PlainRecalls

2021 Recall Year Insight

Federal agencies issued 5,231 product recalls indexed by PlainRecalls in calendar year 2021. That represents about 5.01% of the 104,423 total recalls we track from 1995 through the present, and averages roughly 14.3 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 105 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 1 critical, 49 moderate, and 0 lower-severity recalls. The page references 11 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, 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 Feb 17, 2021

INJECTOR FORCEMAX SIF 270CM 23G 4MM, model no. NM-400Y-0423 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

KD-620LR ELECTROSURGICAL SNARE, model no. KD-620LR - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract.

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

MAJ-247 SINGLE USE 30MM REPLACEMENT BASKET, model no. MAJ-247 - Product Usage: REPLACEMENT BASKET for BML-3Q Mechanical Lithotripter.

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products.

DePuy Orthopaedics, Inc.

FDA Devices Moderate Feb 17, 2021

INJECTOR FORCEMAX UP 2.8MMCH 25G 5MM, model no. NM-400L-0525 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

SD-240U-15 ELECTROSURGICAL SNARE, model no. SD-240U-15 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

K-203 GUIDE SHEATH KIT 2.6MM, model no. K-203 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

PBD-203-0703 BILIARY STENT, model no. PBD-203-0703 - Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage.

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

Lab Coats SMS 2X-Large White, SKU 2304LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material where minimal fluid settings are expected.

Cardinal Health 200, LLC

FDA Devices Moderate Feb 17, 2021

Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19, 1/19 GA Flexcore Biopsy Needle, 7F Introducer Sheath W/Curved Metal Stiffener, Tissue Removal Swabs, 5F Straight Catheter, 5F Curved Catheter, Sterile EO,

Argon Medical Devices, Inc

FDA Devices Moderate Feb 17, 2021

NEEDLEMASTER 5MMx 25G UPPER, model no. NM-610L-0525 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

K-201 GUIDE SHEATH Kit 2.0MM, model no. K-201 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

Covidien ChemoPlus Chemo Spill Kit, Nonsterile, SKU DP5108K

Cardinal Health 200, LLC

FDA Devices Moderate Feb 17, 2021

INJECTOR FORCEMAX UP 2.8MMCH 23G 4MM, model no. NM-400L-0423 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

INJECTOR FORCEMAX LOWER 25G 5MM, model no. NM-400U-0525 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

B5-2C BALLOON CATHETER 11MM DIA 2.0; Model No. B5-2C - Product Usage: Used with endoscopes to inject contrast medium or other medical fluid into the bile duct, pancreatic duct, and respiratory organs.

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18N, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, Sterile EO,

Argon Medical Devices, Inc

FDA Devices Moderate Feb 17, 2021

K-201 GUIDE SHEATH KIT 2.0MM, model no. K-201 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

INJECTOR FORCEMAX LOWER 25G 5MM, model no. NM-400U-0525 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

KD-655L ELECTROSURGICAL SNARE, model no. KD-655L - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract.

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

Infinity Acute Care System (IACS) Monitoring Solution: The IACS is intended for multi-parameter, physiologic patient monitoring of adult, pediatric and neonatal patients in environments where patient care is provided by trained healthcare professionals.

Draegar Medical Systems, Inc.

FDA Devices Moderate Feb 17, 2021

NA-401D-1521 ASPIRATION NEEDLE, model no. NA-401D-1521 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

PBD-203-0707 BILIARY STENT, model no. PBD-203-0707 -Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage.

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

EliA dsDNA Well - Product Usage: intended for the In-Vitro quantitative measurement of IgG antibodies directed to dsDNA in human serum and plasma as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE). Material Number: 14-5500-01

Phadia US Inc

FDA Devices Critical Feb 17, 2021

EMBLEM MRI S-ICD Model A219

Boston Scientific Corporation

FDA Devices Moderate Feb 17, 2021

9180 Electrolyte Analyzer - Product Usage: intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and lithium in the whole blood, serum or plasma, urine, dialysate solutions, or QC materials. catalog number 03157334001 . in vitro diagnostic use.

Roche Diagnostics Operations, Inc.

FDA Devices Moderate Feb 17, 2021

INJECTOR FORCEMAX UP 2.8MMCH 25G 4MM, model no. NM-400L-0425 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

NEEDLEMASTER 3MMx 26G LOWER, model no. NM-610U-0326 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

154 cm (61 IN) APPX 1.5ml, PUR YELLOW EXT, 1.2 MICRON FILTER - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).

ICU Medical, Inc.

FDA Devices Moderate Feb 17, 2021

INJECTOR FORCEMAX LOWER 25G 6MM, model no. NM-400U-0625 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19N, 1/19 GA Flexcore Biopsy Needle, 1.7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, Sterile EO,

Argon Medical Devices, Inc

FDA Devices Moderate Feb 17, 2021

PBD-203-0710 BILIARY STENT, model no. PBD-203-0710 -Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage.

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

SD-240U-25 ELECTROSURGICAL SNARE, model no. SD-240U-25 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

NA-200H-8022 22G EZSHOT ASPIRATION NEEDLE, model no. NA-200H-8022 - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and extramural lesions of the gastrointestinal tract.

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

K-204 GUIDE SHEATH KIT 2.6MM, model no. K-204 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

Aquarius LPH 511-A CRLF2 Distal Probe Green, model no. LPH 511-A The CRLF2 Distal probe, labelled in green, consists of two probes (71kb and 131kb) that are situated distal (telomeric) to the CRLF2 gene

Cytocell Ltd.

FDA Devices Moderate Feb 17, 2021

B5-2Q BALLOON CATHETER, Model No. B5-2Q - Product Usage: Used with endoscopes to inject contrast medium or other medical fluid into the bile duct, pancreatic duct, and respiratory organs.

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

K-202 GUIDE SHEATH Kit 2.0MM, model no. K-202 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

B7-2Q BALLOON CATHETER 13MM DIA 3.2, model no. B7-2Q -Product Usage: Used with endoscopes for injection of contrast medium or other medical fluid into the biliary or pancreatic tract.

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

INJECTOR FORCEMAX UP 2.8MMCH 25G 6MM, model no. NM-400L-0625 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

KD-650L ELECTROSURGICAL SNARE, model no. KD-650L - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract.

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

PBD-203-0704 BILIARY STENT, model no. PBD-203-0704 -Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage.

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

7 IN (18cm) APPX 0.43ml, SMALLBORE SET, MicroCLAVE, FILTER SetSource - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).

ICU Medical, Inc.

FDA Devices Moderate Feb 17, 2021

NEEDLEMASTER 5MMx 25G LOWER, model no. NM-610U-0525 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

Bemer-Set/ Pro-Set for the following models: REF. 410201 (BEMER Pro-Set), REF. 420201 (B.BOX Professional), REF. 420100 (B.BOX CLASSIC), REF. 410100 (BEMER Classic-Set), REF. 420200 (B.BOX Professional), and REF. 410200 (BEMER Pro - Set)

BEMER INT. AG

FDA Devices Moderate Feb 17, 2021

INJECTOR FORCEMAX UP 2MM CH 23G 3MM, model no. NM-401L-0523 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

INJECTOR FORCEMAX LOWER 23G 6MM 5/BX, model no. NM-400U-0623 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

INJECTOR FORCEMAX UP 2.8MMCH 21G 4MM, model no. NM-400L-0421 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

NA-201SX-4022-ASPIRATION NEEDLE VIZISHOT 22G, model no. NA-201SX-4022-A - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and esophagus.

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

ChemoPlus" Chemo Prep & Admin Kit, CT4025

Cardinal Health 200, LLC

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: USDA FSIS Recalls - calendar-year meat, poultry, and processed egg product recall filings
  • Source: CPSC + NHTSA - consumer product and vehicle recall feeds for 2021

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 2021 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 November 2026.