PlainRecalls

2021 Recalls

4,225 recalls · Page 23 of 85

2021 Recall Year Insight

Federal agencies issued 4,225 product recalls indexed by PlainRecalls in calendar year 2021. That represents about 5.03% of the 83,949 total recalls we track from 1995 through the present, and averages roughly 11.6 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 85 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, 47 moderate, and 0 lower-severity recalls. The page references 22 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 (47), CPSC (2), FDA Drug (1), 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, NHTSA, or USDA FSIS for the system-of-record on any specific recall. PlainRecalls indexes this archive for research and consumer awareness purposes.

FDA Drug Moderate Oct 6, 2021

ZTE 1015 Formula, Contents 1000 ml, For Manufacturing Use only, REMEDY: Argentum Nitricum 10X, Rhus Toxicodendron 10X, Aurum Metallicum 10X, Iris Ver…

Washington Homeopathic Products, Inc.

FDA Devices Moderate Oct 6, 2021

Corin Unity Knee CS Insert, Size 5 / 9.0mm, Fixed Condylar Stabilised - UHMWPE, REF 1125182, Sterile, and Corin Unity Knee CS Insert, Size 8 / 10.0m…

Corin Ltd

FDA Devices Moderate Oct 6, 2021

Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000

WOM World of Medicine AG

FDA Devices Moderate Oct 6, 2021

Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0…

Datascope Corp.

FDA Devices Moderate Oct 6, 2021

Corin BIOLOX Delta Mod Head, diameter 28mm Medium 0mm, 12/14 Taper, REF 104.2805, Sterile, a component of the Trinity Acetabular System.

Corin Ltd

FDA Devices Moderate Oct 6, 2021

LYMOL Medical Elite X Class Rigid Bronchoscope System, Part No. BD2410, BB2701, BB2702, BB2401, BB2402, BA2700, BT2000, BT2101, BT2103, BT2105, BT210…

Lymol Medical Corporation

FDA Devices Moderate Oct 6, 2021

Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and po…

Deerfield Imaging, Inc.

FDA Devices Moderate Oct 6, 2021

The Instructions for Use (IFU) for: Gelsoft Plus Bifurcate, Gelsoft Plus Ax-Fem, GelsoftPlus ERS Ax-Fem, Gelweave Straight, Gelweave Trifurcate, Gel…

Vascutek, Ltd.

FDA Devices Moderate Oct 6, 2021

Arjo Citadel beds originally assembled with the IndiGo modules during manufcturing, model number CX812A3J3AMAD0; and IndiGo modules (retrofit kits) t…

ARJOHUNTLEIGH POLSKA Sp. z.o.o.

FDA Devices Critical Oct 6, 2021

EcoLotion Transmission Lotion, used in ultrasound procedures. Item/Description: NC70481/Eco Lotion 5 liters, NC70482/Eco Lotion with Aloe 5 liters, …

North Coast Medical Inc

FDA Devices Moderate Oct 6, 2021

Corin MetaFix Hip Stem, Size 1, Short Neck, 135 degrees, Collared Hip Stem, REF 579.0201, Sterile.

Corin Ltd

FDA Devices Moderate Oct 6, 2021

Atrium ADVANTA VXT Vascular Graft, Part No. 22059, UDI 00650862220599 - Product Usage: intended for use in arterial vascular reconstruction, segmenta…

Atrium Medical Corporation

FDA Devices Moderate Oct 6, 2021

DuoDERM Control Gel Formula Border Dressings 15x15cm (1x5pk)

ConvaTec, Inc

FDA Devices Moderate Oct 6, 2021

PUMP SET, 15 DR, 3 CARESITE, 127 in.single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral flu…

B. Braun Medical, Inc.

FDA Devices Moderate Oct 6, 2021

BF-XP60 OES Bronchofiberscope, Model No. BF-XP60

Olympus Corporation of the Americas

FDA Devices Moderate Oct 6, 2021

Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusive Model: 086-330.

Biodex Medical Systems, Inc.

FDA Devices Moderate Oct 6, 2021

uEXPLORER PET/CT System - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization, diag…

Shanghai United Imaging Healthcare Co., Ltd.

FDA Devices Moderate Oct 6, 2021

MOSAIQ Oncology Information System

Elekta, Inc.

FDA Devices Moderate Oct 6, 2021

BF-1T180 EVIS EXERA II Bronchovideoscope, Model No. BF-1T180

Olympus Corporation of the Americas

FDA Devices Moderate Oct 6, 2021

NAMIC Stopcocks: (1) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015002, UPN H965700150021, Three-way Stopcock with Rotating Collar, Rx only, Sterile;…

Medline Industries Inc

FDA Devices Moderate Oct 6, 2021

Corin TriFit TS, Size 8, Standard Tapered Stem, REF 694.0008, Sterile.

Corin Ltd

FDA Devices Moderate Oct 6, 2021

Outlook Pump Measured Volume Solution Set/ w/ Auto Shut-Off. Single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for i…

B. Braun Medical, Inc.

FDA Devices Moderate Oct 6, 2021

15 drops/ml, Priming Volume: 27ml, Length: 129 in. Single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of…

B. Braun Medical, Inc.

FDA Devices Moderate Oct 6, 2021

BF-3C40 OES Bronchofiberscope, Model No. BF-3C40

Olympus Corporation of the Americas

FDA Devices Moderate Oct 6, 2021

DxA 5000 (DxA Automation System, DxA 5000 fit), "For in Vitro Diagnostic Use", Reference Numbers: B87352 with B57634, UDI: 15099590707118

Beckman Coulter Inc.

FDA Devices Moderate Oct 6, 2021

LikoStretch Mod 600 IC Model Number: 3156065 LikoStretch Mod 600 IC, Wide Model Number: 3156065B (obsolete since 12JUN2020) - The combination of thi…

Hill-Rom, Inc.

FDA Devices Moderate Oct 6, 2021

Outlook Pump Primary Administration Set w/ micro Tubing for Epidural Administration-single use, for use with the Outlook Safety Infusion System and/o…

B. Braun Medical, Inc.

FDA Devices Moderate Oct 6, 2021

OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenter…

B. Braun Medical, Inc.

FDA Devices Moderate Oct 6, 2021

Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and po…

Deerfield Imaging, Inc.

FDA Devices Moderate Oct 6, 2021

BF-XT160 EVIS EXERA Bronchovideoscope, Model No. BF-XT160

Olympus Corporation of the Americas

FDA Devices Moderate Oct 6, 2021

OUTLOOK PUMP IV SET W/UNIVERSAL SPIKE-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral f…

B. Braun Medical, Inc.

FDA Devices Moderate Oct 6, 2021

Corin Unity Knee Patella, Size 3 / 8.5mm, Centered Dome 3 PEG-UHMWPE, REF 112.018.06, Sterile, a component of the Unity Total Knee System.

Corin Ltd

FDA Devices Moderate Oct 6, 2021

LikoStretch 1900 Model Number: 3156051 - The combination of this products allows the user to easily adjust/control the center of gravity during lift …

Hill-Rom, Inc.

FDA Devices Moderate Oct 6, 2021

Corin Unity Knee Augments, Size 5, 6 & 7 / 10mm Thick, Femoral Posterior Augment, REF 1122370, Sterile, a component of the Unity Total Knee System.

Corin Ltd

FDA Devices Moderate Oct 6, 2021

AtomLab 500Plus Dose CalibratorSoftware 2.0.00 through Revision 2.0.08, inclusive Model: 086-332

Biodex Medical Systems, Inc.

FDA Devices Moderate Oct 6, 2021

Vysis CLL FISH Probe Kit with the following components: Vysis LSI p53 SpectrumOrange/ATM, SpectrumGreen and LSI D13S319, SpectrumOrange/ 13q34, Spect…

Abbott Molecular, Inc.

FDA Devices Critical Oct 6, 2021

Imperative Care, ZOOM 71 Reperfusion Catheter, REF: ICRC071137, TRX Tip, 137 cm, 6F (.083 in/2.11 mm), .071 in/1.8 mm), STERILE.EO, Rx Only, UDI: (0…

IMPERATIVE CARE INC

FDA Devices Moderate Oct 6, 2021

Y-Type Blood, Outlook Pump Set, Caresite-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parentera…

B. Braun Medical, Inc.

FDA Devices Moderate Oct 6, 2021

Atrium Pneumostat Chest Drain Valve, Part Number 16100

Atrium Medical Corporation

FDA Devices Moderate Oct 6, 2021

Stretch Leveller Model Number: 3156200 - The combination of this products allows the user to easily adjust/control the center of gravity during lift …

Hill-Rom, Inc.

FDA Devices Moderate Oct 6, 2021

60 drops/ml, Priming volume: 25 ml, Length: 120 in.in-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion…

B. Braun Medical, Inc.

FDA Devices Moderate Oct 6, 2021

BF-1T60 OES Bronchofiberscope, Model No. BF-1T60

Olympus Corporation of the Americas

FDA Devices Moderate Oct 6, 2021

BF-N20 OES Bronchofiberscope, Model No. BF-N20

Olympus Corporation of the Americas

FDA Devices Critical Oct 6, 2021

Norco Ultrasound Gel, Item/Description: NC70479/Norco Ultrasound Gel, 250 mL; NC70479/North Coast Ultrasound Gel, 250 mL; NC70479-5/Norco Ultrasound …

North Coast Medical Inc

FDA Devices Moderate Oct 6, 2021

Outlook Pump Blood Administration Set with SAFELINE Injection Site-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pum…

B. Braun Medical, Inc.

FDA Devices Moderate Oct 6, 2021

ET82HP OUTLOOK PUMP EXTENSION SET-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluid…

B. Braun Medical, Inc.

FDA Devices Moderate Oct 6, 2021

Flow sensors that may be installed in the following GEHC anesthesia machines: (1) Aestiva MRI, GTIN 0080682102339; (2) Aestiva 7900; (3) Aestiva…

GE Healthcare, LLC

FDA Devices Moderate Oct 6, 2021

10 drops/ml, Priming volume: 46ml, Length: 130 in.-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of…

B. Braun Medical, Inc.

CPSC Moderate Oct 6, 2021

ElliptiGO Recalls Arc Model Stand-Up Bicycles Due to Fall and Injury Hazards

CPSC Moderate Oct 6, 2021

Hobby Lobby Recalls White Wood Stools Due to Fall and Injury Hazards

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 + USDA FSIS — consumer product, vehicle, and meat/poultry recall feeds for 2021