PlainRecalls

2023 Recalls

5,513 recalls · Page 18 of 111

2023 Recall Year Insight

Federal agencies issued 5,513 product recalls indexed by PlainRecalls in calendar year 2023. That represents about 6.57% of the 83,949 total recalls we track from 1995 through the present, and averages roughly 15.1 recalls per day across the FDA, CPSC, NHTSA, and USDA FSIS 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 111 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 8 critical, 39 moderate, and 3 lower-severity recalls. The page references 18 distinct recalling firms operating in 3 distinct product categories, with 50 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (44), FDA Drug (6), 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, NHTSA, or USDA FSIS for the system-of-record on any specific recall. PlainRecalls indexes this archive for research and consumer awareness purposes.

FDA Drug Critical Nov 1, 2023

ION*Sinus Spray, 1 fl oz/ 30 mL, Manufactured by: ION* Biome Charlottesville, VA

Biomic Sciences, LLC dba ION Intelligence of Nature

FDA Drug Low Nov 1, 2023

VANCOmycin HCI PF, 1.5 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, N…

Denver Solutions, LLC DBA Leiters Health

FDA Drug Moderate Nov 1, 2023

Restore Sinus Spray, Manufactured by: Biomic Sciences, LLC Charlottesville, VA

Biomic Sciences, LLC dba ION Intelligence of Nature

FDA Drug Low Nov 1, 2023

Oxytocin synthetic, 30 Units added to 0.9% Sodium Chloride 500mL IV Bag (0.06 Units per mL), Rx only, Leiter Compounding Health, 13796 Compark Blvd, …

Denver Solutions, LLC DBA Leiters Health

FDA Drug Moderate Nov 1, 2023

ION* Sinus Support Nasal Spray, 1 fl oz/30 ml bottles, Manufactured by: ION* Intelligence of Nature Charlottesville, VA

Biomic Sciences, LLC dba ION Intelligence of Nature

FDA Drug Low Nov 1, 2023

Methotrexate Tablets, USP, 2.5 mg, 10x10 Unit-Dose Tablets per carton, Rx only, Distributed by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724.…

West-Ward Columbus Inc

FDA Devices Moderate Nov 1, 2023

Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix

Medtronic Sofamor Danek USA Inc

FDA Devices Critical Nov 1, 2023

Monoject 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack

Cardinal Health 200, LLC

FDA Devices Moderate Nov 1, 2023

Centricity PACS-IW with Universal Viewer, versions 5.0 SPx with PACS-IW foundation; Radiological Image Processing System

GE Healthcare

FDA Devices Moderate Nov 1, 2023

LAVH, REF BBLV21C

American Contract Systems, Inc.

FDA Devices Moderate Nov 1, 2023

DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test REF 555-10

Universal Meditech Inc.

FDA Devices Moderate Nov 1, 2023

Robotics Pack SAH, REF SAR530M

American Contract Systems, Inc.

FDA Devices Moderate Nov 1, 2023

Robotics Pack, REF SJVO56B

American Contract Systems, Inc.

FDA Devices Critical Nov 1, 2023

Monoject 20 mL Syringe Luer-Lock Tip Soft Pack

Cardinal Health 200, LLC

FDA Devices Moderate Nov 1, 2023

PrestiBio Rapid Detection Pregnancy Test Midstream REF 100-17 3 TESTS

Universal Meditech Inc.

FDA Devices Moderate Nov 1, 2023

SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO

SynCardia Systems LLC

FDA Devices Moderate Nov 1, 2023

Grafton DMB Matrix, Model Numbers: a) T42200, b) T42210; Demineralized Bone Matrix

Medtronic Sofamor Danek USA Inc

FDA Devices Moderate Nov 1, 2023

PrestiBio URINALASYS TEST STRIP 10 PARAMETERS REF 900-10

Universal Meditech Inc.

FDA Devices Moderate Nov 1, 2023

Omega Medical Imaging Elevating Monitor Suspension, Part Number 1000-0085

Omega Medical Imaging, Inc.

FDA Devices Moderate Nov 1, 2023

Grafton DBM Orthoblend, Model Numbers: a) T44125INT, b) T44135, c) T44145, d) T44150; Demineralized Bone Matrix

Medtronic Sofamor Danek USA Inc

FDA Devices Critical Nov 1, 2023

8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System

B. Braun Medical, Inc.

FDA Devices Moderate Nov 1, 2023

DiagnosUS Pregnancy Test Midstream REF 100-17

Universal Meditech Inc.

FDA Devices Moderate Nov 1, 2023

Universal Viewer Workflow Manager, Image processing radiological system

GE Healthcare

FDA Devices Moderate Nov 1, 2023

Grafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010; Demineralized Bone Matrix

Medtronic Sofamor Danek USA Inc

FDA Devices Moderate Nov 1, 2023

Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures through a sternotomy incision approach. …

Maquet Cardiovascular, LLC

FDA Devices Moderate Nov 1, 2023

PrestiBio KETONE TEST STRIPS REF 900-1KET 100 STRIPS/+50 FREE

Universal Meditech Inc.

FDA Devices Moderate Nov 1, 2023

Vasc. Open CVOR SJH, REF SJVO56B

American Contract Systems, Inc.

FDA Devices Moderate Nov 1, 2023

Grafton DBM Putty, Model Numbers: a) T43102, b) T43102INT, c) T43103INT, d) T43105, e) T43105INT, f) T43110, g) T43110INT; Demineralized Bone Matrix

Medtronic Sofamor Danek USA Inc

FDA Devices Critical Nov 1, 2023

Astral 100 and Astral 150 ventilators

ResMed Ltd.

FDA Devices Critical Nov 1, 2023

8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK; Volumetric Infusion Pump System

B. Braun Medical, Inc.

FDA Devices Moderate Nov 1, 2023

Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1

Smiths Medical ASD Inc.

FDA Devices Moderate Nov 1, 2023

TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005

Acclarent, Inc.

FDA Devices Moderate Nov 1, 2023

Lem Fertility hCG Pregnancy Urine Test REF 100-12

Universal Meditech Inc.

FDA Devices Moderate Nov 1, 2023

DeTec hCG Pregnancy Urine Test Cassette Format, REG Cat: 100-13

Universal Meditech Inc.

FDA Devices Moderate Nov 1, 2023

Centricity Universal Viewer, software versions 6.0 SP0 through 6.0 SP7.1; Radiological Image Processing System

GE Healthcare

FDA Devices Moderate Nov 1, 2023

SOZO Bilateral Arm L-Dex Software

Impedimed Limited

FDA Devices Moderate Nov 1, 2023

OMTMO One Step Ovulation (LH) Test Strips REF 200-07

Universal Meditech Inc.

FDA Devices Critical Nov 1, 2023

Monoject" 60 mL Syringe Luer-Lock Tip Soft Pack

Cardinal Health 200, LLC

FDA Devices Moderate Nov 1, 2023

One Step Pregnancy Test REF 100-01

Universal Meditech Inc.

FDA Devices Moderate Nov 1, 2023

HealthyWiser UriTest" 10 Parameter Reagent Test Strips for Urinalysis REF 900-10

Universal Meditech Inc.

FDA Devices Moderate Nov 1, 2023

CVS PCSU SJH, REF SJCV48J

American Contract Systems, Inc.

FDA Devices Moderate Nov 1, 2023

Pediatric Heart SJH, REF SJPH34K

American Contract Systems, Inc.

FDA Devices Critical Nov 1, 2023

Monoject" 12 mL Syringe Luer-Lock Tip Soft Pack

Cardinal Health 200, LLC

FDA Devices Moderate Nov 1, 2023

OPMI LUMERA 300, REF 6137

Carl Zeiss Suzhou Co., Ltd.

FDA Devices Moderate Nov 1, 2023

PrestiBio Ovulation Strips REF 200-4 60 LH Test Strips

Universal Meditech Inc.

FDA Devices Moderate Nov 1, 2023

JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis

Smith & Nephew, Inc.

FDA Devices Moderate Nov 1, 2023

Cath Cardiac Pack, REF IHCC03V

American Contract Systems, Inc.

FDA Devices Moderate Nov 1, 2023

DiagnosUS¿ One Step FSH Menopausal Test (Strip) REF 210-07

Universal Meditech Inc.

FDA Devices Moderate Nov 1, 2023

PrestiBio Ovulation and Pregnancy Strips REF 100-4 and REF 200-4 60 LH Test Strips/+30 HCF Test Strips

Universal Meditech Inc.

FDA Devices Moderate Nov 1, 2023

DiagnosUS hCG Pregnancy Urine Test Cassette Format REF 100-13

Universal Meditech 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: CPSC + NHTSA + USDA FSIS — consumer product, vehicle, and meat/poultry recall feeds for 2023