PlainRecalls

2020 Recall Year Insight

Federal agencies issued 6,048 product recalls indexed by PlainRecalls in calendar year 2020. That represents about 5.79% of the 104,423 total recalls we track from 1995 through the present, and averages roughly 16.6 recalls per day across the FDA, CPSC, USDA FSIS, and NHTSA combined. Year-level views are the cleanest way to see macro patterns: volume spikes often correlate with new regulatory priorities (e.g., infant-sleep products after 2021, lithium-ion batteries after 2022), supply-chain contamination events, or changes in agency enforcement intensity, while quiet years can reflect either genuine product-safety improvements or reduced agency staffing and reporting lag. With 121 pages at 50 recalls each, browsing this year end-to-end gives a statistically representative sample of what the federal recall pipeline looked like in 2020.

On this page of 50 records, severity classification shows 11 critical, 38 moderate, and 1 lower-severity recalls. The page references 12 distinct recalling firms operating in 1 distinct product categories, with 50 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (50), which matters because each agency's recall authority, hazard framing, and remedy mechanism differ, an FDA food recall, a CPSC consumer-product recall, and a NHTSA vehicle recall are legally distinct instruments even when the underlying hazard language sounds similar. Reviewing the dominant agency for a given year is one of the fastest ways to understand where federal attention was concentrated.

Year-indexed browsing serves three practical purposes: historical research (tracking how a hazard class evolved over time), consumer action (finding whether a product purchased in 2020 was later recalled), and journalistic or regulatory context (understanding what the enforcement landscape looked like in a given period). Every record on this page links to a full detail view with the hazard, remedy, distribution, and agency-assigned recall number, always use that recall number to verify current status directly with the issuing agency before acting on time-sensitive remedies, because agencies amend, terminate, and expand recalls in the months and years after initial publication. Data on this page reflects federal agency public filings; the agency's live record remains authoritative for legal, medical, or safety decisions. Verify with FDA openFDA, CPSC, USDA FSIS, or NHTSA for the system-of-record on any specific recall. PlainRecalls indexes this archive for research and consumer awareness purposes.

FDA Devices Moderate Dec 30, 2020

Infinity ACL Tibial Tip Guide- indicated for use in open and arthroscopic procedures for knee ligament reconstruction. Catalog Number: KTT100

ConMed Corporation

FDA Devices Moderate Dec 30, 2020

Infinity ACL Tibial Elbow Guide-indicated for use in open and arthroscopic procedures for knee ligament reconstruction. Catalog Number: KTE100

ConMed Corporation

FDA Devices Moderate Dec 30, 2020

5 IN (13 cm) Appx 1.5 ml, Bag Spike Adapter, Spiros, REF: 20123-01; 75" (191 cm) Appx 9.1 ml, 20 Drop Admin Set w/ Integrated Clave Drip Chamber, Clave, Spiros, REF: CH3035; 40" (102 cm) Appx 4.5 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Hanger, REF: CH3135; 14" (36 cm) Appx 4.8 ml, Bifuse Add-On Set w/Spiros w/Red Cap, Bag Spike, 3 Clamps (Blue, 2 White), Vented Cap, Drop-In Spiros w/Red Cap, REF: CH3156; 114" Bifuse Primary Set w/2 Spiros, Bag Spike, 2 20 Drop In-line Dri

ICU Medical, Inc.

FDA Devices Moderate Dec 30, 2020

IceFORCE" 2.1 CX 90¿ Cryoablation Needle

Boston Scientific Corporation

FDA Devices Critical Dec 30, 2020

Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-5.0-38-90-RB-SHTL-FLEX-HC, Order Number G31133 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.

Cook Inc.

FDA Devices Moderate Dec 30, 2020

CryoValve SG Pulmonary Human Heart Valve. The valve is cryopreserved in a tissue culture medium containing cryoprotectants within the innermost pouch of a three-pouch packaging system. The packaging system not only withstands ultracold temperatures, but also allows for aseptic introduction of the valve into the operating environment. Supercooling by liquid nitrogen boost is begun prior to crystallization to minimize ice crystal damage to the valve matrix. Finally, the valve is transferred to a

CryoLife, Inc.

FDA Devices Moderate Dec 30, 2020

APEX Compounding System Control Panel Module, REF: 601224, Product Code AX1000 - Product Usage: intended for intravascular administration to a patient.

B Braun Medical, Inc.

FDA Devices Moderate Dec 30, 2020

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administration of fluids.

Baxter Healthcare Corporation

FDA Devices Critical Dec 30, 2020

Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL1-HC, Order Number G49045 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.

Cook Inc.

FDA Devices Moderate Dec 30, 2020

Appx 1.7 ml Bag Spike w/Integrated Clave, 2 Drop-In Spiros, REF: CH3260

ICU Medical, Inc.

FDA Devices Critical Dec 30, 2020

Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL1-HC, Order Number G56227 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.

Cook Inc.

FDA Devices Moderate Dec 30, 2020

IceRod" 1.5 PLUS 90¿ Cryoablation Needle

Boston Scientific Corporation

FDA Devices Moderate Dec 30, 2020

Bactiseal Endoscopic Ventricular Catheter: EVC- Catheter is designed for use in the treatment of hydrocephalus when shunting cerebrospinal fluid (CSF) from the ventricles of the brain. Part Number: 823087

Integra LifeSciences Corp.

FDA Devices Moderate Dec 30, 2020

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) - Product Usage: intended to be used for the controlled administration of fluids.

Baxter Healthcare Corporation

FDA Devices Moderate Dec 30, 2020

76 cm (30") Appx 3.3 ml, Admin Set, 2 Spiros w/Red Cap, 20 Drop In-Line Drip Chamber w/15 Micron Filter, Bag Hanger, REF: 011-CH3261; 44 cm(17 IN) Appx 2.9 ml,PUR YELLOW TRANS SET,ChemoClave,CK VLV,Spiros,PURPLE CAP, REF: 011-CH3568; Oncology Kit, 5 Gang Stopcock w/5 ChemoClave, Spiros w/Red Cap; 10cm Smallbore Bifuse Ext w/2 ChemoClave, Red Ring, BCV; 297cm Ext w/ChemoClave, REF: 011-CH3600; Oncology Kit, 5 Gang Stopcock w/5 ChemoClave, Spiros w/Red Cap; 10cm Smallbore Bifuse Ext, w/2 ChemoClav

ICU Medical, Inc.

FDA Devices Moderate Dec 30, 2020

Baxter Spectrum IQ Infusion System with Dose IQ Safety Software - Product Usage: intended to be used for the controlled administration of fluids.

Baxter Healthcare Corporation

FDA Devices Critical Dec 30, 2020

Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL1-HC, Order Number G56226 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.

Cook Inc.

FDA Devices Moderate Dec 30, 2020

Five IceRod" i-Thaw" Prostate Cryoablation Kit

Boston Scientific Corporation

FDA Devices Critical Dec 30, 2020

Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL0-HC, Order Number G56221 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.

Cook Inc.

FDA Devices Moderate Dec 30, 2020

30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Bag Hanger, REF: 20124-01; Spinning Spiros Closed Male Luer, Red Cap, REF: 20130-01; Spinning Spiros, Closed Male Luer, REF: CH2000S; Spinning Spiros Closed Male Luer, 10 units, REF: CH2000S-10; Spinning Spiros Closed Male Luer, Red Cap, REF: CH2000S-C; Spiros, Closed Male Luer w/Red Cap, 10 Units, RES: CH2000SC-10; Spiros, Closed Male Luer w/Red Cap, 5 Units, REF: CH2000SC-5; Spinning Spiros Closed Male Luer, Pu

ICU Medical, Inc.

FDA Devices Moderate Dec 30, 2020

Haag Streit Surgical Floor stands FS 2-11 (Ref no. 615H511) and FS 2-15 (Ref no. 615H515) in combination with the operating microscopes HS Hi-R NEO 900 (Ref no. 657 820) and HS Hi-R NEO 900A (Ref no. 657 821), with software REF 615 588 versions 2.0 to 3.3 - Product Usage: use in ophthalmology and in other disciplines with vertical direction of view

Haag-Streit USA Inc

FDA Devices Moderate Dec 30, 2020

IceEDGE" 2.4¿ 90p¿ Cryoablation Needle

Boston Scientific Corporation

FDA Devices Moderate Dec 30, 2020

IceSeed" Prostate Cryoablation Kit

Boston Scientific Corporation

FDA Devices Moderate Dec 30, 2020

APEX Compounding System Control Panel Module, REF: 601238, Product Code AX1000 - Product Usage: intended for intravascular administration to a patient.

B Braun Medical, Inc.

FDA Devices Moderate Dec 30, 2020

Three IcePearl" 2.1 CX Prostate Cryoablation Kit

Boston Scientific Corporation

FDA Devices Moderate Dec 30, 2020

Spinning Spiros Closed Male Luer, Red Cap, REF: IB-CH2000SC; 5" (13 cm) Appx 1.5 ml, Add-On Set w/Spiros, REF: IB-CH3034; 5" (13 cm) Appx 1.5 ml, Bag Spike Adapter w/Spiros, Vented Cap, REF: IB-CH3034C

ICU Medical, Inc.

FDA Devices Moderate Dec 30, 2020

31" (78 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros, Bag Hanger, REF: 011-CL3011; 40" (102 cm) Appx 4.9 ml, Admin Set w/ChemoLock, 20 Drop In-Line Drip Chamber, Spiros, Bag Hanger, REF: 011-CL3020; ChemoLock Port w/Spiros, Red Cap, REF: CL-35; 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros, Purple Cap, Hanger, REF: CL3951; 40" (102 cm) Appx 7.7 ml, Admin Set w/ChemoLock w/Red Cap, 20 Drop In-Line Drip Chamber, 0.2 Micron

ICU Medical, Inc.

FDA Devices Moderate Dec 30, 2020

Andorate Disposable Endoscope Valves Set-Contains Air/Water Valve,Suction Valve and Biopsy Valve Product Code: GAR004

GA HEALTH COMPANY LIMITED

FDA Devices Moderate Dec 30, 2020

Andorate Disposable Endoscope Valves Set-Contains Suction, Air/Water, Biopsy Valves and Auxiliary Water Connector Product Code: GAR046

GA HEALTH COMPANY LIMITED

FDA Devices Moderate Dec 30, 2020

IcePearl" 2.1 CX L 90¿ Cryoablation Needle

Boston Scientific Corporation

FDA Devices Critical Dec 30, 2020

Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL1-HC, Order Number G56228 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.

Cook Inc.

FDA Devices Moderate Dec 30, 2020

IceRod" 1.5 MRI Cryoablation Needle¿

Boston Scientific Corporation

FDA Devices Critical Dec 30, 2020

Flexor Check-Flo Introducer, RPN KCFW-7.0-35-55-RB-HFANL0-HC, Order Number G56232 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.

Cook Inc.

FDA Devices Critical Dec 30, 2020

Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-6.0-38-90-RB-SHTL-FLEX-HC, Order Number G31138 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.

Cook Inc.

FDA Devices Moderate Dec 30, 2020

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administration of fluids.

Baxter Healthcare Corporation

FDA Devices Moderate Dec 30, 2020

IceFORCE" 2.1 CX Prostate Cryoablation Kit

Boston Scientific Corporation

FDA Devices Critical Dec 30, 2020

Flexor Check-Flo Introducer, RPN KCFW-7.0-35-55-RB-HFANL1-HC, Order Number G49043 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.

Cook Inc.

FDA Devices Moderate Dec 30, 2020

Stimulan Kit 10cc, Model 600-010 - Product Usage: intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure.

Biocomposites, Ltd.

FDA Devices Critical Dec 30, 2020

Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL1-HC, Order Number G56225 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.

Cook Inc.

FDA Devices Moderate Dec 30, 2020

Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve,Biopsy Valve,Auxiliary Water Jet Connector Diversatek Healthcare 102 E.Keefe Ave. Milwaukee,WI 53212 USA Product Code: 1203-72

GA HEALTH COMPANY LIMITED

FDA Devices Moderate Dec 30, 2020

Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve, Biopsy Valve Manufactured for: Diversatek Healthcare 102 E.Keefe Ave. Milwaukee, WI 53212 USA Product Code: 1203-71

GA HEALTH COMPANY LIMITED

FDA Devices Moderate Dec 30, 2020

IceRod" 1.5 90¿ Cryoablation Needle

Boston Scientific Corporation

FDA Devices Moderate Dec 30, 2020

Three IceFORCE" 2.1 CX Prostate Cryoablation Kit

Boston Scientific Corporation

FDA Devices Moderate Dec 30, 2020

IceSphere" 1.5 90¿ Cryoablation Needle

Boston Scientific Corporation

FDA Devices Low Dec 30, 2020

AMT Male ENFit-to-Stepped Male (Christmas Tree) Adapter, Model Number ETRN102. Box PN TRN102, Box UDI (01)00842071109066(17)230901(10)200918-103, Pouch PN ETRN102, Pouch UDI (01)00842071108007(17)230901(10)200902-075

Applied Medical Technology Inc

FDA Devices Moderate Dec 30, 2020

ScopeValet Guardian Disposable Endoscope Valves Set- Air/Water, Suction, Biopsy Valve, Auxiliary Water Connector Product Code: 345SVVO4

GA HEALTH COMPANY LIMITED

FDA Devices Moderate Dec 30, 2020

STOPCON Disposable Valves Set-Single Use Single Use Valves Olympus R (Air-Water-/Suction-/ Biopsy-Valve) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229

GA HEALTH COMPANY LIMITED

FDA Devices Moderate Dec 30, 2020

STOPCON Suction Valve-Suction Valve for GI-Endoscope DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10232

GA HEALTH COMPANY LIMITED

FDA Devices Moderate Dec 30, 2020

3mL Syringe w/Spinning Spiros, Red Cap, REF: CH2003; 5mL Syringe w/Spinning Spiros, Red Cap, REF: CH2005; 10mL Syringe w/Spinning Spiros, Red Cap, REF: CH2010; 20mL Syringe w/Spinning Spiros, Red Cap, REF: CH2020; 30mL Syringe w/Spinning Spiros, Red Cap, REF: CH2030; 60mL Syringe w/Spinning Spiros, Red Cap, REF: CH2060; 30" (76 cm) Appx 3.3 mL, 20 Drop Admin Set w/Integrated ChemoClave Drip Chamber, Spiros w/Red Cap, Bag Hanger, REF: CH3011; 31" (79 cm) Appx 3.3 ml, Admin Set w/20 Drop Integrat

ICU Medical, Inc.

FDA Devices Critical Dec 30, 2020

Flexor Check-Flo Introducer, RPN KCFW-4.0-35-70-RB-HFANL0-HC, Order Number G56219 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.

Cook Inc.

Nearby Recall Years

Browse recalls from adjacent calendar years to see how federal enforcement volume has shifted over time.

Compare 2020 with 2019 →

Data Sources

  • Source: FDA openFDA Enforcement API - calendar-year recall filings for food, drugs, and devices
  • Source: USDA FSIS Recalls - calendar-year meat, poultry, and processed egg product recall filings
  • Source: CPSC + NHTSA - consumer product and vehicle recall feeds for 2020

Every figure on PlainRecalls is rendered directly from official FDA, CPSC, USDA FSIS and NHTSA recall records; no number is typed in by an editor. Figures cover calendar year 2020 across the FDA, CPSC, USDA FSIS and NHTSA federal recall feeds. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of September 2026.