PlainRecalls

2021 Recalls

5,168 recalls · Page 41 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 8 critical, 42 moderate, and 0 lower-severity recalls. The page references 18 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 Aug 18, 2021

Grasper/Retriever, Alligator Jaw 2.4 mm x 5 mm x 230 cm Catalog Number: 7208 Intended use: single use accessory devices used through the working …

Shent USA, Inc.

FDA Devices Moderate Aug 18, 2021

Medline Arthroscopy Kit, convenience kit, REF DYNJ904304B, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020).

Medline Industries Inc

FDA Devices Moderate Aug 18, 2021

Prime Big Wheel Stretcher-used as a short-term outpatient clinical evaluation, treatment, minor procedure, and short-term outpatient recovery platfor…

Stryker Medical Division of Stryker Corporation

FDA Devices Moderate Aug 18, 2021

TJM6008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 8G x 15 cm; TJC3513 Jamshidi" Bone Marrow Biopsy/Aspira…

Bard Peripheral Vascular Inc

FDA Devices Moderate Aug 18, 2021

Simpleware ScanIP software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical trea…

Simpleware Product Group, SYNOPSYS NORTHERN EUROPE

FDA Devices Critical Aug 18, 2021

HeartWare HVAD Pump Implant Kit, REF 1153

Heartware, Inc.

FDA Devices Moderate Aug 18, 2021

S3 MedSurg Bed - intended to support and transport patients within the Med/Surg and Critical Care hospital environments, Model Number: 3005, Part # 3…

Stryker Medical Division of Stryker Corporation

FDA Devices Critical Aug 18, 2021

HeartWare HVAD Outflow Graft, REF MCS1725OG

Heartware, Inc.

FDA Devices Moderate Aug 18, 2021

Michael Graves with Stryker Highback Chair-intended for pediatric and adult person guest and patient seating use in an indoor medical setting, Model …

Stryker Medical Division of Stryker Corporation

FDA Devices Moderate Aug 18, 2021

Arcos Modular Revision Hip System Standard Cone Prox Body, Size C, 80 MM Item Number: 11-301343

Biomet, Inc.

FDA Devices Moderate Aug 18, 2021

Simpleware ScanIP medical software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surg…

Simpleware Product Group, SYNOPSYS NORTHERN EUROPE

FDA Devices Moderate Aug 18, 2021

Arcos Modular Revision Hip System High Offset Cone Prox Body, Size D, 60 MM Item Number: 11-301314

Biomet, Inc.

FDA Devices Moderate Aug 18, 2021

InTouch 2131-intended to support a human patient in an acute care setting, Model Number: 2131000000, Part #1460000000¿¿¿¿¿¿¿

Stryker Medical Division of Stryker Corporation

FDA Devices Moderate Aug 18, 2021

Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 70 MM Item Number: 11-301321

Biomet, Inc.

FDA Devices Moderate Aug 18, 2021

Exactech BIOLOX delta Femoral Head, 36m O.D. + 3.5mm, REF 170-36-03. Hip prosthesis component.

Exactech, Inc.

FDA Devices Moderate Aug 18, 2021

Exactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00. Hip prosthesis component.

Exactech, Inc.

FDA Devices Moderate Aug 18, 2021

ACCESS SARS-CoV-2 ANTIGEN QC, REF: C68670, CONTENTS: 3 X 6.0 mL QC1, 3 x 6.0 mL QC2, 1 QC VALUE CARD, IVD, Rx Only, UDI: (01)15099590742737;

Beckman Coulter Inc.

FDA Devices Critical Aug 18, 2021

HeartWare HVAD Pump Accessories, REF MCS1753AK

Heartware, Inc.

FDA Devices Moderate Aug 18, 2021

Edwards PediaSat Oximetry Catheter Set, REF: XT3515SJ, Exterior Diameter 5.5F, Usable Length 15 cm, Number of Lumens: 3, Rx Only, Sterile EO, UDI: (…

Edwards Lifesciences, LLC

FDA Devices Moderate Aug 18, 2021

The device is a 25-gauge infusion line that is part of 25-gauge surgical pack labeled TDC Vitrectomy Pack VGPC 25g, Product Number 8525.201.

Dutch Ophthalmic USA, Inc.

FDA Devices Moderate Aug 18, 2021

ACCESS SARS-CoV-2 ANTIGEN EXTRACTION SOLUTION, CONTENTS: 6 x 6.0 mL EXTRACTION SOLN, IVD, Rx Only, UDI: (01)15099590743017

Beckman Coulter Inc.

FDA Devices Moderate Aug 18, 2021

S3 MedSurg Bed - intended to support and transport patients within the Med/Surg and Critical Care hospital environments, Model Number 3002, Part 3002…

Stryker Medical Division of Stryker Corporation

FDA Devices Moderate Aug 18, 2021

Medline Knee Arthroscopy Kit, convenience kit, REF DYNJ902838C, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020).

Medline Industries Inc

FDA Devices Moderate Aug 18, 2021

Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 70 MM Item Number: 11-301331

Biomet, Inc.

FDA Devices Critical Aug 18, 2021

Dose IQ Safety Software used with Spectrum IQ Infusion Pump

Baxter Healthcare Corporation

FDA Devices Moderate Aug 18, 2021

Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 60 MM Item Number: 11-301311

Biomet, Inc.

FDA Devices Moderate Aug 18, 2021

Edwards PediaSat Oximetry Catheter Set, REF: XT358SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 9 cm, Number of Lumens: 3, Recommended Guidewir…

Edwards Lifesciences, LLC

FDA Devices Moderate Aug 18, 2021

Edwards PediaSat Oximetry Catheter Kit, REF: XT3515KTP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm, Number of Lumens 3, Recommended Guidew…

Edwards Lifesciences, LLC

FDA Devices Moderate Aug 18, 2021

Transport Stretcher 747 - a non-powered, wheeled device designed to support patients in a horizontal position, Part Number 0747000000

Stryker Medical Division of Stryker Corporation

FDA Devices Moderate Aug 18, 2021

EJM4011 Jamshidi Evolve" Bone Marrow Biopsy/Aspiration Needle with Specimen Cradle. 11G x 10cm

Bard Peripheral Vascular Inc

FDA Devices Moderate Aug 18, 2021

Prelude SNAP Splittable Sheath Introducer, REF: PLSX -1010, size 10F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, (01) 00884450489611. For t…

Merit Medical Systems, Inc.

FDA Devices Moderate Aug 18, 2021

CUB Pediatric Crib- intended to provide a pediatric patient support surface for medical purposes and to provide a method of transporting pediatric pa…

Stryker Medical Division of Stryker Corporation

FDA Devices Moderate Aug 18, 2021

Stretcher Chair-for use in all acute care hospitals and medical outpatient services Model Number: 5050¿¿¿¿ Part # 5050000000

Stryker Medical Division of Stryker Corporation

FDA Devices Moderate Aug 18, 2021

ACCESS SARS-CoV-2 Antigen , REF: C68668, IVD, Rx only, UDI: (01) 15099590742713;

Beckman Coulter Inc.

FDA Devices Moderate Aug 18, 2021

ComfortGel - assists in the prevention and treatment of all pressure injury stages, Model Number 2850, Part # 2850000999, 2850000001, 2850000009

Stryker Medical Division of Stryker Corporation

FDA Devices Moderate Aug 18, 2021

Arcos Modular Revision Hip System High Offset Cone Prox Body, Size B, 60 MM Item Number: 11-301312

Biomet, Inc.

FDA Devices Moderate Aug 18, 2021

Symmetry Plus Treatment Recliner - general hospital use as a convenient seating surface for patients or guests to sit, Model Number 3500, Part # 3500…

Stryker Medical Division of Stryker Corporation

FDA Devices Moderate Aug 18, 2021

smith&nephew BHR SQUARE HEADED NAIL, REF CATALOG NUMBER 999908. For use during orthopedic surgery.

Smith & Nephew Orthopaedics Ltd. (Aurora)

FDA Devices Moderate Aug 18, 2021

Arcos Modular Revision Hip System High Offset Cone Prox Body, Size E, 70 MM Item Number: 11-301335

Biomet, Inc.

FDA Devices Moderate Aug 18, 2021

Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 50 MM Item Number: 11-301310

Biomet, Inc.

FDA Devices Moderate Aug 18, 2021

Kaluza C Flow Cytometry Software Versions: 1.0*, 1.1.1 and 1.1.2 Kits: C10574 - Kaluza C Single Perpetual License C10575 - Kaluza C Single User 1…

Beckman Coulter, Inc.

FDA Devices Moderate Aug 18, 2021

Cannulated graduated drill bit 1.9 mm diameter, with AO QC system, REF: INS-114 for use in orthopedic surgery.

NEOSTEO

FDA Devices Critical Aug 18, 2021

HeartWare HVAD Driveline Extension Cable, REF 100

Heartware, Inc.

FDA Devices Critical Aug 18, 2021

HeartWare HVAD Pump Implant Kit, REF 1103

Heartware, Inc.

FDA Devices Moderate Aug 18, 2021

Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 80 MM Item Number: 11-301342

Biomet, Inc.

FDA Devices Critical Aug 18, 2021

HeartWare HVAD Pump Implant Kit, REF 1104

Heartware, Inc.

FDA Devices Critical Aug 18, 2021

Alaris Infusion Pump Module, Model 8100, serviced/repaired by Biomedical Equipment Service Co. (BMES) with an impacted bezel repair part TIPA-8100-44…

BioMedical Equipment Service Co (BMES)

FDA Devices Moderate Aug 18, 2021

Arcos Modular Revision Hip System High Offset Cone Prox Body, Size C, 70 MM Item Number: 11-301333

Biomet, Inc.

FDA Devices Moderate Aug 18, 2021

Arcos Modular Revision Hip System High Offset Cone Prox Body, Size E, 60 MM Item Number: 11-301315

Biomet, Inc.

FDA Devices Moderate Aug 18, 2021

ETEST IMIPENEM RELEBACTAM. in vitro diagnostic

Biomerieux 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.