PlainRecalls

2021 Recalls

5,086 recalls · Page 75 of 102

2021 Recall Year Insight

Federal agencies issued 5,086 product recalls indexed by PlainRecalls in calendar year 2021. That represents about 6.06% of the 83,949 total recalls we track from 1995 through the present, and averages roughly 13.9 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 102 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 3 critical, 46 moderate, and 1 lower-severity recalls. The page references 19 distinct recalling firms operating in 4 distinct product categories, with 50 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (44), FDA Drug (4), FDA Food (2), 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 Food Low Apr 28, 2021

Thai Home brand Green Curry Paste packaged in glass jars. Net weight 6.5 oz (180g). Refrigerate after opening. UPC 8616080004023. Manufactur…

Jansala & Foods LLC

FDA Food Critical Apr 28, 2021

Real Alkalized Water, packed in 16.9 oz., 1 Liter, 1.5 Liter, 1-Gallon and 5-Gallon plastic bottles. Drinkrealwater.com

Real Water, Inc.

FDA Drug Moderate Apr 28, 2021

Estradiol Transdermal System Delivers 0.0375 mg/day, 8 Systems/box, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. by: Nov…

Noven Pharmaceuticals Inc

FDA Drug Moderate Apr 28, 2021

Minivelle (estradiol transdermal system) Delivers 0.075 mg/day, 8 patches/box, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Di…

Noven Pharmaceuticals Inc

FDA Drug Moderate Apr 28, 2021

Flurandrenolide Ointment USP, 0.05%, Net Wt. 60 grams, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310 NDC 52565-017-60

Teligent Pharma, Inc.

FDA Drug Moderate Apr 28, 2021

Betadine (Povidone-Iodine) 5%, 0.5mL per syringe Single Use Syringe Rx only, For Topical Ophthalmic Use (DO NOT INJECT) STERILE OPHTHALMIC SOLUTION, …

Edge Pharma, LLC

FDA Devices Moderate Apr 28, 2021

Tubing with male luer lock adapter (Component) a. 76 cm, REF 601280 b. 122 cm, REF 607281. component of extravascular blood-pressure Transducer.

Smiths Medical ASD Inc.

FDA Devices Moderate Apr 28, 2021

Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartware HVAD pump implant kits Models 1100, 1101, 1…

Heartware, Inc.

FDA Devices Moderate Apr 28, 2021

BIOTRONIK Ilestro 7 VR-T, DF-1, REF 383578, UDI: 04035479125349 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular d…

BIOTRONIK Inc

FDA Devices Moderate Apr 28, 2021

AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer Catalogue #: VI10 - Product Usage: For the introduction of various ty…

Angiodynamics Inc. (Navilyst Medical Inc.)

FDA Devices Moderate Apr 28, 2021

Left Heart Kit, Model Number M20268. for blood pressure monitoring.

Smiths Medical ASD Inc.

FDA Devices Moderate Apr 28, 2021

Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartware HVAD pump implant kits Models 1100, 1101, 110…

Heartware, Inc.

FDA Devices Moderate Apr 28, 2021

Stopcock rotator (Component): a. 1050 STOPCOCK ROTATOR, OFF HANDLE, Model Number MX1431MR b. 1050 STOPCOCK LEFT ROTATOR, OFF HANDLE, Model Number M…

Smiths Medical ASD Inc.

FDA Devices Moderate Apr 28, 2021

LogiCal Monitoring Set, Model Number DPS564898. for blood pressure monitoring and blood sampling.

Smiths Medical ASD Inc.

FDA Devices Moderate Apr 28, 2021

LogiCal Left Heart Kit, Model Number M20553. for blood pressure monitoring.

Smiths Medical ASD Inc.

FDA Devices Moderate Apr 28, 2021

Manifold rotator (Component): a. 250 2 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number MX1232MR b. 250 3 GANG MANIFOLD ROTATOR, OFF HANDLE, Model N…

Smiths Medical ASD Inc.

FDA Devices Moderate Apr 28, 2021

BCS XP System: Multipurpose system for in vitro coagulation studies. Product code: 10459330, 10461894, 10470625 - Product Usage: The Behring Coagulat…

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Apr 28, 2021

Surveyor S12/S19 Bedside Patient Monitor, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product…

Welch Allyn Inc Mortara

FDA Devices Moderate Apr 28, 2021

BIOTRONIK Ilestro 7 VR-T DX, DF-1, REF 383594, UDI: 04035479125509 - Product Usage: intended to provide ventricular tachycardia pacing and ventricula…

BIOTRONIK Inc

FDA Devices Moderate Apr 28, 2021

Bard Clean-Cath Intermittent Catheter, 12 French female length (catheter, urological) - Product Usage: for urological use only.

C.R. Bard, Inc.

FDA Devices Moderate Apr 28, 2021

DirectInject consists of a sterile dual paste system which is calcium phosphate based. Upon injection through the Mixer-Cannula, the two pastes form …

Stryker Leibinger GmbH & Co. KG

FDA Devices Moderate Apr 28, 2021

BIOTRONIK INVENTRA 7, HF-T QP DF4 IS4, REF 393012, UDI: 04035479129286 - Product Usage: intended to provide ventricular tachycardia pacing and ventr…

BIOTRONIK Inc

FDA Devices Moderate Apr 28, 2021

The AMS 700 Inflatable Penile Prosthesis is a closed fluid-filled system containing saline. The system is made out of silicone and consists of 4 mai…

Boston Scientific Corporation

FDA Devices Moderate Apr 28, 2021

AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatri…

Welch Allyn Inc Mortara

FDA Devices Moderate Apr 28, 2021

BIOTRONIK ILIVIA NEO 7 DR-T DF-1 ProMRI, REF 429529, UDI: 04035479156749 - Product Usage: intended to provide ventricular tachycardia pacing and vent…

BIOTRONIK Inc

FDA Devices Moderate Apr 28, 2021

Gang Cath Lab Set, Model Number M20858R1.for the administration of IV fluids. Stopcocks and manifolds are used to control the direction of IV fluid …

Smiths Medical ASD Inc.

FDA Devices Moderate Apr 28, 2021

Tritanium X TL Instruments - intervertebral fusion device with bone graft, lumbar. Catalogs:TL Inserter (580220100), TL Draw Rod (580220101), Tube Se…

Stryker Spine

FDA Devices Moderate Apr 28, 2021

Smart Port CT-Implantable Port Catalogue #: CT96STSD-VI, CT96STSA-VI - Product Usage: indicated for any patient requiring repeated access of the vasc…

Angiodynamics Inc. (Navilyst Medical Inc.)

FDA Devices Moderate Apr 28, 2021

Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Large, 8 mm, Product Number 5146-1608-N - Product Usage: indicated…

Medtronic Sofamor Danek USA, Inc

FDA Devices Moderate Apr 28, 2021

Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Small, 8 mm, Product Number 5146-1208-N - Product Usage: indicated…

Medtronic Sofamor Danek USA, Inc

FDA Devices Moderate Apr 28, 2021

Medex 10 IN Pressure Injector Line w/Rot (1200psi) NS. REF B1681R, component of extravascular blood-pressure Transducer.

Smiths Medical ASD Inc.

FDA Devices Moderate Apr 28, 2021

BIOTRONIK ITREVIA 7, VR-T DF-4, REF 393041, UDI: 04035479129569 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular d…

BIOTRONIK Inc

FDA Devices Moderate Apr 28, 2021

BIOTRONIK Ilestro 7 DR-T, DF-1, REF383562, UDI: 04035479125189 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular de…

BIOTRONIK Inc

FDA Devices Moderate Apr 28, 2021

BIOTRONIK ILIVIA 7, VR-T DF4 ProMRI, REF 404626, UDI: 04035479142131 - Product Usage: intended to provide ventricular tachycardia pacing and ventric…

BIOTRONIK Inc

FDA Devices Moderate Apr 28, 2021

BIOTRONIK ITREVIA 7, VR-T DF-1, REF 393040, UDI: 04035479129552 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular d…

BIOTRONIK Inc

FDA Devices Moderate Apr 28, 2021

BIOTRONIK IPERIA 7,VR-T, DX, DF-1, ProMRI, REF 393032, UDI: 04035479129477 - Product Usage: intended to provide ventricular tachycardia pacing and ve…

BIOTRONIK Inc

FDA Devices Moderate Apr 28, 2021

HIGH PRESSURE ROTATOR (Component) a. WITH MALE LUER LOCK, Model Number MX496HP b. WITH FEMALE LUER LOCK, Model Number MX497HP. component of ext…

Smiths Medical ASD Inc.

FDA Devices Moderate Apr 28, 2021

Midline Catheter Dressing Change Kit with Statlock - Product Usage: Intended to provide ongoing vascular catheter maintenance (e.g., dressing change,…

Trinity Sterile, Inc.

FDA Devices Moderate Apr 28, 2021

BIOTRONIK Ilestro 7 VR-T, DF-4, REF 383580, UDI: 04035479125363 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular d…

BIOTRONIK Inc

FDA Devices Moderate Apr 28, 2021

HIGH PRESSURE TUBING, 72IN, Model Number MX152114 (Component). Stopcocks and manifolds are used to control the direction of IV fluid flow.

Smiths Medical ASD Inc.

FDA Devices Critical Apr 28, 2021

Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel, installed by Pacific Medical Group (DBA Avante Health Solutions)

Pacific Medical Group Inc.

FDA Devices Moderate Apr 28, 2021

BIOTRONIK Ilestro 7 DR-T, DF-4, REF383564, UDI: 04035479125202 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular de…

BIOTRONIK Inc

FDA Devices Critical Apr 28, 2021

Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these system components: HVAD Sterile Implant Kit, Model Numbers: 11…

Heartware, Inc.

FDA Devices Moderate Apr 28, 2021

BIOTRONIK ILIVIA 7, DR-T DF-1 PROMRI, REF 404622, UDI: 04035479142094 - Product Usage: intended to provide ventricular tachycardia pacing and ventric…

BIOTRONIK Inc

FDA Devices Moderate Apr 28, 2021

BIOTRONIK ITREVIA 7, DR-T QP DF-1, REF 392412, UDI: 04035479128807 - Product Usage: intended to provide ventricular tachycardia pacing and ventricul…

BIOTRONIK Inc

FDA Devices Moderate Apr 28, 2021

BIOTRONIK Iforia 7,DR-T, DF-1,REF 390064, UDI: 04035479126926 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular def…

BIOTRONIK Inc

FDA Devices Moderate Apr 28, 2021

BIOTRONIK ILIVIA 7, DR-T DF4 ProMRI, REF 404623, UDI: 04035479142100 - Product Usage: intended to provide ventricular tachycardia pacing and ventric…

BIOTRONIK Inc

FDA Devices Moderate Apr 28, 2021

BIOTRONIK INTICA NEO 7 HF-T DF-1 IS-1 ProMRI, REF 429553, UDI: 04035479156831 - Product Usage: intended to provide ventricular tachycardia pacing and…

BIOTRONIK Inc

FDA Devices Moderate Apr 28, 2021

Sensis/ Sensis Vibe Hemo systems with VD12A software as follows: Dedicated SIS Server- 6648153 Sensis Post-Processing Workstation- 6648161 Sensi…

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Apr 28, 2021

BIOTRONIK Iforia 7, vr-T, DX, DF-1,REF 390090, UDI: 04035479127176 - Product Usage: intended to provide ventricular tachycardia pacing and ventricula…

BIOTRONIK 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