PlainRecalls

2021 Recalls

5,168 recalls · Page 35 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 1 critical, 47 moderate, and 2 lower-severity recalls. The page references 20 distinct recalling firms operating in 3 distinct product categories, with 50 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (35), FDA Drug (15), 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 Drug Moderate Sep 8, 2021

MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8.5 FL OZ / 250 mL bottle, Made in Mexico, Distributed by SBL Br…

Global Sanitizers LLC

FDA Drug Moderate Sep 8, 2021

Artificial Tears Ointment, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, N…

Akorn, Inc.

FDA Drug Moderate Sep 8, 2021

Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, …

Teva Pharmaceuticals USA

FDA Drug Moderate Sep 8, 2021

CHINA-GEL WHITE (Camphor 3.00%, Menthol 5.00%), A TOPICAL PAIN RELIEVER, packaged in a) 2 oz(56.8g) Tube, 76305-301-13 ; b) 4 oz (113.5 g) jar, UPC …

China Gel Inc

FDA Drug Moderate Sep 8, 2021

Naproxen Sodum Tablets USP 220 mg, (Caplet), Manufactured by: Granules India Limited, Sy.No. 160/A, 161/E, 162, &174/A, Gagillapur Village, Dundig…

Granules USA, Inc.

FDA Drug Moderate Sep 8, 2021

Clopidogrel Tablets, USP, 75 mg, 500-count bottle, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macle…

Macleods Pharma Usa Inc

FDA Drug Moderate Sep 8, 2021

Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale,…

Teva Pharmaceuticals USA

FDA Drug Low Sep 8, 2021

Donepezil HCL Tablets, USP, 5 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd. India, Marketed by: Jubilant Cadista Pharmaceutic…

Jubilant Cadista Pharmaceuticals, Inc.

FDA Drug Low Sep 8, 2021

Lidocaine Ointment USP, 5% Rx Only, Net Wt 35.44 g(1 1/4 oz)packaged in a laminat tube, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-008-…

Teligent Pharma, Inc.

FDA Drug Moderate Sep 8, 2021

MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8 Fl OZ (236 mL) bottle, Manufactured by Asiaticon, S.A. de C.V.…

Global Sanitizers LLC

FDA Drug Moderate Sep 8, 2021

MEDICALLY MINDED ANTIMICROBIAL Hand Sanitizer Gel with Aloe Vera, (Ethyl Alcohol 70% v/v), 10 FL OZ / 300 mL, Manufactured by Grupo V-Klean S.A. de C…

Global Sanitizers LLC

FDA Drug Moderate Sep 8, 2021

CHINA_GEL (Camphor 3.00%, Menthol 5.00%) A TOPICAL PAIN RELIEVER, packaged as a) 2 OZ (56.8g) tube, NDC 76305-300-13; b) 4 OZ (113.5g) jar, UPC 6 …

China Gel Inc

FDA Drug Moderate Sep 8, 2021

Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, …

Teva Pharmaceuticals USA

FDA Drug Moderate Sep 8, 2021

aulief (Organic Camphor 3.00% Organic Menthol 5.00%), topical pain relief, packaged as a) 3.2 oz (90.7g) tube UPC 6 87806 30003 1 NDC 76305-302-01 ; …

China Gel Inc

FDA Drug Critical Sep 8, 2021

MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8.5 FL OZ / 250 mL bottle, Made in Mexico, Distributed by SBL Br…

Global Sanitizers LLC

FDA Devices Moderate Sep 8, 2021

Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 33 cm, Item Code 8888541033P

Covidien, LP

FDA Devices Moderate Sep 8, 2021

Norton Arm Kit, Product Code 711400, (previous product code 031001), Sample Kit S711400

Aspen Surgical Products, Inc.

FDA Devices Moderate Sep 8, 2021

Baxter prismaflex, HF 1000 PAES membrane, REF 107140 Used with Prismaflex or PrisMax control units for continuous fluid management and renal repl…

Baxter Healthcare Corporation

FDA Devices Moderate Sep 8, 2021

Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 44 cm, Item Code 8888541044P

Covidien, LP

FDA Devices Moderate Sep 8, 2021

Palindrome RT Repair Kit 15 FR TAL 55cm, Sterile, Item Code 8888541155

Covidien, LP

FDA Devices Moderate Sep 8, 2021

Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 23 cm, Item Code 8888541023P

Covidien, LP

FDA Devices Moderate Sep 8, 2021

Artis Models with SW version VD12 listed below: Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee MP 10094139 Artis Q floor 10848280 …

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Sep 8, 2021

FaStep COVID-19 IgG/IgM Rapid Test Device Qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole bl…

Versea Diagnostics LLC

FDA Devices Moderate Sep 8, 2021

TRUMATCH CT CUT GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in …

DePuy Orthopaedics, Inc.

FDA Devices Moderate Sep 8, 2021

TRUMATCH CT PIN GUIDE KIT R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in …

DePuy Orthopaedics, Inc.

FDA Devices Moderate Sep 8, 2021

Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 33cm, Item Code 8888541033

Covidien, LP

FDA Devices Moderate Sep 8, 2021

Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 19 cm, Item Code 8888541019P

Covidien, LP

FDA Devices Moderate Sep 8, 2021

EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128

Thera Test Laboratories, Inc.

FDA Devices Moderate Sep 8, 2021

EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129

Thera Test Laboratories, Inc.

FDA Devices Moderate Sep 8, 2021

Palindrome RT Repair Kit 15 FR TAL 44cm, Sterile, Item Code 8888541144

Covidien, LP

FDA Devices Moderate Sep 8, 2021

Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 19 cm, Item Code 8888541019

Covidien, LP

FDA Devices Moderate Sep 8, 2021

Merge Hemo, Software packages 10.2, 10.3, and 10.4

Merge Healthcare, Inc.

FDA Devices Moderate Sep 8, 2021

Palindrome RT Repair Kit 15 FR TAL 33cm, Sterile, Item Code 8888541133

Covidien, LP

FDA Devices Moderate Sep 8, 2021

Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 23 cm, Item Code 8888541023

Covidien, LP

FDA Devices Moderate Sep 8, 2021

Lase DiscectomLase Discectomy Device Kit, Models 1100-002 and 1100-002 SHORTy Device Kit, Models 1100-002

Clarus Medical, Llc

FDA Devices Moderate Sep 8, 2021

TRUMATCH CT FEM CUT TIB PIN R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist i…

DePuy Orthopaedics, Inc.

FDA Devices Moderate Sep 8, 2021

Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 28 cm, Item Code 8888541028P

Covidien, LP

FDA Devices Moderate Sep 8, 2021

Palindrome RT Repair Kit 15 FR TAL 23cm, Sterile, Item Code 8888541123

Covidien, LP

FDA Devices Moderate Sep 8, 2021

Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 55cm, Item Code 8888541055

Covidien, LP

FDA Devices Moderate Sep 8, 2021

CombiDiagnost R90 Software Version R1.0 and R1.1

Philips Medical Systems Gmbh, DMC

FDA Devices Moderate Sep 8, 2021

Baxter PrismaFlex, REF numbers: a) 106696 (M 60 SET) b) 106697 (M 100 SET) Expansion: c) 107144 (TPE2000 SET) d) 115307 (M 150 SET) e) 1153…

Baxter Healthcare Corporation

FDA Devices Moderate Sep 8, 2021

Status COVID-19/Flu Rapid Immunoassay for Direct Detection and Differential Diagnosis of SARS-CoV-2, Influenzas Type A, and Type B Antigens Simulta…

Versea Diagnostics LLC

FDA Devices Moderate Sep 8, 2021

TRUMATCH CT PIN GUIDE FEM R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in …

DePuy Orthopaedics, Inc.

FDA Devices Moderate Sep 8, 2021

Palindrome RT Repair Kit 15 FR TAL 19cm, Sterile, Item Code 8888541119

Covidien, LP

FDA Devices Moderate Sep 8, 2021

smiths medical portex Tracheal Intubation Stylet, REF 100/120/200, 4.0mm OD X 335mm, 10/box, sterile.

Smiths Medical ASD Inc.

FDA Devices Moderate Sep 8, 2021

Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 28 cm, Item Code 8888541028

Covidien, LP

FDA Devices Moderate Sep 8, 2021

DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM, REF DBP-150SOLID145

Cardiovascular Systems Inc

FDA Devices Moderate Sep 8, 2021

Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Qualitative detection and differentiation of IgM and IgG antibodies against …

Versea Diagnostics LLC

FDA Devices Moderate Sep 8, 2021

Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 44cm, Item Code 8888541044

Covidien, LP

FDA Devices Moderate Sep 8, 2021

Jessie Sterile Arm Suspension Kit, Product Code 711300, (previous product code 100401), Sample Kit S711300

Aspen Surgical Products, 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 July 2026.