Avalon, 2019 Corolla Hatchback, 2017-2019 Highlander, 2018-2020 Camry, 2020 Corolla,…

fuel pumpToyota Motor Engineering & Manufacturing

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.

About the 2020 recall archive

This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.