PlainRecalls

2020 Recalls

Compiled from official public sources by the editorial team.

5,998 recalls · Page 19 of 120

2020 Recall Year Insight

Federal agencies issued 5,998 product recalls indexed by PlainRecalls in calendar year 2020. That represents about 5.90% of the 101,704 total recalls we track from 1995 through the present, and averages roughly 16.4 recalls per day across the FDA, CPSC, 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 120 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 6 critical, 44 moderate, and 0 lower-severity recalls. The page references 14 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, or NHTSA 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

ULTRA FAST-FIX AB ASSEMBLY-REVERSE CURVE-Absorbable Suture anchor Product Number: 72201495

Smith & Nephew, Inc.

FDA Devices Moderate Oct 28, 2020

TWINFIX ULTRA HA 5.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Number: 72202626

Smith & Nephew, Inc.

FDA Devices Moderate Oct 28, 2020

11" (28 cm) Appx 1.7 ml, Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, NanoClave 4-Way Stopcock, Rotating Luer. 1 unit per pouch, 50 multi…

ICU Medical, Inc.

FDA Devices Moderate Oct 28, 2020

TWINFIX ULTRA PLLA HA 4.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202612

Smith & Nephew, Inc.

FDA Devices Moderate Oct 28, 2020

SOBEL WESTEX Disposable Isolation Gown Made in China RN#71273 SBPP non woven laminate with PE Film - Product Usage: use in patient/healthcare personn…

Sobel Westex

FDA Devices Critical Oct 28, 2020

Langston Dual Lumen Catheter.

Vascular Solutions, Inc.

FDA Devices Moderate Oct 28, 2020

5.5" (14 cm) Appx 0.28 ml, Smallbore Ext Set w/NanoClave, Clamp, Luer Lock. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709077758(17…

ICU Medical, Inc.

FDA Devices Critical Oct 28, 2020

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)

Baxter Healthcare Corporation

FDA Devices Critical Oct 28, 2020

Rashkind Balloon Septostomy Catheter, 6F, Recess Balloon, Closed end, 50 cm, Pediatric, Single Lumen Product number: 008764 GTIN: 00613994760289 …

Medtronic Vascular

FDA Devices Critical Oct 28, 2020

Trevo XP ProVue Retriever, REF (Size): 90182 (4MM x 20MM); 90185 (4MM x 30MM); 90186 (6MM x 25MM). Procedure Pack REF: 80052, 93067, 93068, M0032PK4…

Stryker Neurovascular

FDA Devices Moderate Oct 28, 2020

6 IN (15cm) APPX 0.89ml, Smallbore Set 6-Port NanoClave Manifold.1 unit per pouch, 50 pouches per case. UDI:(01)10887709087719(17)250101(30)50(10)455…

ICU Medical, Inc.

FDA Devices Critical Oct 28, 2020

Rashkind Balloon Septostomy Catheter, 4F, Closed end, 50 cm, Pediatric, Single Lumen Product number: 007161 GTIN: 00613994760272 The Rashkind ba…

Medtronic Vascular

FDA Devices Moderate Oct 28, 2020

6 IN (15 cm) Ext Set, MicroClave Clear, T-Connector, RLL, Approx PV: 0.86 mL.1 unit per pouch, 50 pouches per case. UDI:(01)10887709079877(17)25010…

ICU Medical, Inc.

FDA Devices Moderate Oct 28, 2020

8.5" (22 cm) Appx 0.57 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

System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high sign…

GE Healthcare, LLC

FDA Devices Moderate Oct 28, 2020

HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL-- Absorbable Suture anchor Product Number: 72203704

Smith & Nephew, Inc.

FDA Devices Moderate Oct 28, 2020

Siemens Dimension Vista Akaline Phosphatase (ALPI) Flex reagent cartridge - In vitro diagnostic test for the quantitative measurement of alkaline ph…

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Oct 28, 2020

VICRYL MONOFILAMENT VIOLET 4IN (10CM) USP 10-0 (M0.2) SINGLE-ARMED CS140-6 - Product Usage: Intended for ophthalmic soft tissue approximation/ligatio…

Ethicon, Inc.

FDA Devices Moderate Oct 28, 2020

10" (25 cm) Appx 2.8 ml, Trifuse Ext Set w/3 MicroClave¿ Clear, Tri-Connector, NanoClave¿ T-Connector, 4 Clamps (Red, White, Blue), Rotating Luer;1 u…

ICU Medical, Inc.

FDA Devices Moderate Oct 28, 2020

22" (56 cm) Appx 2.5 ml, Ext Set w/4-Way Clave Stopcock, Clamp, Luer Lock. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709051967(17)…

ICU Medical, Inc.

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.

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 - consumer product and vehicle recall feeds for 2020

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Figures cover calendar year 2020 across the FDA, CPSC 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 July 2026.