PlainRecalls

2021 Recalls

5,168 recalls · Page 69 of 104

2021 Recall Year Insight

Federal agencies issued 5,168 product recalls indexed by PlainRecalls in calendar year 2021. That represents about 5.08% of the 101,704 total recalls we track from 1995 through the present, and averages roughly 14.2 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 104 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 2021.

On this page of 50 records, severity classification shows 2 critical, 48 moderate, and 0 lower-severity recalls. The page references 10 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 2021 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 May 26, 2021

REF CK000379, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Full Kit, 4F, Single-Lumen, TLS, CE 2797, UDI: (01)10801…

Bard Access Systems Inc.

FDA Devices Moderate May 26, 2021

Medtronic REF: MMT-7020A, Guardian Sensor (3) for the following packaging: GS3 5PK 2L US/ GTIN: 20763000140940 GS3 5PK 2L US/ GTIN: 2076300033…

Medtronic Inc.

FDA Devices Moderate May 26, 2021

REF 7655405, Groshong NXT ClearVue Catheter, Basic Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035279 - Product Usage: is designed for use when ce…

Bard Access Systems Inc.

FDA Devices Moderate May 26, 2021

Medtronic REF: MMT-7020D1 Guardian Sensor (3) for the following packaging: GS3 1PK OUS1/ GTIN: 00643169704084 GS3 1PK 9L OUS1/ GTIN: 0076300024…

Medtronic Inc.

FDA Devices Moderate May 26, 2021

10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), CODE INTVM-DSSKBD

BIOPSYBELL S.R.L.

FDA Devices Moderate May 26, 2021

10G DIRECT WORKING CANNULA BEVEL TIP 15CM, CODE INTVM-DWCB/15

BIOPSYBELL S.R.L.

FDA Devices Moderate May 26, 2021

REF 7655405J, Groshong NXT ClearVue Catheter, Basic Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741200615 - Product Usage: is designed for use when c…

Bard Access Systems Inc.

FDA Devices Moderate May 26, 2021

REF 9617408D, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Maximal Barrier Kit, 4F, Single-Lumen, TLS, UDI: (01)108…

Bard Access Systems Inc.

FDA Devices Moderate May 26, 2021

REF 9617405, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Basic Kit, 4F, Single-Lumen, TLS, UDI: (01)10801741035989…

Bard Access Systems Inc.

FDA Devices Moderate May 26, 2021

Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC015/20, Sterile EO, UDI: (01)00630094430157

Bioseal Corporation

FDA Devices Moderate May 26, 2021

8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTVM-DWCB

BIOPSYBELL S.R.L.

FDA Devices Moderate May 26, 2021

REF 69655405, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Basic Kit, 4F, Single-Lumen, TLS, UDI: (01)1080174114752…

Bard Access Systems Inc.

FDA Devices Moderate May 26, 2021

Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.

Roche Diagnostics Operations, Inc.

FDA Devices Moderate May 26, 2021

Medtronic REF: MMT-7020D3 Guardian Sensor (3) for the following packaging: GS3 1 PK OUS3/ GTIN: 00643169704121 GS3 1PK 9L OUS3/ GTIN: 007630003…

Medtronic Inc.

FDA Devices Moderate May 26, 2021

REF 7617408D, Groshong NXT ClearVue Catheter, Maximal Barrier Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035262 - Product Usage: is designed for …

Bard Access Systems Inc.

FDA Devices Moderate May 26, 2021

10 GAUGE DRILL, CODE INTVM-DRL

BIOPSYBELL S.R.L.

FDA Devices Moderate May 26, 2021

BPB medica RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND TROCAR TIP, 187 mm, 10G, RES RESWTR1112C-US

BIOPSYBELL S.R.L.

FDA Devices Moderate May 26, 2021

8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTV-DWCB

BIOPSYBELL S.R.L.

FDA Devices Moderate May 26, 2021

Medtronic, REF: MMT-7008C, Enlite Glucose Sensor for the following packaging: ENLITE AUS 1 PRESS 5PK/ GTIN: 20763000252032 Product Usage: intende…

Medtronic Inc.

FDA Devices Moderate May 26, 2021

RayStation standalone software radiation therapy treatment planning system. Model Number: 8A, 8B, 9A, 9B, 10A, 10B including some service packs

RAYSEARCH LABORATORIES AB

FDA Devices Moderate May 26, 2021

REF 9617407, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Full Kit, 4F, Single-Lumen, TLS, UDI: (01)10801741035996 …

Bard Access Systems Inc.

FDA Devices Moderate May 26, 2021

Medtronic REF: MMT-7020D4 Guardian Sensor (3) for the following packaging: GS3 1PK 2L CANADA/ GTIN: 00763000179595¿ Product Usage: intended for…

Medtronic Inc.

FDA Devices Moderate May 26, 2021

10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES, CODE INTVM-SCDK

BIOPSYBELL S.R.L.

FDA Devices Critical May 26, 2021

VICI VENOUS STENT System Product Usage: is intended for the treatment of obstructions and occlusions in the venous vasculature.

Boston Scientific Corporation

FDA Devices Moderate May 26, 2021

Alpha Interlock Suspension System Lanyard Body: An external prosthetic device. The Alpha Lanyard includes suction with a one-way air expulsion valve …

WillowWood Global Llc

FDA Devices Moderate May 26, 2021

Medtronic REF: MMT-7020GA, Guardian Sensor (3) for the following packaging: GS3 5PK US GC/ GTIN: 20763000179629 Product Usage: intended for use…

Medtronic Inc.

FDA Devices Moderate May 26, 2021

REF 9655405, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Basic Kit, 4F, Single-Lumen, TLS, UDI: (01)10801741036023…

Bard Access Systems Inc.

FDA Devices Moderate May 26, 2021

Medtronic REF: MMT-7020LB, Guardian Sensor (3) for the following packaging: GS3 1PK US/ GTIN: 763000336998 Product Usage: intended for use with…

Medtronic Inc.

FDA Devices Moderate May 26, 2021

Medtronic REF: MMT-7020C4 Guardian Sensor (3) for the following packaging: GS3 5PK 2L CANADA/ GTIN: 20763000179612 Product Usage: intended for…

Medtronic Inc.

FDA Devices Moderate May 26, 2021

GORE VIBIL Biliary Endoprosthesis: stents, drains and dilators for the biliary ducts. Catalogue numbers: VH1008040, VH1010040, VN1010040, VN0808200 -…

W.L. Gore & Associates, Inc.

FDA Devices Moderate May 26, 2021

REF 7617407, Groshong NXT ClearVue Catheter, Full Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035248 - Product Usage: is designed for use when cen…

Bard Access Systems Inc.

FDA Devices Critical May 26, 2021

VICI RDS VENOUS STENT System Product Usage: is indicated for improving luminal diameter in the iliofemoral veins for the treatment of symptomatic …

Boston Scientific Corporation

FDA Devices Moderate May 26, 2021

RayStation 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, 10A, 10B, RayPlan 1, 2, 7, 8A, 8B, 9A, 10A, 10B including some of the Service Packs. Standalone so…

RAYSEARCH LABORATORIES AB

FDA Devices Moderate May 26, 2021

REF 91660417, Groshong NXT ClearVue Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet Tip, Basic Kit, 4F, Single-Lumen, TPS, CE 2797, UD…

Bard Access Systems Inc.

FDA Devices Moderate May 26, 2021

EASYNJECT, Device for cement infusion in the vertebroplasty procedure, REF KVTGUN-DS

BIOPSYBELL S.R.L.

FDA Devices Moderate May 26, 2021

10G COAXIAL CANNULA WITH TUOHY CONNECTION, CODE INTVM-CC

BIOPSYBELL S.R.L.

FDA Devices Moderate May 26, 2021

10 GAUGE CEMENT DELIVERY CANNULA, CODE INTVM-CDC

BIOPSYBELL S.R.L.

FDA Devices Moderate May 26, 2021

Medtronic REF: MMT-7020LA, Guardian Sensor (3) for the following packaging: GS3 5PK US/ GTIN: 20763000336985 Product Usage: intended for use wit…

Medtronic Inc.

FDA Devices Moderate May 26, 2021

CEMIX - CEMENT MIXING SYSTEM, CODE INTV-MMS

BIOPSYBELL S.R.L.

FDA Devices Moderate May 26, 2021

11G DIRECT WORKING CANNULA DIAMOND TIP MINI, CODE INTVMN-DWCD

BIOPSYBELL S.R.L.

FDA Devices Moderate May 26, 2021

ELUVIA Drug-Eluting Vascular Stent System - Product Usage: indicated for improving luminal diameter in the treatment of symptomatic de-novo or resten…

Boston Scientific Corporation

FDA Devices Moderate May 26, 2021

REF 7617405, Groshong NXT ClearVue Catheter Basic Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741086998 - Product Usage: is designed for use when cen…

Bard Access Systems Inc.

FDA Devices Moderate May 26, 2021

Elecsys Troponin I Immunoassay: Catalog# 05094810160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.

Roche Diagnostics Operations, Inc.

FDA Devices Moderate May 26, 2021

REF CK000516, Groshong NXT ClearVue Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet, Full Kit, 4F, Single-Lumen, TPS, CE 2797, UDI: (0…

Bard Access Systems Inc.

FDA Devices Moderate May 26, 2021

Cobalt HF Quad MRI SureScan Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D) - Product Usage: are multiprogramm…

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

FDA Devices Moderate May 26, 2021

Medtronic REF: MMT-7020D5 Guardian Sensor (3) for the following packaging: GS3 1PK 1L AUS/ GTIN 00763000252069 GS3 1PK 1L AUS/ GTIN 00763000414…

Medtronic Inc.

FDA Devices Moderate May 26, 2021

Medtronic REF: MMT-7020C5 Guardian Sensor (3) for the following packaging: GS3 5PK 1L AUS/ GTIN: 20763000252056 GS3 5PK 1L AUS/ GTIN: 207630004…

Medtronic Inc.

FDA Devices Moderate May 26, 2021

Medtronic REF: MMT-7020C2 Guardian Sensor (3) for the following packaging: GS3 5PK 9L OUS2/ GTIN: 20763000243344 GS3 5PK 9L OUS2/ GTIN: 20763…

Medtronic Inc.

FDA Devices Moderate May 26, 2021

Medtronic, REF: MMT-7008A, Enlite Glucose Sensor for the following packaging: ENLITE PLUS 5PK 23L 1CL /GTIN: 20643169541706, ENLT PLUS 5PK 2L 1CL PR/…

Medtronic Inc.

FDA Devices Moderate May 26, 2021

REF 7812400, Replacement Connector For 4F Groshong NXT clearVue PICC with Extension Leg, Rx Only, Sterile EO, CE 2797, UDI: (01)10801741075268 - Prod…

Bard Access Systems Inc.

Nearby Recall Years

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

Compare 2021 with 2020 →

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 2021

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 2021 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 August 2026.