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.
ION*Sinus Spray, 1 fl oz/ 30 mL, Manufactured by: ION* Biome Charlottesville, VA
Biomic Sciences, LLC dba ION Intelligence of Nature
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
Restore Sinus Spray, Manufactured by: Biomic Sciences, LLC Charlottesville, VA
Biomic Sciences, LLC dba ION Intelligence of Nature
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
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
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
Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix
Medtronic Sofamor Danek USA Inc
Monoject 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack
Cardinal Health 200, LLC
Centricity PACS-IW with Universal Viewer, versions 5.0 SPx with PACS-IW foundation; Radiological Image Processing System
GE Healthcare
LAVH, REF BBLV21C
American Contract Systems, Inc.
DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test REF 555-10
Universal Meditech Inc.
Robotics Pack SAH, REF SAR530M
American Contract Systems, Inc.
Robotics Pack, REF SJVO56B
American Contract Systems, Inc.
Monoject 20 mL Syringe Luer-Lock Tip Soft Pack
Cardinal Health 200, LLC
PrestiBio Rapid Detection Pregnancy Test Midstream REF 100-17 3 TESTS
Universal Meditech Inc.
SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO
SynCardia Systems LLC
Grafton DMB Matrix, Model Numbers: a) T42200, b) T42210; Demineralized Bone Matrix
Medtronic Sofamor Danek USA Inc
PrestiBio URINALASYS TEST STRIP 10 PARAMETERS REF 900-10
Universal Meditech Inc.
Omega Medical Imaging Elevating Monitor Suspension, Part Number 1000-0085
Omega Medical Imaging, Inc.
Grafton DBM Orthoblend, Model Numbers: a) T44125INT, b) T44135, c) T44145, d) T44150; Demineralized Bone Matrix
Medtronic Sofamor Danek USA Inc
8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System
B. Braun Medical, Inc.
DiagnosUS Pregnancy Test Midstream REF 100-17
Universal Meditech Inc.
Universal Viewer Workflow Manager, Image processing radiological system
GE Healthcare
Grafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010; Demineralized Bone Matrix
Medtronic Sofamor Danek USA Inc
Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures through a sternotomy incision approach. …
Maquet Cardiovascular, LLC
PrestiBio KETONE TEST STRIPS REF 900-1KET 100 STRIPS/+50 FREE
Universal Meditech Inc.
Vasc. Open CVOR SJH, REF SJVO56B
American Contract Systems, Inc.
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
Astral 100 and Astral 150 ventilators
ResMed Ltd.
8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK; Volumetric Infusion Pump System
B. Braun Medical, Inc.
Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1
Smiths Medical ASD Inc.
TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005
Acclarent, Inc.
Lem Fertility hCG Pregnancy Urine Test REF 100-12
Universal Meditech Inc.
DeTec hCG Pregnancy Urine Test Cassette Format, REG Cat: 100-13
Universal Meditech Inc.
Centricity Universal Viewer, software versions 6.0 SP0 through 6.0 SP7.1; Radiological Image Processing System
GE Healthcare
SOZO Bilateral Arm L-Dex Software
Impedimed Limited
OMTMO One Step Ovulation (LH) Test Strips REF 200-07
Universal Meditech Inc.
Monoject" 60 mL Syringe Luer-Lock Tip Soft Pack
Cardinal Health 200, LLC
One Step Pregnancy Test REF 100-01
Universal Meditech Inc.
HealthyWiser UriTest" 10 Parameter Reagent Test Strips for Urinalysis REF 900-10
Universal Meditech Inc.
CVS PCSU SJH, REF SJCV48J
American Contract Systems, Inc.
Pediatric Heart SJH, REF SJPH34K
American Contract Systems, Inc.
Monoject" 12 mL Syringe Luer-Lock Tip Soft Pack
Cardinal Health 200, LLC
OPMI LUMERA 300, REF 6137
Carl Zeiss Suzhou Co., Ltd.
PrestiBio Ovulation Strips REF 200-4 60 LH Test Strips
Universal Meditech Inc.
JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis
Smith & Nephew, Inc.
Cath Cardiac Pack, REF IHCC03V
American Contract Systems, Inc.
DiagnosUS¿ One Step FSH Menopausal Test (Strip) REF 210-07
Universal Meditech Inc.
PrestiBio Ovulation and Pregnancy Strips REF 100-4 and REF 200-4 60 LH Test Strips/+30 HCF Test Strips
Universal Meditech Inc.
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.
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
Read our methodology — how this data is sourced, computed, and verified.