PlainRecalls

2023 Recalls

Compiled from official public sources by the editorial team.

6,617 recalls · Page 25 of 133

2023 Recall Year Insight

Federal agencies issued 6,617 product recalls indexed by PlainRecalls in calendar year 2023. That represents about 6.51% of the 101,704 total recalls we track from 1995 through the present, and averages roughly 18.1 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 133 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 13 critical, 37 moderate, and 0 lower-severity recalls. The page references 19 distinct recalling firms operating in 3 distinct product categories, with 48 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (47), NHTSA (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 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, or NHTSA for the system-of-record on any specific recall. PlainRecalls indexes this archive for research and consumer awareness purposes.

FDA Drug Critical Oct 18, 2023

BREXAFEMME (Ibrexafungerp) tablets 150 mg, 4 count cartons, Rx Only, Manufactured for and distributed by SCYNEXIS, Inc., Jersey City, NJ 07302 NDC 7…

Scynexis, Inc.

FDA Devices Moderate Oct 18, 2023

Procedure pack: Presource PBDS Cat. PLMHCSBHF, Hermann Hospital MHHS, Kit, C Section B MHHS, Sterile.

Cardinal Health 200, LLC

FDA Devices Moderate Oct 18, 2023

Multichem P, Part Code 08P90-10

TECHNO-PATH MANUFACTURING LTD.

FDA Devices Moderate Oct 18, 2023

MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1

Mazor Robotics Ltd

FDA Devices Moderate Oct 18, 2023

Procedure pack: Presource PBDS, Cat. PEMHEEESR, Southeast Hospital MHHS, Kit, ENT, SE, Sterile.

Cardinal Health 200, LLC

FDA Devices Critical Oct 18, 2023

2008T HD SYS. W/O CDX BLUESTAR

Fresenius Medical Care Holdings, Inc.

FDA Devices Moderate Oct 18, 2023

REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, REF: 506-03-130

Encore Medical, LP

FDA Devices Moderate Oct 18, 2023

Constellation Vision System, REF: 8065751150

Alcon Research, LLC

FDA Devices Critical Oct 18, 2023

2008T Hemodialysis SYS, with CDX

Fresenius Medical Care Holdings, Inc.

FDA Devices Moderate Oct 18, 2023

CellQuicken Analyzer (Smart-Watch and Software), RoyalVibe Ultrasound Generator, Brainvibe, Envirovibe Water Restructuring Pad, RoyalVibe Therapy…

RoyalVibe Health Ltd.

FDA Devices Moderate Oct 18, 2023

NOVAPLUS GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: V20685255 through V20685290

Ansell Healthcare Products LLC

FDA Devices Moderate Oct 18, 2023

THUNDERBEAT, 5MM, 35CM, Front-actuated Grip Type S. Model: TB-0535FCS Indicated for open, laparoscopic (including single-site surgery) general surg…

Olympus Corporation of the Americas

FDA Devices Moderate Oct 18, 2023

Medfusion Syringe Pump, Model 3500-500, v3, v4, v5, and v6

Smiths Medical ASD Inc.

FDA Devices Moderate Oct 18, 2023

Medfusion Syringe Pump, Model 3500-0600-XX: a) 0600-00; b) 0600-01; c) 0600-50; d) 0600-51; e) 0600-82; f) 0600-249; software versions…

Smiths Medical ASD Inc.

FDA Devices Critical Oct 18, 2023

3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per case

Fresenius Medical Care Holdings, Inc.

FDA Devices Critical Oct 18, 2023

10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

Fresenius Medical Care Holdings, Inc.

FDA Devices Moderate Oct 18, 2023

Medfusion Syringe Pump, Model 4000-XXXX-XX: a) 0100-50, b) 0100-249, c) 0101-50, d) 0101-51, e) 0101-78, f) 0101-249, g) 0105-51, h) 0…

Smiths Medical ASD Inc.

FDA Devices Moderate Oct 18, 2023

Procedure packs: (1) Presource Pain Tray, Catalog SBAHFPTAS2, Advanced Surgery Center SAR, Sterile. (2) Presource Block Tray, Catalog SNE37ANMO…

Cardinal Health 200, LLC

FDA Devices Moderate Oct 18, 2023

Procedure packs: (1) Presource PBDS Cat. PN33BPCR2, Kit, Back, Sterile; (2) Presource PBDS Cat. POCGANA11, Kit, ARN Anterior Hip, Sterile; (3) Preso…

Cardinal Health 200, LLC

FDA Devices Moderate Oct 18, 2023

Multichem S Plus, Part Codes: a) 08P88-10, b) 08P88-11, c) 08P88-12

TECHNO-PATH MANUFACTURING LTD.

FDA Devices Critical Oct 18, 2023

2008T HD SYS. W/O CDX W/BIBAG BLUESTAR

Fresenius Medical Care Holdings, Inc.

FDA Devices Moderate Oct 18, 2023

DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and below; invitro diagnostic

Beckman Coulter, Inc.

FDA Devices Moderate Oct 18, 2023

Medfusion Syringe Pump, Model 3500VX-500, v3, v4, v5, and v6

Smiths Medical ASD Inc.

FDA Devices Moderate Oct 18, 2023

MED-810A Zemits NDPrime Laser products

Advance-Esthetic LLC

FDA Devices Moderate Oct 18, 2023

3T Heater Cooler System, REF: 16-02-85

LivaNova Deutschland GmbH

FDA Devices Moderate Oct 18, 2023

Access Thyroglobulin Calibrators

Beckman Coulter, Inc.

FDA Devices Moderate Oct 18, 2023

Coventus Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer-used to ream and subsequently open the intramedullary canal to the appropriate dep…

Flower Orthopedics Corporation

FDA Devices Moderate Oct 18, 2023

Procedure packs: (1) Presource PBDS, Cat. PGMHSUESR, Southeast Hospital MHHS, Kit, Set Up No Drape, SE, Sterile; (2) Presource PBDS Cat. PGVGLBP2…

Cardinal Health 200, LLC

FDA Devices Critical Oct 18, 2023

10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case

Fresenius Medical Care Holdings, Inc.

FDA Devices Moderate Oct 18, 2023

Presource Fistulogram Pack, Cat. SANOCFGHHA, Hartford Hospital, Sterile.

Cardinal Health 200, LLC

FDA Devices Moderate Oct 18, 2023

EMPOWR Acetabular System, Liner, 10¿ Hooded, HXe+, 40H, REF: 942-01-40H

Encore Medical, LP

FDA Devices Critical Oct 18, 2023

2008T Hemodialysis System w/Bibag

Fresenius Medical Care Holdings, Inc.

FDA Devices Critical Oct 18, 2023

2008T GEN 2 Bibag without CDX

Fresenius Medical Care Holdings, Inc.

FDA Devices Critical Oct 18, 2023

2008T HD SYS. CDX W/BIBAG BLUESTAR

Fresenius Medical Care Holdings, Inc.

FDA Devices Moderate Oct 18, 2023

EMPOWR 3D Knee Tibial Insert, 5R, 10MM, VE, REF: 342-10-705

Encore Medical, LP

FDA Devices Critical Oct 18, 2023

2008T Hemodialysis System without CDX

Fresenius Medical Care Holdings, Inc.

FDA Devices Moderate Oct 18, 2023

Multichem IA Plus, Part Codes: a) 08P86-10, b) 08P86-19

TECHNO-PATH MANUFACTURING LTD.

FDA Devices Moderate Oct 18, 2023

GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: 20685255 through 20685290

Ansell Healthcare Products LLC

FDA Devices Moderate Oct 18, 2023

Procedure packs: (1) Presource PBDS, Cat. PC71EXOU7, Ohio State Univ Wexner Med Ctr, Kit, Extraction Ross, Sterile; (2) Presource PBDS, Cat. PVOC…

Cardinal Health 200, LLC

FDA Devices Moderate Oct 18, 2023

THUNDERBEAT, 5MM, 45CM, Front-actuated Grip Type S Model: TB-0545FCS Indicated for open, laparoscopic (including single-site surgery) general surge…

Olympus Corporation of the Americas

FDA Devices Moderate Oct 18, 2023

Medfusion ASSEMBLY PLUNGER CASE LEFT 1/EA, Component Number G6001587, used on infusion pump

Smiths Medical ASD Inc.

FDA Devices Moderate Oct 18, 2023

Procedure packs: (1) Presource PBDS Cat. PNVMNIB21, Kit, Neuro IMAS, Sterile; (2) Presource PBDS Cat. PN08LAG13, Kit, Spine, Sterile; (3) Presou…

Cardinal Health 200, LLC

FDA Devices Moderate Oct 18, 2023

Procedure packs: (1) Presource Portacath Pack, Cat. SANV1PIFSB, Medstar Franklin Square Med CE, Sterile; and (2) Presource Bone Marrow Harvest Pa…

Cardinal Health 200, LLC

FDA Devices Moderate Oct 18, 2023

Medfusion PLUNGER FLOAT PLATE, Component Number G6000069, used on infusion pump

Smiths Medical ASD Inc.

FDA Devices Moderate Oct 18, 2023

BD BACTEC Plus Aerobic/F Culture Vials, Catalog Number 442023

Becton Dickinson & Co.

FDA Devices Moderate Oct 18, 2023

BD Pyxis CII Safe ES, REF: 1116-00; and BD Pyxis : CII Safe ES Desktop PC, Wired SCNR, REF: 107-254-01; CII Safe ES Desktop PC, W-LESS SCNR, BIO, REF…

CareFusion 303, Inc.

FDA Devices Moderate Oct 18, 2023

Procedure packs: (1) Presource PBDS Cat. PG33BTO21, Ohio State Univ Wexner Med Ctr, Kit, Roux UH, Sterile; (2) Presource PBDS Cat. PG33BTO22, Oh…

Cardinal Health 200, LLC

FDA Devices Critical Oct 18, 2023

2008T HD SYS. CDX BLUESTAR

Fresenius Medical Care Holdings, Inc.

NHTSA Critical Oct 18, 2023

BMW 2023-2024: ELECTRICAL SYSTEM:ADAS:DRIVER MONITORING:CAMERA/SENSOR

BMW

NHTSA Moderate Oct 17, 2023

ALFA ROMEO,DODGE 2023-2024: BACK OVER PREVENTION:WARNINGS:EXTERNAL/PEDESTRIAN ALERT

ALFA ROMEO,DODGE

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: CPSC + NHTSA - consumer product and vehicle recall feeds for 2023

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 2023 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.