PlainRecalls

2021 Recalls

Compiled from official public sources by the editorial team.

5,168 recalls · Page 27 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 4 critical, 46 moderate, and 0 lower-severity recalls. The page references 22 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 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.

FDA Devices Moderate Oct 6, 2021

The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches. FSN says Tapered Carotid Patch 920875t

Vascutek, Ltd.

FDA Devices Moderate Oct 6, 2021

Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85

Datascope Corp.

FDA Devices Critical Oct 6, 2021

Omnisound Gel, 250 ml bottle and 5 L container; and EcoGel 200, 250 ml bottle; Manufactured by Eco-Med. For use in ultrasound procedures.

Accelerated Care Plus Corporation

FDA Devices Moderate Oct 6, 2021

BF-P60 OES Bronchofiberscope, Model No. BF-P60

Olympus Corporation of the Americas

FDA Devices Moderate Oct 6, 2021

PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SU

Aesculap Implant Systems LLC

FDA Devices Critical Oct 6, 2021

DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set

Deroyal Industries, Inc. Lafollette

FDA Devices Moderate Oct 6, 2021

Corin Trinity-i, diameter 50mm Taper Size 3, Non-Occluded Ti Plasma Shell, REF 320.03.350, Sterile, a component of the Trinity Acetabular System.

Corin Ltd

FDA Devices Moderate Oct 6, 2021

V1500HP OUTLOOK PUMP SET 118-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Re…

B. Braun Medical, Inc.

FDA Devices Moderate Oct 6, 2021

OUTLOOK PUMP IV SET, 134 IN.-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Re…

B. Braun Medical, Inc.

FDA Devices Moderate Oct 6, 2021

Outlook Pump Add-On Set-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: …

B. Braun Medical, Inc.

FDA Devices Moderate Oct 6, 2021

BF-Q180-AC EVIS EXERA II Bronchovideoscope, Model No. BF-Q180-AC

Olympus Corporation of the Americas

FDA Devices Moderate Oct 6, 2021

FlexoStretch Model Number: 3156057 - The combination of this products allows the user to easily adjust/control the center of gravity during lift of p…

Hill-Rom, Inc.

FDA Devices Moderate Oct 6, 2021

VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged

Greiner Bio-One North America, Inc.

FDA Devices Moderate Oct 6, 2021

uMI 550 System - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, st…

Shanghai United Imaging Healthcare Co., Ltd.

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.