PlainRecalls

2023 Recalls

5,513 recalls · Page 7 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 2 critical, 47 moderate, and 1 lower-severity recalls. The page references 25 distinct recalling firms operating in 2 distinct product categories, with 42 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (43), FDA Drug (7), 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 Dec 13, 2023

LET Gel (Lidocaine HCL/Epinephrine Bitartrate/Tetracaine HCL 4%/0.18%/0.5% Topical Gel), Single-use Topical Syringe, 3mL syringe, 10/pack, Rx only, C…

Right Value Drug Stores, LLC dba Carie Boyd's Prescription Shop

FDA Drug Moderate Dec 13, 2023

ceFAZolin sodium in Sterile Water for injection, Injectable Solution, 1g/10mL (0.1 g per mL), Syringe, Rx only, Wells Pharma, NDC 73702-131-10

Wells Pharma of Houston LLC

FDA Drug Moderate Dec 13, 2023

KinderMed INFANTS' PAIN & FEVER Acetaminophen, 160 mg per 5 mL bottles, Oral Suspension, Organic Cherry Flavor, 2 FL OZ (59 mL), Distributed By: Kind…

KINDER FARMS LLC

FDA Drug Moderate Dec 13, 2023

ROPivacaine HCl 0.2% PF in Sodium Chloride 1,000 mg/500 mL (2 mg per mL) Injection, 500 mL bags, Rx only, STAQ Pharma Inc. 14135 E 42nd Ave, Unit 50,…

STAQ Pharma, Inc.

FDA Drug Moderate Dec 13, 2023

Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL per vial, Rx only, Manufactured for: Baxter Healthcare Corporation, Deerfield, IL 60015 USA. M…

Baxter Healthcare Corporation

FDA Drug Critical Dec 13, 2023

SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM Huningue S.A.S., Huningue, Fra…

Novartis Pharmaceuticals Corporation

FDA Drug Moderate Dec 13, 2023

KinderMed KIDS' PAIN & FEVER Acetaminophen, 160 mg per 5 mL bottles, Oral Suspension, Organic Cherry Flavor, 4 FL OZ (118 mL), Distributed By: Kinder…

KINDER FARMS LLC

FDA Devices Moderate Dec 13, 2023

EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.

Staar Surgical Company

FDA Devices Moderate Dec 13, 2023

Integra Cranial Access Kit - For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7040

Integra LifeSciences Corp.

FDA Devices Moderate Dec 13, 2023

ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

Elekta, Inc.

FDA Devices Moderate Dec 13, 2023

ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

Elekta, Inc.

FDA Devices Moderate Dec 13, 2023

QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-4X3, Order Number G22654; used to dilate strictures of the biliary tree

Wilson-Cook Medical Inc.

FDA Devices Moderate Dec 13, 2023

Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect …

CooperSurgical, Inc.

FDA Devices Moderate Dec 13, 2023

QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3, Order Number G22655; used to dilate strictures of the biliary tree

Wilson-Cook Medical Inc.

FDA Devices Moderate Dec 13, 2023

ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

Elekta, Inc.

FDA Devices Moderate Dec 13, 2023

EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.

Staar Surgical Company

FDA Devices Moderate Dec 13, 2023

Stay Safe Cap

Fresenius Medical Care Holdings, Inc.

FDA Devices Moderate Dec 13, 2023

EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.

Staar Surgical Company

FDA Devices Moderate Dec 13, 2023

DRX Revolution Mobile X-Ray System

Carestream Health, Inc.

FDA Devices Moderate Dec 13, 2023

Integra Cranial access kit (without Prep solutions) Bit and Guard-For access to the subarachnoid space or the lateral ventricles of the brain. Catal…

Integra LifeSciences Corp.

FDA Devices Moderate Dec 13, 2023

Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN, OASIS BRU W/AC, 3650 ATS BLOOD RECOVERY

Atrium Medical Corporation

FDA Devices Moderate Dec 13, 2023

ProCuity bed series, model number 3009, item number: 3009PX-LE-400.

Stryker Medical Division of Stryker Corporation

FDA Devices Moderate Dec 13, 2023

CardioQuip Modular Cooler-Heater, Model:MCH-1000(i), Power: 115V-60hz,16A

CardioQuip, LLC

FDA Devices Moderate Dec 13, 2023

Monarch Platform REF MON-000006 100-240V- 50/60Hz 1440w

AURIS HEALTH INC

FDA Devices Moderate Dec 13, 2023

vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)

Vyaire Medical

FDA Devices Moderate Dec 13, 2023

Cooper Surgical H/S ELLIPTOSPHERE CATH 5 FR Set-For administering contrast media during Hysterosalpingography or Hysterosonography procedures to dete…

CooperSurgical, Inc.

FDA Devices Moderate Dec 13, 2023

ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

Elekta, Inc.

FDA Devices Moderate Dec 13, 2023

QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3-E, Order Number G22766; used to dilate strictures of the biliary tree

Wilson-Cook Medical Inc.

FDA Devices Moderate Dec 13, 2023

PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103

Heartware, Inc.

FDA Devices Moderate Dec 13, 2023

Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3600-100, DRAIN, OASIS SINGLE W/AC, 3600 SINGLE COLLECTION.

Atrium Medical Corporation

FDA Devices Critical Dec 13, 2023

Infusomat Administration Sets as listed below: 362031 Infusomat Space Pump Set with Caresite Injection Site; 362032 15 drops/mL, priming …

B. Braun Medical, Inc.

FDA Devices Moderate Dec 13, 2023

STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vitro diagnostic for blood ketone values.

Stanbio Laboratory, LP

FDA Devices Moderate Dec 13, 2023

QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order Number G22657; used to dilate strictures of the biliary tree

Wilson-Cook Medical Inc.

FDA Devices Moderate Dec 13, 2023

Multi-Mode Stimulator, Transcutaneous Electrical Nerve Stimulation

Liberty Medical Solutions, LLC

FDA Devices Moderate Dec 13, 2023

Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.

Atrium Medical Corporation

FDA Devices Moderate Dec 13, 2023

BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine Molecular Quality Controls, Inc (MMQCI) FilmArray BCID2 Con…

BioFire Diagnostics, LLC

FDA Devices Moderate Dec 13, 2023

CooperSurgical H/S CATHETER SET FR 5 with Integated Stylet Model: 61-4005S For administering contrast media during Hysterosalpingography or Hystero…

CooperSurgical, Inc.

FDA Devices Moderate Dec 13, 2023

HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205

Heartware, Inc.

FDA Devices Moderate Dec 13, 2023

PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP

Heartware, Inc.

FDA Devices Moderate Dec 13, 2023

Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1.

Abiomed, Inc.

FDA Devices Moderate Dec 13, 2023

ProCuity bed series, model number 3009, item number: 3009PX-L-100.

Stryker Medical Division of Stryker Corporation

FDA Devices Moderate Dec 13, 2023

ProCuity bed series, model number 3009, item number: 3009PX-ZM-450.

Stryker Medical Division of Stryker Corporation

FDA Devices Moderate Dec 13, 2023

QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3, Order Number G22656; used to dilate strictures of the biliary tree

Wilson-Cook Medical Inc.

FDA Devices Moderate Dec 13, 2023

CardioQuip Modular Cooler-Heater, Model:MCH-1000(m), Power: 115V-60hz,16A

CardioQuip, LLC

FDA Devices Moderate Dec 13, 2023

ProCurity bed series, model number 3009, item number: 3009PX-ZMX-600.

Stryker Medical Division of Stryker Corporation

FDA Devices Moderate Dec 13, 2023

ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

Elekta, Inc.

FDA Devices Moderate Dec 13, 2023

NovoTHOR Gen 2.5 Regular whole body red light therapy bed, model S2183

Thor Photomedicine Ltd

FDA Devices Moderate Dec 13, 2023

Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: HITHSP04

Integra LifeSciences Corp.

FDA Devices Moderate Dec 13, 2023

ProCuity bed series, model number 3009, item number: 3009PX-LEX-400.

Stryker Medical Division of Stryker Corporation

FDA Devices Moderate Dec 13, 2023

Monarch Platform REF MON-000005-01R, 100-240V- 50/60Hz 1440w

AURIS HEALTH 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