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 7 critical, 43 moderate, and 0 lower-severity recalls. The page references 16 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 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 Sep 6, 2023

Olympus Bronchovideoscope, Models BF-3C40 & BF-N20.

Olympus Corporation of the Americas

FDA Devices Moderate Sep 6, 2023

epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1

Siemens Healthcare Diagnostics Inc

FDA Devices Critical Sep 6, 2023

Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-UC-0800-52, 0998-00-0800-53, 0998-UC-0800-53, 0998-00-0800-55, 0998-UC-0800-55, 0998-00-0800-65

Datascope Corp.

FDA Devices Moderate Sep 6, 2023

LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray part number: 5800-1000. Note: The 5800-1000 model number is an individually packaged component contained within the Kit numbers: 5830-2916 LS TANDEMLIFE KIT DL29 5840-2417 LS TANDEMLIFE KIT - V24, A17

Cardiac Assist, Inc

FDA Devices Critical Sep 6, 2023

Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-UC-0800-52, 0998-00-0800-53, 0998-UC-0800-53, 0998-00-0800-55, 0998-UC-0800-55, 0998-00-0800-65

Datascope Corp.

FDA Devices Moderate Sep 6, 2023

Oculus Pentacam AXL , Ref 70100, CE 0123

Oculus Optikgeraete GMBH

FDA Devices Moderate Sep 6, 2023

Atellica CH Triglycerides (concentrated)-In vitro diagnostic use in the quantitative measurement of triglycerides in human serum and plasma (lithium heparin, potassium EDTA) using the Atellica CH Analyzer SMN: 11097591

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Sep 6, 2023

Olympus Bronchovideoscope, Models BF-3C160.

Olympus Corporation of the Americas

FDA Devices Moderate Sep 6, 2023

Olympus Tracheal Intubation Fiberscope, Models LF-P & LF-V.

Olympus Corporation of the Americas

FDA Devices Moderate Sep 6, 2023

Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human serum and plasma (lithium heparin Test Code: GGT Siemens Material Number (SMN): 11097597

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Sep 6, 2023

Atellica¿ CH HDL Cholesterol- In vitro diagnostic use in the quantitative determination of HDL cholesterol in human serum and plasma (lithium heparin, EDTA, sodium Heparin) Test Code: HDLC Siemens Material Number (SMN): 11537213

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Sep 6, 2023

Atellica CH LDL Cholesterol Direct (DLDL)-In vitro diagnostic quantitative determination of LDL cholesterol in human serum and plasma (lithium heparin) using the Atellica CH Analyzer. SMN: 11097632

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Sep 6, 2023

Olympus Bronchovideoscope, Models BF-1T150, BF-1T60, BF-MP60, BF-P150, BF-P60, BF-PE2, BF-TE2, BF-XT160.

Olympus Corporation of the Americas

FDA Devices Moderate Sep 6, 2023

Olympus Bronchovideoscope, Models BF-MP160F, BF-XP160F, BF-XP60.

Olympus Corporation of the Americas

FDA Devices Critical Sep 6, 2023

Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-UC-0800-52, 0998-00-0800-53, 0998-UC-0800-53, 0998-00-0800-55, 0998-UC-0800-55, 0998-00-0800-65, 0998-00-0800-36, 0998-UC-0800-32, 0998-UC-0800-34, 0998-UC-0800-35, 0998-UC-0800-36, 0998-UC-0800-45, 0998-UC-0800-65,

Datascope Corp.

FDA Devices Moderate Sep 6, 2023

GS70H Salus Surgical Table, Product Code 18-071-70

Skytron, LLC

FDA Devices Moderate Sep 6, 2023

Atellica CH Total Protein II- In vitro diagnostic use in the quantitative determination of total protein in human serum and plasma (lithium heparin) using the Atellica CH Analyzer. SMN: 11097604

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Sep 6, 2023

Olympus Bronchovideoscope, Models BF-P190 & BF-XP190.

Olympus Corporation of the Americas

FDA Devices Moderate Sep 6, 2023

Olympus Airway Mobilescope, Models MAF-DM2, MAF-GM2, & MAF-TM2.

Olympus Corporation of the Americas

FDA Devices Moderate Sep 6, 2023

Olympus Bronchovideoscope, Models BF-UC180F & BF-UC190F.

Olympus Corporation of the Americas

FDA Devices Moderate Sep 6, 2023

PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS

Edwards Lifesciences, LLC

FDA Devices Moderate Sep 6, 2023

Visera Hysterovideoscope Olympus HYF Type V

Olympus Corporation of the Americas

FDA Devices Moderate Sep 6, 2023

Waldemar Link GmbH & Co. KG (Mfg Site)

FDA Devices Moderate Sep 6, 2023

Atellica CH Total Bilirubin_2 -In vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma (lithium heparin) of adults and neonates Test Code: TBil_2 Siemens Material Number (SMN): 11097531

Siemens Healthcare Diagnostics, Inc.

FDA Devices Critical Sep 6, 2023

Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85

Datascope Corp.

FDA Devices Critical Sep 6, 2023

Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85

Datascope Corp.

FDA Devices Moderate Sep 6, 2023

SurgiCount+ Software Application-indicated as an adjunctive technology for augmenting the manual process of counting, displaying and recording the number of RFID-tagged absorbent articles used during surgical procedures Product Code: 0694-002-090;

Stryker Corporation

FDA Devices Moderate Sep 6, 2023

Olympus Tracheal Intubation Fiberscope, Models LF-DP, LF-GP, & LF-TP.

Olympus Corporation of the Americas

FDA Devices Moderate Sep 6, 2023

Olympus Bronchovideoscope, Model BF-Q180-AC

Olympus Corporation of the Americas

FDA Devices Moderate Sep 6, 2023

Olympus Bronchovideoscope, Models BF-MP190F.

Olympus Corporation of the Americas

FDA Devices Moderate Sep 6, 2023

EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V

Olympus Corporation of the Americas

FDA Devices Moderate Sep 6, 2023

LIF AMP, Adjustable Awl, REF 117-165, Part of the AMP System. Used with Spine Lateral Interbody Systems, IdentiTi LIF, Transcend LIF and Battalion LLIF,

Alphatec Spine, Inc.

FDA Devices Moderate Sep 6, 2023

Oculus Myopia Master , Ref 68100, CE 0123

Oculus Optikgeraete GMBH

FDA Devices Moderate Sep 6, 2023

Wireless Foot Switch distributed with Philips Allura Xper and Azurion Interventional Fluoroscopic X-Ray Systems

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

FDA Devices Moderate Sep 6, 2023

Atellica CH LDL Cholesterol- In vitro diagnostic use in the quantitative determination of LDL cholesterol in human serum and plasma (lithium heparin, EDTA, sodium heparin Test Code: LDLC Siemens Material Number (SMN): 11537214

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Sep 6, 2023

PHOROPTOR VRX DIGITAL REFRACTION SYSTEM-Digital refractor intended for the subjective measurement of the refractive error of the eye. MODEL NUMBER: 16242 [Model 16241 is the base model. Model 16242 includes an additional prism feature used for the measurement of ocular deviation in patients with latent or manifest strabismus].

Reichert, Inc.

FDA Devices Moderate Sep 6, 2023

Atellica CH Triglycerides_2: in vitro diagnostic use in the quantitative determination of triglycerides in human serum and plasma (lithium heparin, sodium heparin, potassium EDTA) using the Atellica CH Analyzer. SMN: 11537222

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Sep 6, 2023

The Chevalier Valvulotome is a device used to disrupt the valves of veins which are to be used as grafts in the in situ or non-reversed bypass procedure. The Chevalier Valvulotome consists of a 70 cm stainless steel shaft with two tips: 1) the cutting tip is shaped like an inverted tulip with four teeth at its base. This tip is designed to cut the vein valve cusps. 2) the other tip is atraumatic and used to test the patency and the course of the vein before the valvulotomy. The Chevalier Valv

LeMaitre Vascular, Inc.

FDA Devices Moderate Sep 6, 2023

Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85

Datascope Corp.

FDA Devices Moderate Sep 6, 2023

GS70 Salus Surgical Table, Product Code 18-070-70

Skytron, LLC

FDA Devices Critical Sep 6, 2023

Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85, 0998-UC-0800-75, 0998-UC-0800-83, 0998-UC-0800-85,

Datascope Corp.

FDA Devices Moderate Sep 6, 2023

Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x 14 mL R1, 4 x 11 mL R2

Beckman Coulter Inc.

FDA Devices Moderate Sep 6, 2023

epoc BGEM Test Card (BUN & TCO2),Veterinary with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1

Siemens Healthcare Diagnostics Inc

FDA Devices Critical Sep 6, 2023

Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85

Datascope Corp.

FDA Devices Moderate Sep 6, 2023

Oculus Pentacam AXL Wave, Ref 70020, CE 0123

Oculus Optikgeraete GMBH

FDA Devices Moderate Sep 6, 2023

Olympus Bronchovideoscope, Models BF-1TH190, BF-H190, BF-Q170, & BF-Q190.

Olympus Corporation of the Americas

FDA Devices Moderate Sep 6, 2023

Olympus Bronchovideoscope, Models BF-1T180, BF-1TQ180, BF-P180, & BF-Q180.

Olympus Corporation of the Americas

FDA Devices Moderate Sep 6, 2023

Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System.

Accuray Incorporated

FDA Devices Moderate Sep 6, 2023

Olympus Bronchovideoscope, Models BF-XT190.

Olympus Corporation of the Americas

FDA Devices Moderate Sep 6, 2023

epoc BGEM BUN Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1

Siemens Healthcare Diagnostics Inc

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.