PlainRecalls

2023 Recalls

5,513 recalls · Page 45 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, 38 moderate, and 1 lower-severity recalls. The page references 12 distinct recalling firms operating in 2 distinct product categories, with 50 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (45), FDA Drug (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, 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 Moderate Jul 26, 2023

SUCCINYLcholine Chloride 200 mg/10mL (20 mg/mL), 10 mL BD Syringe, Rx Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801…

New England Life Care, Inc. dba Advanced Compounding Solutions

FDA Drug Low Jul 26, 2023

Loteprednol Etabonate Ophthalmic Suspension, 5 mg/mL (0.5%), packaged as one bottle in a carton in a) 10 mL bottle (NDC# 62756-232-55) and b) 15 mL b…

SUN PHARMACEUTICAL INDUSTRIES INC

FDA Drug Moderate Jul 26, 2023

Norepinephrine 8 mg per 250 mL (32 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case, Rx only, Ster…

SterRx, LLC

FDA Drug Moderate Jul 26, 2023

Norepinephrine 32 mg per 250 mL (128 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case, Rx only, St…

SterRx, LLC

FDA Drug Moderate Jul 26, 2023

PHENYLephrine HCl 10mg added to 0.9% Sodium Chloride 250mL, 250 mL IV Bag @60 Total volume), RX only, Advanced Compounding Solutions, 4 Constitution …

New England Life Care, Inc. dba Advanced Compounding Solutions

FDA Devices Moderate Jul 26, 2023

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CVC PACK, Model Number DYNJ46967F; b) ENDOVENOUS CORE…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Critical Jul 26, 2023

Olympus BRONCHOFIBERSCOPE BF Type, Model Numbers BF-PE2, BF-TE2

Olympus Corporation of the Americas

FDA Devices Moderate Jul 26, 2023

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FETAL SURGERY CDS-LF, Model Number CDS840214Q; b) MINOR P…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Critical Jul 26, 2023

Olympus EVIS EXERA III BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-H190, BF-Q190, BF-XT190, BF-1TH190

Olympus Corporation of the Americas

FDA Devices Moderate Jul 26, 2023

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a. NORTON CHILDRENS CATH LAB-LF, Model Number 00-401185Q; b.…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jul 26, 2023

Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software

Digisonics, Inc

FDA Devices Moderate Jul 26, 2023

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATHETERLESS INSERTION KIT, Model Number CVI4510; b) VA…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jul 26, 2023

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) TOTAL JOINT, Model Number CDS985555S; b) TOTAL KNEE, Mode…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jul 26, 2023

RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a c…

Cytocell Ltd.

FDA Devices Moderate Jul 26, 2023

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY PACK, Model Number DYNJ55252C; b) CATH LAB PAC…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jul 26, 2023

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: BREAST BIOPSY TRAY, Model Number SPEC0130C

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Critical Jul 26, 2023

Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800-34 0998-00-0800-…

Datascope Corp.

FDA Devices Critical Jul 26, 2023

Impella LD intravascular micro axial blood pump, Product Number 005082

Abiomed, Inc.

FDA Devices Moderate Jul 26, 2023

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY DRP PK PEDI CATH, Model Number 00-401318M; b)…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jul 26, 2023

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CVC INFANT INSERTION PACK, Model Number CVI4770A; b) INSE…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jul 26, 2023

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VANTEX CVC BNDL, 3L 7F 16CM W MICROCLAVE, Model Number ECVC1…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jul 26, 2023

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: KIT,SUCTION CATH,14FR W/WATER, Model Number DYND41472

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jul 26, 2023

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: ARTHROSCOPY PACK, Model Number DYNJ44322G

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jul 26, 2023

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) LACERATION TRAY, Model Number DYNDL1134A; b) ULTRASOUND…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Critical Jul 26, 2023

Impella 5.0 intravascular micro axial blood pump, Product Number 005062

Abiomed, Inc.

FDA Devices Moderate Jul 26, 2023

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) EP PACER PACK, Model Number DYNJ67770A; b) EP PROCEDURE PA…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jul 26, 2023

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: PROBE COVER PACK, Model Number DYNDA1219

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jul 26, 2023

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) RADIAL ARTERIAL LINE KIT, Model Number ART1070A; b) ARTER…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Critical Jul 26, 2023

Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85

Datascope Corp.

FDA Devices Moderate Jul 26, 2023

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VAD/PICC IV KIT, Model Number DYNDV2200; b) ULTRASOUND …

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Critical Jul 26, 2023

Olympus BRONCHOVIDEOSCOPE, Model Numbers BF-Q170

Olympus Corporation of the Americas

FDA Devices Critical Jul 26, 2023

Olympus EVIS EXERA BRONCHOVIDEOSCOPE BF TYPE, Model Number BF-XT160

Olympus Corporation of the Americas

FDA Devices Moderate Jul 26, 2023

GEM FLOW COUPLER Monitor, PN 5156-00000-011

Baxter Healthcare Corporation

FDA Devices Moderate Jul 26, 2023

Medline O.R. Scissors, S/B, Sterile, 5.5, Model #DYND04000

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jul 26, 2023

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: PACK ENDO AAA HYBRID CHRG, Model Number DYNJ60126B

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jul 26, 2023

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ARTERIAL LINE START KIT , Model Number ART920; b) ULTRASO…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jul 26, 2023

Aeris Balloon Dilation Catheter

Bryan Medical Inc

FDA Devices Moderate Jul 26, 2023

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: PEDIATRIC EP PACK, Model Number DYNJ45158A

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jul 26, 2023

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BLOCK PACK, Model Number DYNJ81722; b) PAIN BLOCK TRAY, M…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jul 26, 2023

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FEMORAL ARTERIAL LINE BUNDLE, Model Number ART1005; b) 20…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jul 26, 2023

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BREAST PACK, Model Number DYNDH1306; b) BRST BX TRAY, M…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jul 26, 2023

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ULTRASOUND PACK, Model Number DYNDH1112; b) PARA THORAC…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jul 26, 2023

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VNUS TRAY, Model Number DYNJ44410G; b) INTRAUTERINE TRNSF…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jul 26, 2023

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) MHC VASCULAR HYBRID PK-LF, Model Number DYNJ53433K; b) VEI…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Critical Jul 26, 2023

Impella CP with SmartAssist intravascular micro axial blood pump, Product Numbers 0048-0024, 0048-0045, 1000080

Abiomed, Inc.

FDA Devices Moderate Jul 26, 2023

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: STERILE SET FOR IMPLANT-LF, Model Number OST011F

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jul 26, 2023

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CRANIOTOMY CDS-1, Model Number CDS982889I; b) JOINT INJ…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Critical Jul 26, 2023

Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800-34 0998-00-0800-…

Datascope Corp.

FDA Devices Critical Jul 26, 2023

Olympus OES BRONCHOFIBERSCOPE BF Type, Model Numbers BF-XT40, BF-P60, BF-MP60, BF-1T60

Olympus Corporation of the Americas

FDA Devices Moderate Jul 26, 2023

Contour¿ next GEN Blood Glucose Monitoring System

Ascensia Diabetes Care US, 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