PlainRecalls

2023 Recall Year Insight

Federal agencies issued 6,706 product recalls indexed by PlainRecalls in calendar year 2023. That represents about 6.42% of the 104,423 total recalls we track from 1995 through the present, and averages roughly 18.4 recalls per day across the FDA, CPSC, USDA FSIS, 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 135 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 2023.

On this page of 50 records, severity classification shows 1 critical, 49 moderate, and 0 lower-severity recalls. The page references 18 distinct recalling firms operating in 1 distinct product categories, with 39 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 2023 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, USDA FSIS, or NHTSA for the system-of-record on any specific recall. PlainRecalls indexes this archive for research and consumer awareness purposes.

FDA Devices Moderate Dec 13, 2023

CardioQuip Modular Cooler-Heater, Model:MCH-1000(m), Power: 115V-60hz,16A

CardioQuip, LLC

FDA Devices Moderate Dec 13, 2023

ProCurity bed series, model number 3009, item number: 3009PX-ZMX-600.

Stryker Medical Division of Stryker Corporation

FDA Devices Moderate Dec 13, 2023

ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

Elekta, Inc.

FDA Devices Moderate Dec 13, 2023

NovoTHOR Gen 2.5 Regular whole body red light therapy bed, model S2183

Thor Photomedicine Ltd

FDA Devices Moderate Dec 13, 2023

Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: HITHSP04

Integra LifeSciences Corp.

FDA Devices Moderate Dec 13, 2023

ProCuity bed series, model number 3009, item number: 3009PX-LEX-400.

Stryker Medical Division of Stryker Corporation

FDA Devices Moderate Dec 13, 2023

Monarch Platform REF MON-000005-01R, 100-240V- 50/60Hz 1440w

AURIS HEALTH INC

FDA Devices Moderate Dec 13, 2023

EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.

Staar Surgical Company

FDA Devices Moderate Dec 13, 2023

NovoTHOR Gen 2.0 whole body red light therapy bed, model S1176

Thor Photomedicine Ltd

FDA Devices Moderate Dec 13, 2023

EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.

Staar Surgical Company

FDA Devices Moderate Dec 13, 2023

QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3-E, Order Number G22667; used to dilate strictures of the biliary tree

Wilson-Cook Medical Inc.

FDA Devices Moderate Dec 13, 2023

ProCurity bed series, model number 3009, item number: 3009PX-ZX-450.

Stryker Medical Division of Stryker Corporation

FDA Devices Moderate Dec 13, 2023

DJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 Left 3D MATRIX COATED REF 243-01-108 DJO surgical EMPOWR KNEE", PRESS FIT BP MINUS, 8L REF 353-03-108 For the treatment of patients who are candidates for knee arthroplasty per the Indication for use.

Encore Medical, LP

FDA Devices Moderate Dec 13, 2023

Freedom Boom models series: F110, F120, F130, F320, F330, F350, F410, and F420 with built in 42A Lightweight Spring Arm part numbers 42A-43L, 42A-43M, 42A-43H, and 42A-43S. Ceiling mounted utilities and equipment dispensing system.

IHB OPERATIONS B.V.

FDA Devices Moderate Dec 13, 2023

ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

Elekta, Inc.

FDA Devices Moderate Dec 13, 2023

Integra¿ Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: HITHSP06

Integra LifeSciences Corp.

FDA Devices Moderate Dec 13, 2023

EVO+VISIAN Implantable Collamer Lens, REF:VTICM5_13.7. Phakic Toric Intraocular lens.

Staar Surgical Company

FDA Devices Moderate Dec 13, 2023

HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100

Heartware, Inc.

FDA Devices Moderate Dec 13, 2023

PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104

Heartware, Inc.

FDA Devices Moderate Dec 13, 2023

Integra Cranial Access Kit -For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7270

Integra LifeSciences Corp.

FDA Devices Moderate Dec 13, 2023

Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7260

Integra LifeSciences Corp.

FDA Devices Moderate Dec 13, 2023

EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.6. Phakic Toric Intraocular lens.

Staar Surgical Company

FDA Devices Moderate Dec 13, 2023

PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU

Heartware, Inc.

FDA Devices Critical Dec 13, 2023

CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system.

Maquet Medical Systems USA

FDA Devices Moderate Dec 13, 2023

ProCuity bed series, model number 3009, item number: 3009PX-LE-450.

Stryker Medical Division of Stryker Corporation

FDA Devices Moderate Dec 13, 2023

EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.

Staar Surgical Company

FDA Devices Moderate Dec 13, 2023

ProCurity bed series, model number 3009, item number: 3009PX-ZMX-450.

Stryker Medical Division of Stryker Corporation

FDA Devices Moderate Dec 13, 2023

STERILE HVAD (HeartWare Ventricular Assist Device) PUMP (US), Model Number 1101

Heartware, Inc.

FDA Devices Moderate Dec 13, 2023

HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1102

Heartware, Inc.

FDA Devices Moderate Dec 13, 2023

G041 POD, THOR NOVO GEN 2.0 XL whole body red light therapy bed, model S1177

Thor Photomedicine Ltd

FDA Devices Moderate Dec 13, 2023

ProCuity bed series, model number 3009, item number: 3009PX-Z-450.

Stryker Medical Division of Stryker Corporation

FDA Devices Moderate Dec 13, 2023

Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w

AURIS HEALTH INC

FDA Devices Moderate Dec 13, 2023

NovoTHOR Gen 2.5 XL whole body red light therapy bed, model S2184.

Thor Photomedicine Ltd

FDA Devices Moderate Dec 13, 2023

EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.

Staar Surgical Company

FDA Devices Moderate Dec 13, 2023

EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_13.2. Phakic Toric Intraocular lens.

Staar Surgical Company

FDA Devices Moderate Dec 13, 2023

1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLIN

Heartware, Inc.

FDA Devices Moderate Dec 13, 2023

Integra Cranial Access Kit- For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7250

Integra LifeSciences Corp.

FDA Devices Moderate Dec 13, 2023

Integra¿ Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7280

Integra LifeSciences Corp.

FDA Devices Moderate Dec 13, 2023

RANDOX Total Bilirubin.

Randox Laboratories Ltd.

FDA Devices Moderate Dec 13, 2023

ProCuity bed series, model number 3009, item number: 3009PX-LEX-450.

Stryker Medical Division of Stryker Corporation

FDA Devices Moderate Dec 13, 2023

vyaire Flexible Patient Circuit, 3100A, REF 29028-003, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)

Vyaire Medical

FDA Devices Moderate Dec 13, 2023

ProCuity bed series, model number 3009, item number: 3009PX-ZM-600.

Stryker Medical Division of Stryker Corporation

FDA Devices Moderate Dec 13, 2023

ProCuity bed series, model number 3009, item number: 300900000000,

Stryker Medical Division of Stryker Corporation

FDA Devices Moderate Dec 13, 2023

Remington MEDICAL Drainage Bag, REF 600-D;

Remington Medical, Inc.

FDA Devices Moderate Dec 13, 2023

Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test, REF 20-011-018, a component of the Luminex VERIGENE BC-GP Utility Kit, REF 20-012-018, containing 20 tests.

Luminex Corporation

FDA Devices Moderate Dec 13, 2023

QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3-E, Order Number G22765; used to dilate strictures of the biliary tree

Wilson-Cook Medical Inc.

FDA Devices Moderate Dec 13, 2023

Automated Impella Controller (AIC), product number 0042-000-US with software versions V8.4 and V8.4.1.

Abiomed, Inc.

FDA Devices Moderate Dec 13, 2023

VITROS Chemistry Products ECO2 Slides-For in vitro diagnostic use only. VITROS Chemistry Products ECO2 Slides quantitatively measure total carbon dioxide (CO2) concentration in serum and plasma using VITROS 250/350/5,1 FS/4600 XT 3400 Chemistry Systems and the VITROS 5600/ XT 7600 Integrated System. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance. Product Code: 8262396

Ortho-Clinical Diagnostics, INc.

FDA Devices Moderate Dec 13, 2023

Combo Kit Consists OF 10-110/INS-4500/INS-7040- For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: 31004

Integra LifeSciences Corp.

FDA Devices Moderate Dec 13, 2023

ProCuity bed series, model number 3009, item number: 3009PX-L-200

Stryker Medical Division of Stryker Corporation

Nearby Recall Years

Browse recalls from adjacent calendar years to see how federal enforcement volume has shifted over time.

Compare 2023 with 2022 →

Data Sources

  • Source: FDA openFDA Enforcement API - calendar-year recall filings for food, drugs, and devices
  • Source: USDA FSIS Recalls - calendar-year meat, poultry, and processed egg product recall filings
  • Source: CPSC + NHTSA - consumer product and vehicle recall feeds for 2023

Every figure on PlainRecalls is rendered directly from official FDA, CPSC, USDA FSIS and NHTSA recall records; no number is typed in by an editor. Figures cover calendar year 2023 across the FDA, CPSC, USDA FSIS 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 September 2026.