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.
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
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
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
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.
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
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
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
EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
Staar Surgical Company
Integra Cranial Access Kit - For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7040
Integra LifeSciences Corp.
ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
Elekta, Inc.
ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
Elekta, Inc.
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-4X3, Order Number G22654; used to dilate strictures of the biliary tree
Wilson-Cook Medical Inc.
Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect …
CooperSurgical, Inc.
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3, Order Number G22655; used to dilate strictures of the biliary tree
Wilson-Cook Medical Inc.
ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
Elekta, Inc.
EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
Staar Surgical Company
Stay Safe Cap
Fresenius Medical Care Holdings, Inc.
EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
Staar Surgical Company
DRX Revolution Mobile X-Ray System
Carestream Health, Inc.
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.
Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN, OASIS BRU W/AC, 3650 ATS BLOOD RECOVERY
Atrium Medical Corporation
ProCuity bed series, model number 3009, item number: 3009PX-LE-400.
Stryker Medical Division of Stryker Corporation
CardioQuip Modular Cooler-Heater, Model:MCH-1000(i), Power: 115V-60hz,16A
CardioQuip, LLC
Monarch Platform REF MON-000006 100-240V- 50/60Hz 1440w
AURIS HEALTH INC
vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)
Vyaire Medical
Cooper Surgical H/S ELLIPTOSPHERE CATH 5 FR Set-For administering contrast media during Hysterosalpingography or Hysterosonography procedures to dete…
CooperSurgical, Inc.
ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
Elekta, Inc.
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3-E, Order Number G22766; used to dilate strictures of the biliary tree
Wilson-Cook Medical Inc.
PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103
Heartware, Inc.
Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3600-100, DRAIN, OASIS SINGLE W/AC, 3600 SINGLE COLLECTION.
Atrium Medical Corporation
Infusomat Administration Sets as listed below: 362031 Infusomat Space Pump Set with Caresite Injection Site; 362032 15 drops/mL, priming …
B. Braun Medical, Inc.
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
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order Number G22657; used to dilate strictures of the biliary tree
Wilson-Cook Medical Inc.
Multi-Mode Stimulator, Transcutaneous Electrical Nerve Stimulation
Liberty Medical Solutions, LLC
Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.
Atrium Medical Corporation
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
CooperSurgical H/S CATHETER SET FR 5 with Integated Stylet Model: 61-4005S For administering contrast media during Hysterosalpingography or Hystero…
CooperSurgical, Inc.
HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205
Heartware, Inc.
PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP
Heartware, Inc.
Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1.
Abiomed, Inc.
ProCuity bed series, model number 3009, item number: 3009PX-L-100.
Stryker Medical Division of Stryker Corporation
ProCuity bed series, model number 3009, item number: 3009PX-ZM-450.
Stryker Medical Division of Stryker Corporation
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3, Order Number G22656; used to dilate strictures of the biliary tree
Wilson-Cook Medical Inc.
CardioQuip Modular Cooler-Heater, Model:MCH-1000(m), Power: 115V-60hz,16A
CardioQuip, LLC
ProCurity bed series, model number 3009, item number: 3009PX-ZMX-600.
Stryker Medical Division of Stryker Corporation
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
Elekta, Inc.
NovoTHOR Gen 2.5 Regular whole body red light therapy bed, model S2183
Thor Photomedicine Ltd
Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: HITHSP04
Integra LifeSciences Corp.
ProCuity bed series, model number 3009, item number: 3009PX-LEX-400.
Stryker Medical Division of Stryker Corporation
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.
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.