PlainRecalls

2023 Recalls

5,513 recalls · Page 10 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 11 critical, 35 moderate, and 4 lower-severity recalls. The page references 15 distinct recalling firms operating in 4 distinct product categories, with 50 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (33), FDA Drug (17), 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 Low Nov 29, 2023

Lisinopril Tablets USP 20 mg, packaged in a) 15-count blister card (NDC 0615-7718-05), b) 30-count blister card (NDC 0615-8255-39), Rx only, Mfd By L…

NCS Healthcare of Kentucky Inc

FDA Drug Critical Nov 29, 2023

LEADER brand Dry Eye Relief (Polyethylene Glycol 400, 0.4% Propylene Glycol, 0.3%); 0.33 FL OZ (10 mL) dropper bottle, Sterile, Distributed By Cardin…

Cardinal Health Inc.

FDA Drug Critical Nov 29, 2023

LEADER brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline Hydrochloride 0.05%), 0.5 FL OZ (15 mL) dropper bottles, …

Cardinal Health Inc.

FDA Drug Moderate Nov 29, 2023

Integrity Biochem HSC 70-VA, Alcohol Antiseptic 70%, Hand Sanitizer, Vanilla Scented Topical Gel 208.19L (55 gallons)- drum. Integrity Biochem, 1100…

Integrity Bio-Chemicals LLC

FDA Drug Critical Nov 29, 2023

8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), a) 20x50 mL Single Dose Vials (Vial NDC 51754-5001-1; Carton NDC 51754-5001-5) and b)…

Exela Pharma Sciences LLC

FDA Drug Low Nov 29, 2023

Buspirone Hydrochloride Tabs USP 10 mg, packaged in a) 15-count blister card (NDC 0615-7718-05) b) 30-count blister card (NDC 0615-7718-39), Rx only,…

NCS Healthcare of Kentucky Inc

FDA Drug Critical Nov 29, 2023

LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 2 bottles, 0.5 FL OZ (15 mL) dropper bottles, Sterile, Distributed By Cardina…

Cardinal Health Inc.

FDA Drug Moderate Nov 29, 2023

Integrity Biochem HSC 70-LM, Alcohol Antiseptic 70%, Hand Sanitizer, Lemon Scented Topical Gel, 208.19 L (55 gallons) drum, Integrity Biochem, 1100 N…

Integrity Bio-Chemicals LLC

FDA Drug Critical Nov 29, 2023

Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Dist. by: RUGBY LABORATORIES, Livonia, MI 48152, NDC 0536-1325-94.

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

FDA Drug Moderate Nov 29, 2023

Tiglutik (riluzole) Oral Suspension 50 mg/10 mL (5 mg/mL), 600 mL (two bottles/300 mL each), RX only, Manufactured for ITF Pharma, Inc., Berwyn, PA 1…

ITF PHARMA INC

FDA Drug Moderate Nov 29, 2023

Integrity Biochem HSC70-LV, Alcohol Antiseptic 70%, Hand Sanitizer, Lavender Scented Topical Gel 208.19L (55 gallons) drum, Integrity Biochem, 1100 N…

Integrity Bio-Chemicals LLC

FDA Drug Critical Nov 29, 2023

LEADER brand Dry Eye Relief (Carboxymethylcellulose Sodium, 1%); 0.5 FL OZ (15 mL) dropper bottle, Sterile, Distributed By Cardinal Health, Dublin, O…

Cardinal Health Inc.

FDA Drug Low Nov 29, 2023

Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Packaged as (a) 30-count bottle, NDC 68462-390-30; (b) 1000-count Bottle, NDC 68462-390-10…

Glenmark Pharmaceuticals Inc., USA

FDA Drug Critical Nov 29, 2023

LEADER brand Lubricant Eye Drops (Propylene Glycol, 0.6%); 0.33 FL OZ (10 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio…

Cardinal Health Inc.

FDA Drug Critical Nov 29, 2023

LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 0.5 FL OZ (15 mL) dropper bottles, Sterile, Distributed By Cardinal Health, D…

Cardinal Health Inc.

FDA Drug Critical Nov 29, 2023

Lubricating Tears Eye Drops (Dextran/Hypromellose), 0.1%/0.3%, packaged in 0.5 FL OZ (15mL) bottles, Distributed by: RUGBY LABORATORIES, Livonia, MI …

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

FDA Drug Critical Nov 29, 2023

Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL (1mg/mL), 100 mL Single-Dose Vial, 25 count carton, Ready to Use For Intravenous Infusion O…

Exela Pharma Sciences LLC

FDA Devices Moderate Nov 29, 2023

Compress Device Short Anchor Plug, 26 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Numb…

Biomet, Inc.

FDA Devices Moderate Nov 29, 2023

Compress Device Short Anchor Plug, 24 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Numb…

Biomet, Inc.

FDA Devices Moderate Nov 29, 2023

Compress Device Short Anchor Plug, 14 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Numb…

Biomet, Inc.

FDA Devices Critical Nov 29, 2023

VariSoft infusion set, Model Number 1002828

Unomedical A/S

FDA Devices Moderate Nov 29, 2023

stryker Sage PrimaFit External Urine Management System for the Female Anatomy

Sage Products Inc

FDA Devices Moderate Nov 29, 2023

Signmoidovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum and sigmoid colon). Model Numb…

Aizu Olympus Co., Ltd.

FDA Devices Moderate Nov 29, 2023

Tracheal fiberscope-airway management, which includes observation to access airway anatomy, endotracheal/endobronchial intubation and management. M…

Aizu Olympus Co., Ltd.

FDA Devices Moderate Nov 29, 2023

Compress Device Short Anchor Plug, 28 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Numb…

Biomet, Inc.

FDA Devices Moderate Nov 29, 2023

Medline manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Adult Resuscitator REF #s: CPRM1116FPM, …

SunMed Holdings, LLC

FDA Devices Moderate Nov 29, 2023

GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507, 00024315007, 00024330007, 00024345007, 00024360007

Instrumentation Laboratory

FDA Devices Moderate Nov 29, 2023

Ventlab, LLC AirFlow manual resuscitator devices with integrated manometer, multiple accessory configurations to include: 1. AirFlow Adult Resusc…

SunMed Holdings, LLC

FDA Devices Moderate Nov 29, 2023

Gastroscope-endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) and for endoscopic surgery within the upper digestive tract. Model Numb…

Aizu Olympus Co., Ltd.

FDA Devices Moderate Nov 29, 2023

EXALT Model D Single-Use Duodenoscope: Outer box UPN# M00542420 & Outer box UPN# M0054242CE0.

Boston Scientific Corporation

FDA Devices Moderate Nov 29, 2023

Compress Device Segmental Anchor Plug, 18 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item …

Biomet, Inc.

FDA Devices Moderate Nov 29, 2023

Compress Device Segmental Anchor Plug, 20 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item …

Biomet, Inc.

FDA Devices Low Nov 29, 2023

Choleodochoscope. Model Numbers: CHF-BP30, CHF-CB30L, CHF-P60.

Aizu Olympus Co., Ltd.

FDA Devices Moderate Nov 29, 2023

Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130069X6

Medtronic Inc

FDA Devices Moderate Nov 29, 2023

Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ…

Aizu Olympus Co., Ltd.

FDA Devices Moderate Nov 29, 2023

Rhinolaryngoscope-for endoscopic diagnosis and treatment within the nasal lumens and airway anatomy (including nasopharyngeal and trachea). Model …

Aizu Olympus Co., Ltd.

FDA Devices Moderate Nov 29, 2023

Compress Device Short Anchor Plug, 12 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Numb…

Biomet, Inc.

FDA Devices Moderate Nov 29, 2023

Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130068X5

Medtronic Inc

FDA Devices Moderate Nov 29, 2023

Colonoscope-indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve). Model Number…

Aizu Olympus Co., Ltd.

FDA Devices Moderate Nov 29, 2023

Ventlab, LLC BreathTech manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. BreathTech Adult Resuscit…

SunMed Holdings, LLC

FDA Devices Moderate Nov 29, 2023

GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330004, 00024345004

Instrumentation Laboratory

FDA Devices Moderate Nov 29, 2023

Compress Device Segmental Anchor Plug, 14 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item …

Biomet, Inc.

FDA Devices Moderate Nov 29, 2023

EXALT Model D Single-Use Duodenoscope, 2 pack: Outer box UPN# M00542421, Inner box UPN # M00542420 & Outer box UPN# M0054242CE1, Inner box UPN # M005…

Boston Scientific Corporation

FDA Devices Moderate Nov 29, 2023

Compress Device Segmental Anchor Plug, 10 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item …

Biomet, Inc.

FDA Devices Moderate Nov 29, 2023

Bronchoscope - Ultrasonic: endoscopic real-time ultrasonic imaging, ultrasound guided needle aspiration and other endoscopic procedures within the ai…

Aizu Olympus Co., Ltd.

FDA Devices Moderate Nov 29, 2023

Ureteralscope- for endoscopic diagnosis and treatment within the ureter, kidney and biliary tract (common bile duct and hepatic duct). Model Numbers…

Aizu Olympus Co., Ltd.

FDA Devices Moderate Nov 29, 2023

Ventlab, LLC STAT-Check manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. STAT-Check Adult Resusci…

SunMed Holdings, LLC

FDA Devices Moderate Nov 29, 2023

Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MUS0130069X6

Medtronic Inc

FDA Devices Moderate Nov 29, 2023

Ventlab, LLC SafeSpot manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. SafeSpot Infant Resuscitato…

SunMed Holdings, LLC

FDA Devices Moderate Nov 29, 2023

Transnasal esophagovideoscope-For endoscopy and endoscopic surgery within the esophagus and stomach. Model Number: PEF-V.

Aizu Olympus Co., Ltd.

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