PlainRecalls

2020 Recalls

4,819 recalls · Page 16 of 97

2020 Recall Year Insight

Federal agencies issued 4,819 product recalls indexed by PlainRecalls in calendar year 2020. That represents about 5.74% of the 83,949 total recalls we track from 1995 through the present, and averages roughly 13.2 recalls per day across the FDA, CPSC, NHTSA, and USDA FSIS 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 97 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 4 critical, 46 moderate, and 0 lower-severity recalls. The page references 14 distinct recalling firms operating in 3 distinct product categories, with 49 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (47), CPSC (2), NHTSA (1), 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, NHTSA, or USDA FSIS for the system-of-record on any specific recall. PlainRecalls indexes this archive for research and consumer awareness purposes.

FDA Devices Moderate Oct 28, 2020

15 cm (6 IN) Appx 1.1 ml, Smallbore Quadfuse Ext Set w/4 NanoClave 3 BCV RLL.1 unit per pouch, 50 pouches per case. UDI:(01)10840619076174(17)25020…

ICU Medical, Inc.

FDA Devices Moderate Oct 28, 2020

Synapse PACS Software Version 5.6.1 - Product Usage: intended for use as a web based application on an off-the shelf PC which meets or exceeds minimu…

Fujifilm Medical Systems U.S.A., Inc.

FDA Devices Moderate Oct 28, 2020

9.5" (24 cm) Appx 0.56 ml, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter, Clamp, Luer Lock; 1 unit per pouch, 50 multivac pouches per case. UDI:(0…

ICU Medical, Inc.

FDA Devices Moderate Oct 28, 2020

60 IN (152cm) APPX 1.1ml, TRIFUSE, Clave STOPCOCK, 2 Clave, FILTER. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709040103(17)250201(30)50(10)…

ICU Medical, Inc.

FDA Devices Moderate Oct 28, 2020

Bien-Air Surgery REF 1600407-001 SN **** FOOTCTRL OSSEODOC - Product Usage: intended to convert electrical energy to mechanically drive handpieces an…

Bien-Air Surgery Sa

FDA Devices Moderate Oct 28, 2020

126 IN (320cm) APPX 23.5ml, 10 Drop Set 3 Clave, Remv Clave Stopcock, 2 Ext.1 unit per pouch, 25 pouches per case. UDI:(01)10887709062365(17)25020…

ICU Medical, Inc.

FDA Devices Moderate Oct 28, 2020

7" (18 cm) Appx 0.31 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave Clear, Clamp, NanoClave T-Connector (Purple Ring), Rotating …

ICU Medical, Inc.

FDA Devices Moderate Oct 28, 2020

Sofia SARS Antigen FIA Package Insert The Sofia SARS Antigen FIA is a lateral flow immunofluorescent sandwich assay that is used with the Sofia a…

Quidel Corporation

FDA Devices Moderate Oct 28, 2020

TWINFIX ULTRA PLLA/HA 5.5 W/3 UB-Absorbable Suture anchor Product Number: 72202603

Smith & Nephew, Inc.

FDA Devices Moderate Oct 28, 2020

7" (18 cm) Appx 0.25 ml, Smallbore Ext Set w/Remv NanoClave, Clamp, Luer Lock. 1 unit per pouch, 50 multivac pouches per case. UDI: (01)1088770906506…

ICU Medical, Inc.

FDA Devices Moderate Oct 28, 2020

TWINFIX AB 5.0 SUTR ANCHR W/2 38 DURAB-Absorbable Suture anchors Product Number: 72200785

Smith & Nephew, Inc.

FDA Devices Moderate Oct 28, 2020

TWINFIX 6.5MM AB PRELOADED SUTURE ANCHOR- Absorbable Suture anchors Product Number: 7210713

Smith & Nephew, Inc.

FDA Devices Moderate Oct 28, 2020

HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BK-- Absorbable Suture anchor Product Number: 72203705

Smith & Nephew, Inc.

FDA Devices Moderate Oct 28, 2020

20 cm (8 IN) APPX 1.0ml, PUR EXT SET, 3-PORT, NanoClave MANIFOLD, BCV, NanoClave.1 unit per pouch, 50 pouches per case. UDI:(01)10840619092754(17)250…

ICU Medical, Inc.

FDA Devices Moderate Oct 28, 2020

149 IN (378cm) APPX 19.1 ml, 15 DROP SET, 3 Clave, REMV 3 GANG 4-WAY Clave STOPCOCK 2 EXT. 1 unit per pouch, 25 pouches per case. UDI:(01)1088770907…

ICU Medical, Inc.

FDA Devices Moderate Oct 28, 2020

40 (102cm) Appx 4.4ml Ext Set, 4-Way Clave Stopcock, Clave, 2 Clamps, Rotating Luer, 1 Ext. 1 unit per pouch, 50 multivac pouches per case. UDI:(0…

ICU Medical, Inc.

FDA Devices Moderate Oct 28, 2020

7 IN(18 cm)APPX 1.2ml. EXT SET, NanoClave T-CONNECTOR, CLAMP, ROTATING LUER. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709075501(17)250101(…

ICU Medical, Inc.

FDA Devices Critical Oct 28, 2020

Langston Dual Lumen Catheter

Vascular Solutions, Inc.

FDA Devices Moderate Oct 28, 2020

EMPOWR Acetabular System *** EMPOWR Acetabular Cup, Cluster Hole, 54G *** Size 54G 54 mm Dia./Cluster Hole Alpha Code G Liner P2 Porous Coated REF …

Encore Medical, LP

FDA Devices Moderate Oct 28, 2020

TWINFIX ULTRA HA 6.5 W/2 UB (BLUE & BLK)- Absorbable Suture anchor Product Number: 72202631

Smith & Nephew, Inc.

FDA Devices Moderate Oct 28, 2020

58 IN (147cm) APPX 8.0 ml, 3 Port NanoClave Manifold NanoClave Stopcock, MicroClave Clear.1 unit per pouch, 25 pouches per case. UDI:(01)108877090…

ICU Medical, Inc.

FDA Devices Moderate Oct 28, 2020

BIORAPTOR 2.9MM SUTURE ANCHOR-Absorbable Suture anchor Product Number: 72201702

Smith & Nephew, Inc.

FDA Devices Moderate Oct 28, 2020

TWINFIX ULTRA PLLA HA 6.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202620

Smith & Nephew, Inc.

FDA Devices Moderate Oct 28, 2020

HEALICOIL RG SA 5.5MM W/2 UB-BL CBR BL-- Absorbable Suture anchor Product Number: 72203706

Smith & Nephew, Inc.

FDA Devices Moderate Oct 28, 2020

NanoClave Connector. 1 unit per pouch, 100 multivac pouches per case. UDI:(01)10840619060906(17)250101(30)100(10)4559476; …

ICU Medical, Inc.

FDA Devices Moderate Oct 28, 2020

12" (30 cm) Appx 0.67 ml, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI…

ICU Medical, Inc.

FDA Devices Moderate Oct 28, 2020

165cm (65 IN)APPX 2.2ml, PUR EXT SET, 3-PORT NanoClave MANIFOLD, BCV, NanoClave. 1 unit per pouch, 50 pouches per case. UDI:(01)10840619062761(17)24…

ICU Medical, Inc.

FDA Devices Moderate Oct 28, 2020

120 IN (305cm)APPX 15.4ml, 10 DROP, 2 Clave STOPCOCK, NanoClave T-Connector, 2 CHECK VALVES. 1 unit per pouch, 50 pouches per case. UDI:(01)1088770…

ICU Medical, Inc.

FDA Devices Moderate Oct 28, 2020

139" (353 cm) 15 Drop Admin Set w/3 MicroClave Clear, 4-Way Stopcock, 3-Port NanoClave Manifold w/Check Valve, Spin Luer, 2 Ext. 1 unit per pouch, 25…

ICU Medical, Inc.

FDA Devices Moderate Oct 28, 2020

9.5" (24 cm) Appx 0.45 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/MicroClave, 2 NanoClave, NanoClave T-Connector, 3 Purple Clamps, Rotating…

ICU Medical, Inc.

FDA Devices Critical Oct 28, 2020

Spectrum IQ Infusion System with Dose IQ Safety Software

Baxter Healthcare Corporation

FDA Devices Moderate Oct 28, 2020

8 IN (20CM) APPX 1.3ml, EXT SET w/3-Port NanoClave Manifold, Check Valve.1 unit per pouch, 50 pouches per case. UDI:(01)10887709085814(17)250101(30…

ICU Medical, Inc.

FDA Devices Moderate Oct 28, 2020

11 IN(28cm)APPX 0.7ml,SMALLBORE, 2 NanoClave, Filter. 1 unit per pouch, 50 pouches per case. UDI: ¿(01)10840619059801(17)250201(30)50(10)4718517; …

ICU Medical, Inc.

FDA Devices Moderate Oct 28, 2020

3-Port NanoClave Manifold w/Check Valve, Rotating Luer. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709087153(17)250101(30)50(10)4556715; (…

ICU Medical, Inc.

FDA Devices Moderate Oct 28, 2020

OSTEORAPTOR 2.9 W/ 1 UB COBRAID BLUE -Absorbable Suture anchor Product Number: 72201994

Smith & Nephew, Inc.

FDA Devices Moderate Oct 28, 2020

Olympus CHF-CB30S Choledoscope Intended Use: The device was designed to be used with an Olympus TV camera system, light source, TV monitor, endo-…

Olympus Corporation of the Americas

FDA Devices Moderate Oct 28, 2020

Yuno II Mobile Operating Table - Product Usage: support and position the patient immediately before, during and after surgical interventions as well …

Maquet Cardiovascular Us Sales, Llc

FDA Devices Moderate Oct 28, 2020

8 IN(20cm) APPX 0.46ml, MicroClave CLEAR, NanoClave T-CONN, FILTER. 1 unit per pouch, 50 pouches per case. UDI: (01)10840619066052(17)250201(30)50(1…

ICU Medical, Inc.

FDA Devices Moderate Oct 28, 2020

9.5 IN (24cm)APPX 1.1ml SMALLBORE TRIFUSE SET,3 MicroClave CLEAR, NanoClave, 3 CHECK VALVES; 1 unit per pouch, 50 pouches per case. UDI:(01)10887709…

ICU Medical, Inc.

FDA Devices Moderate Oct 28, 2020

OSTEORAPTOR 2.3 W 1UB II BLUE-Absorbable Suture anchor Product Number: 72201991

Smith & Nephew, Inc.

FDA Devices Moderate Oct 28, 2020

2 Gang 4-Way NanoClave Stopcock Manifold w/Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709053172(17)241201(30)50(10)4…

ICU Medical, Inc.

FDA Devices Moderate Oct 28, 2020

NanoClave Connector; 1 unit per pouch, 100 multivac pouches per case;UDI (01)10887709051017(17)241201(30)100(10)4549051; (01)10887709051017(17)241101…

ICU Medical, Inc.

FDA Devices Moderate Oct 28, 2020

HEALICOIL RG SA 5.5MM W/3 UB-BL CB BL BK- Absorbable Suture anchor Product Number: 72203707

Smith & Nephew, Inc.

FDA Devices Moderate Oct 28, 2020

135 cm (53") Ext Set w/Remv 5 Gang Stopcock, Baseplate w/7 NanoClave, 4-Way Stopcock, Rotating Luer, 1 Ext..1 unit per pouch, 25 pouches per case. U…

ICU Medical, Inc.

FDA Devices Moderate Oct 28, 2020

Entellus Medical REF SSA-102 SN ******* Shaver System Foot Pedal - Product Usage: The Entellus Medical Shaver System has been designed for shaping bo…

Bien-Air Surgery Sa

FDA Devices Critical Oct 28, 2020

Rashkind Balloon Septostomy Catheter, 5F, Closed end, 50 cm, Pediatric, Single Lumen Product number: 007160 GTIN: 00613994760265 The Rashkind ba…

Medtronic Vascular

FDA Devices Moderate Oct 28, 2020

TWINFIX ULTRA 5.5MM PLLA/HA 2 UBWHT/BL--Absorbable Suture anchor Product Number: 72202602

Smith & Nephew, Inc.

CPSC Moderate Oct 28, 2020

Porter World Trade Recalls Ron Jon Surf Shop Sippy Cup Due to Violations of Federal Lead Content and Phthalates Bans

Yitak Industry Company Limited, of China

CPSC Moderate Oct 28, 2020

Schneider Electric Recalls Surgeloc™ Surge Protection Devices Due to Fire Hazard

Schneider Electric Systems USA, Inc., of Foxboro, Mass.

NHTSA Critical Oct 28, 2020

FREIGHTLINER,MERCEDES-BENZ 2015-2020: STEERING:HYDRAULIC POWER ASSIST:HOSE, PIPING, AND CONNECTIONS

FREIGHTLINER,MERCEDES-BENZ

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: CPSC + NHTSA + USDA FSIS — consumer product, vehicle, and meat/poultry recall feeds for 2020