PlainRecalls

2020 Recalls

4,819 recalls · Page 15 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 5 critical, 45 moderate, and 0 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, 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

OSTEORAPTOR 2.9 W 1UB II BLUE--Absorbable Suture anchor Product Number: 72202165

Smith & Nephew, Inc.

FDA Devices Moderate Oct 28, 2020

114" (290 cm) 60 Drop 150ml Burette Set (Clave, Shut Off, Filter) w/4 Clave Remv 3-Port NanoClave Manifold, 2 Check Valves, Rotating Luer, 2 Exts. 1 …

ICU Medical, Inc.

FDA Devices Moderate Oct 28, 2020

26 IN(66cm) APPX 3.9 ml, SET, 3-Port NanoClave Manifold, Check Valve, 2 MicroClave;1 unit per pouch, 50 pouches per case. UDI:(01)10887709086224(17)2…

ICU Medical, Inc.

FDA Devices Moderate Oct 28, 2020

OSTEORAPTOR CRVD 2.3 SA UB COBRD BLUE- Absorbable Suture anchor Product Number: 72203290

Smith & Nephew, Inc.

FDA Devices Moderate Oct 28, 2020

MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Number: 72204984

Smith & Nephew, Inc.

FDA Devices Moderate Oct 28, 2020

DISTALE - 203 cm (80") Bifuse Ext Set w/6 Gang 1o2 Manifold, 8 MicroClave Clear (Green Rings), Back Check Valve, 3-Port NanoClave Manifold, Check Va…

ICU Medical, Inc.

FDA Devices Moderate Oct 28, 2020

ULTRA FAST-FIX AB ASSEMBLY - STRAIGHT-Absorbable Suture anchors Product Number: 72201493

Smith & Nephew, Inc.

FDA Devices Moderate Oct 28, 2020

6" (15 cm) Appx 0.26 ml, Smallbore Ext Set w/Clamp, NanoClave T-Connector, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case; UDI:(01)10…

ICU Medical, Inc.

FDA Devices Moderate Oct 28, 2020

11 IN (28cm) APPX 1.5ml EXT SET NanoClave, 6-Port NanoClave Manifold . 1 unit per pouch, 50 pouches per case. UDI:¿(01)10887709098937(17)241201(30)…

ICU Medical, Inc.

FDA Devices Moderate Oct 28, 2020

10 IN (25cm) APPX 1.1ml, SMALLBORE EXT w/3-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case. UDI: (01)10887709083346(17)25…

ICU Medical, Inc.

FDA Devices Moderate Oct 28, 2020

AltiVate Reverse Small Socket Insert, 44mm Semi Constrained - E-Plus, Part Number: 509-03-044 - Product Usage: Per IFU, DJO Surgical shoulder devices…

Encore Medical, LP

FDA Devices Moderate Oct 28, 2020

6.5" (17 cm) Appx 0.30 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave, NanoClave T-Connector, Purple Clamp, Rotating Luer. 1 uni…

ICU Medical, Inc.

FDA Devices Moderate Oct 28, 2020

OSTEORAPTOR 2.9 W. 2 UB WHITE / BLACK -Absorbable Suture anchor Product Number: 72201996

Smith & Nephew, Inc.

FDA Devices Moderate Oct 28, 2020

Clave Stopcock. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709039916(17)250201(30)50(10)4727496. The ICU Medical Clave Stopcoc…

ICU Medical, Inc.

FDA Devices Moderate Oct 28, 2020

5 IN(13cm) APPX 0.87ml, EXT SET,NanoClave T-CONNECTOR; 1 unit per pouch, 50 pouches per case; UDI: (01)10887709052809(17)250101(30)50(10)4599980.

ICU Medical, Inc.

FDA Devices Moderate Oct 28, 2020

9.5" (24 cm) 0.53 ml, Smallbore Bifuse Ext Set w/NanoClave, 3 Clamps, Rotating Luer;1 unit per pouch, 50 multivac pouches per case. UDI: ¿(01)1088770…

ICU Medical, Inc.

FDA Devices Moderate Oct 28, 2020

226 cm (89 IN) APPX 2.7ml, MicroClave Clear, 1.2v FILTER Nanoclave T-CONN. 1 unit per pouch, 50 pouches per case. UDI: (01)10840619061231(17)250201…

ICU Medical, Inc.

FDA Devices Moderate Oct 28, 2020

58cm (23 IN) APPX 2.1 ml EXT SET Smallbore PUR Yellow w/6-Port Clave, Clave, 2 Clave Stopcock. 1 unit per pouch, 50 pouches per case. UDI: (01)108877…

ICU Medical, Inc.

FDA Devices Moderate Oct 28, 2020

60 IN(152cm) APPX 0.85ml, SMALLBORE, CLAVE STOPCOCK, MicroCLAVE CLEAR. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709040264(17)250201(30)50(…

ICU Medical, Inc.

FDA Devices Moderate Oct 28, 2020

7.5" (19 cm) Appx 0.59 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear (Yellow, Green, Purple Rings), NanoClave T-Connector, 4 Clamps, Rotating Lu…

ICU Medical, Inc.

FDA Devices Moderate Oct 28, 2020

99 IN (251cm) APPX 12.6ml, 20 Drop, 2 Clave, 2 NanoClave 4-Way Stopcocks, Drop-In Ext, Clave; 1 unit per pouch, 25 pouches per case. UDI: (01)1088770…

ICU Medical, Inc.

FDA Devices Moderate Oct 28, 2020

9" (23 cm) Appx 0.63 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, NanoClave, 3 Clamps, 0.2 Micron Filter, Rotating Luer; 1 unit per pouch, 50 m…

ICU Medical, Inc.

FDA Devices Moderate Oct 28, 2020

Bien-Air Surgery REF 1600686-001 SN ******* OSSEOSTAP Footcontrol - Product Usage: an active medical device that convert electrical energy into mecha…

Bien-Air Surgery Sa

FDA Devices Moderate Oct 28, 2020

9 IN(23 cm) Appx 0.89ml, Smallbore Quadfuse, 4 MicroClave Clear, NanoClave, 0.2 Micron Filter;1 unit per pouch, 50 multivac pouches per case. UDI:(01…

ICU Medical, Inc.

FDA Devices Moderate Oct 28, 2020

NanoClave Connector. 1 unit per pouch, 100 multivac pouches per case. UDI:(01)10887709058757(17)250101(30)100(10)4573278; (01)10887709058757(17)250…

ICU Medical, Inc.

FDA Devices Moderate Oct 28, 2020

20 IN(51cm) APPX 2.5ml, Ext w/6-Port NanoClave Manifold, Check Valve.1 unit per pouch, 50 pouches per case. UDI:(01)10887709069203(17)250201(30)50(…

ICU Medical, Inc.

FDA Devices Moderate Oct 28, 2020

78" (198 cm) APPX 1.7ml, EXT SET, MicroClave Clear, 6-PORT NanoClave MANIFOLD, FILTER .1 unit per pouch, 50 pouches per case. UDI:(01)108877091217…

ICU Medical, Inc.

FDA Devices Moderate Oct 28, 2020

NanoClave Stopcock w/NanoClave; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709062112(17)250101(30)50(10)4572842. The ICU Medica…

ICU Medical, Inc.

FDA Devices Moderate Oct 28, 2020

TWINFIX 5.0MM AB SUTURE ANCHOR-Absorbable Suture anchors Product Number: 7210711

Smith & Nephew, Inc.

FDA Devices Moderate Oct 28, 2020

OSTEORAPTOR 2.3 W/ 1 UB COBRAID BLACK-Absorbable Suture anchor Product Number: 72201992

Smith & Nephew, Inc.

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.

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