PlainRecalls

2023 Recalls

6,535 recalls · Page 95 of 131

2023 Recall Year Insight

Federal agencies issued 6,535 product recalls indexed by PlainRecalls in calendar year 2023. That represents about 7.78% of the 83,949 total recalls we track from 1995 through the present, and averages roughly 17.9 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 131 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 0 critical, 49 moderate, and 1 lower-severity recalls. The page references 26 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 (30), FDA Drug (15), FDA Food (5), 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 Food Low Apr 5, 2023

Rakkyo (scallions) distributed in un-labeled plastic containers 8oz and/or 12oz. Containers were then labeled at H-mart, G-mart, or M2M retail store.

Lemonland Food Corp

FDA Food Moderate Apr 5, 2023

Mary s Gone Crackers Super Seed Seaweed & Black Sesame Crackers Product Item number: 10033380101 UPC: 8 53665 00510 7

Mary's Gone Crackers

FDA Food Moderate Apr 5, 2023

Seasoned Hot Pepper Leaves distributed in un-labeled plastic containers 8oz. Containers were then labeled at H-mart, G-mart, or M2M retail store.

Lemonland Food Corp

FDA Food Moderate Apr 5, 2023

Stir-Fried Dried Squid distributed in un-labeled plastic containers 6oz., 8oz., and 12oz. Containers were then labeled at H-mart, G-mart, or M2M reta…

Lemonland Food Corp

FDA Food Moderate Apr 5, 2023

Spicy Cucumber Salad distributed in un-labeled plastic containers 8oz, 12oz. and 16oz. Containers were then labeled at H-mart, G-mart, or M2M retail…

Lemonland Food Corp

FDA Drug Moderate Apr 5, 2023

Glimepiride, USP, 1 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0723-30; b) 90-count bottle, NDC 61919-0723-90 Packaged and Dist…

Direct Rx

FDA Drug Moderate Apr 5, 2023

Simvastatin, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0710-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 305…

Direct Rx

FDA Drug Moderate Apr 5, 2023

Simvastatin, USP, 40 mg, Rx Only, Packaged as a 90-count bottle, NDC 61919-0431-90, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

Direct Rx

FDA Drug Moderate Apr 5, 2023

Calcitonin Salmon Nasal Spray, USP, 2200 International Units per mL corresponding to 200 International Units/spray, 3.7 mL bottle, Rx only, Manufactu…

Endo Pharmaceuticals, Inc.

FDA Drug Moderate Apr 5, 2023

Ropinirole, USP, 0.25 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30; Packaged and Distributed By: Direct Rx, Dawsonville, GA …

Direct Rx

FDA Drug Moderate Apr 5, 2023

Glimepiride, USP, 4 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0250-30; b) 90-count bottle, NDC 61919-0250-90 Packaged and Dist…

Direct Rx

FDA Drug Moderate Apr 5, 2023

Glimepiride, USP, 2 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0488-30; b) 90-count bottle, NDC 61919-0448-90 Packaged and Dist…

Direct Rx

FDA Drug Moderate Apr 5, 2023

Ropinirole, USP, 1 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30; Packaged and Distributed By: Direct Rx, Dawsonville, GA 305…

Direct Rx

FDA Drug Moderate Apr 5, 2023

Dabigatran Etexilate 150mg Capsules, 150 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascen…

Ascend Laboratories, LLC

FDA Drug Moderate Apr 5, 2023

Simvastatin, USP, 10 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0688-30 b) 90-count bottle, NDC61919-0688-90, Packaged and Dist…

Direct Rx

FDA Drug Moderate Apr 5, 2023

Finasteride, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0733-90; Packaged and Distributed By: Direct Rx

Direct Rx

FDA Drug Moderate Apr 5, 2023

Fentanyl 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (1mg/mL) added to 250mL 0.9% Sodium Chloride, For Epidural Use Only, Rx only, 3801 Mojave Ct. Sui…

Apollo Care

FDA Drug Moderate Apr 5, 2023

Montelukast Sodium Tablets, USP, 10 mg Tablets, Rx Only, Packaged as: a) 30-count bottle, NDC 61919-0009-30; b) 90-count bottle, NDC 61919-0009-90; P…

Direct Rx

FDA Drug Moderate Apr 5, 2023

Dabigatran Etexilate Capsules, 75 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Labora…

Ascend Laboratories, LLC

FDA Drug Moderate Apr 5, 2023

Simvastatin, USP, 20 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0446-30 b) 90-count bottle, NDC 61919-0446-90, Packaged and Dis…

Direct Rx

FDA Devices Moderate Apr 5, 2023

Instructions for Use for the following Leksell Stereotactic System and Leksell Neurosurgical Instruments: (1) Part #A2800-26, Backlund Catheter In…

Elekta Instrument AB

FDA Devices Moderate Apr 5, 2023

ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET table-A Fluoroscopic X-Ray system. Material # 10849000.

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Apr 5, 2023

ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Par…

Instrumentation Laboratory

FDA Devices Moderate Apr 5, 2023

PCRopsis Lysis Beads, IVDD: a) 25 tubes , REF 597000; b) 25 tubes, REF 597825; c) 50 tubes, REF 597850; d) 25 grams, REF 5970025; e) 1000 kilogram, R…

Entopsis , Inc.

FDA Devices Moderate Apr 5, 2023

ACL ELITE PRO-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number…

Instrumentation Laboratory

FDA Devices Moderate Apr 5, 2023

Neodent GM X 6mm Engaging Titanium Base, REF: 9007162

Preat Corp

FDA Devices Moderate Apr 5, 2023

PCRopsis Reagent RVD with RVD Enhancer: a) 1 mL, VALIDATION USE ONLY, REF 78336001; b) 25 mL, REF 78336025; c) 100 mL, REF 78336100; Extraction-fre…

Entopsis , Inc.

FDA Devices Moderate Apr 5, 2023

Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.

Baxter Healthcare Corporation

FDA Devices Moderate Apr 5, 2023

DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on victims of sudden cardiac arrest

Defibtech, LLC

FDA Devices Moderate Apr 5, 2023

PCRopsis BCSNano (1mL), REF 2276001; nucleic acid extraction from a variety of biological samples

Entopsis , Inc.

FDA Devices Moderate Apr 5, 2023

Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305

Fujifilm Irvine Scientific, Inc.

FDA Devices Moderate Apr 5, 2023

PCRopsis Support: a) 1 mL, REF 787001; b) 0.25 mL, REF 787002; c) 25 uL, REF 787003; Improves the functionality of PCRopsis regents for select appl…

Entopsis , Inc.

FDA Devices Moderate Apr 5, 2023

Alcon Custom Pak Surgical Procedure Pack: Pak Number & Pak Description: 17533-04 DR GROSS LPS LLC 18704-03 CATARACT SURGI CARE 18382-03 DR GEORGE…

Alcon Research, LLC

FDA Devices Moderate Apr 5, 2023

da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model IS4200

Intuitive Surgical, Inc.

FDA Devices Moderate Apr 5, 2023

Express Mini 500 Dry Seal Chest Drain, Part Number 16400

Atrium Medical Corporation

FDA Devices Moderate Apr 5, 2023

PCRopsis Reagent RVD-RT, IVD: a) 1 mL, REF 78378001; b) 25 mL, REF 78378025; c) 100 mL, REF 78378100; Extraction-free PCR at room temperature; nucl…

Entopsis , Inc.

FDA Devices Moderate Apr 5, 2023

MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor protein in human plasma or serum, Catalog Number A037, Containing …

Quidel Corporation

FDA Devices Moderate Apr 5, 2023

Color Cuff Single Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-135; Color Cuff Dual Port, Single Bladder 30 (Royal Blu…

Stryker Sustainability Solutions

FDA Devices Moderate Apr 5, 2023

ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0…

Instrumentation Laboratory

FDA Devices Moderate Apr 5, 2023

CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP concentration in serum Catalogue number: CP3826

Randox Laboratories

FDA Devices Moderate Apr 5, 2023

Iradimed Corporation MRidium MRI 1000 Series Infusion Sets, MRI Infusuui Set - Syringe Adapter Set, REF 1057-50,

Iradimed Corporation

FDA Devices Moderate Apr 5, 2023

CoCr Femoral Head, XS, 38/-8, Taper 12/14-Intended to be used as a modular head component for articulation in total hip arthroplasty. Item Number: 0…

Zimmer, Inc.

FDA Devices Moderate Apr 5, 2023

PCRopsis Activator: a) 1.5mL, REF 228001; b) 0.5mL,REF 228002; nucleic acid extraction from a variety of biological samples

Entopsis , Inc.

FDA Devices Moderate Apr 5, 2023

PCRopsis Reagent Buccal, IVD, REF 282001; Extraction-free PCR from bucca; swabs (no transport medium) ,nucleic acid extraction from a variety of biol…

Entopsis , Inc.

FDA Devices Moderate Apr 5, 2023

GaGa Pro Lighting Equipment Co. Ltd. manufactures Class IV Laser Light Show (LLS)projectors for the purposes of demonstration and entertainment.

GAGA PRO LIGHTING EQUIPMENT CO.,

FDA Devices Moderate Apr 5, 2023

Cirq Arm System 2.0

Brainlab AG

FDA Devices Moderate Apr 5, 2023

COVIDIEN Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed REF 86051 7.0 mm I.D. The Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed are indicated for …

Covidien

FDA Devices Moderate Apr 5, 2023

SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210

Limacorporate S.p.A

FDA Devices Moderate Apr 5, 2023

ACL ELITE PRO Refurbished)-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing.…

Instrumentation Laboratory

FDA Devices Moderate Apr 5, 2023

Atrium Pneumostat Chest Drain Valve, Part Number 16100

Atrium Medical Corporation

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