PlainRecalls

2023 Recalls

6,617 recalls · Page 33 of 133

2023 Recall Year Insight

Federal agencies issued 6,617 product recalls indexed by PlainRecalls in calendar year 2023. That represents about 6.51% of the 101,704 total recalls we track from 1995 through the present, and averages roughly 18.1 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 133 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 7 critical, 41 moderate, and 2 lower-severity recalls. The page references 25 distinct recalling firms operating in 3 distinct product categories, with 50 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (38), FDA Drug (12), 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 Drug Critical Sep 27, 2023

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

Novartis Pharmaceuticals Corp.

FDA Drug Moderate Sep 27, 2023

MAJOR LubriFresh P.M. Nighttime Ointment, Lubricant Eye Ointment, Sterile, 0.125 OZ (3.5g), Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 4…

AMMAN PHARMACEUTICAL INDUSTRIES

FDA Drug Moderate Sep 27, 2023

TRP Natural Eyes, Dryness Relief PF, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 15…

AMMAN PHARMACEUTICAL INDUSTRIES

FDA Drug Moderate Sep 27, 2023

TRP Natural Eyes, Twitching Relief, Sterile Eye Ointment, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., …

AMMAN PHARMACEUTICAL INDUSTRIES

FDA Drug Moderate Sep 27, 2023

TRP Natural Eyes, Dryness Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 …

AMMAN PHARMACEUTICAL INDUSTRIES

FDA Drug Moderate Sep 27, 2023

TRP Natural Eyes, Pink Eye Relief PF, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1…

AMMAN PHARMACEUTICAL INDUSTRIES

FDA Drug Moderate Sep 27, 2023

TRP Natural Eyes, Stye Relief, Sterile Eye Ointment, Homeopathic 0.14 oz (4 grams), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 D…

AMMAN PHARMACEUTICAL INDUSTRIES

FDA Drug Low Sep 27, 2023

Kroger Mint Burst ANTISEPTIC MOUTH RINSE ANTIGINGIVITIS/ANTIPLAQUE (Eucalyptol 0.092%, menthol 0.042%, Methyl salicylate 0.06%, thymol 0.064%), packa…

Vi-Jon, LLC

FDA Drug Moderate Sep 27, 2023

Rasagiline Tablets 0.5mg, 30-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A., NDC 0378-1270-93

Aurobindo Pharma USA Inc.

FDA Drug Low Sep 27, 2023

Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx only, Manufactured for Sun P…

SUN PHARMACEUTICAL INDUSTRIES INC

FDA Drug Moderate Sep 27, 2023

TRP Natural Eyes, Blur Relief, Sterile Eye Drops, Homeopathic 0.5 FL OZ (15 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delu…

AMMAN PHARMACEUTICAL INDUSTRIES

FDA Drug Moderate Sep 27, 2023

TRP Natural Eyes, Pink Eye Relief, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575…

AMMAN PHARMACEUTICAL INDUSTRIES

FDA Devices Moderate Sep 27, 2023

MEDLINE STERILE IRIS SCISSORS CVD/STD, REF DYNJ04049

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Sep 27, 2023

DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106

Encore Medical, LP

FDA Devices Moderate Sep 27, 2023

Patient Information Center iX with Software Version Number 4.x in the following: (1) Patient Information Center iX Product Number: 866389; (2) P…

Philips North America Llc

FDA Devices Moderate Sep 27, 2023

VITROS XT Chemistry Products ALKP Slides

Ortho-Clinical Diagnostics, INc.

FDA Devices Moderate Sep 27, 2023

Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle-Allows the user to mix bone cement witha constant high vacuum throug…

Stryker Corporation

FDA Devices Moderate Sep 27, 2023

Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only

Karl Storz Endoscopy

FDA Devices Moderate Sep 27, 2023

Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter, intravascular

ARROW INTERNATIONAL Inc.

FDA Devices Moderate Sep 27, 2023

APK2 Pressure-Sensing Wheelchair Cushions

Aquila Corporation

FDA Devices Critical Sep 27, 2023

Hamilton C1/T1/MR1, REF: MSP161502/12, Control Board Spare part for ventilator

Hamilton Medical, Inc.

FDA Devices Critical Sep 27, 2023

Hamilton-T1, REF: 161006, Intensive Care and Transport Ventilator

Hamilton Medical, Inc.

FDA Devices Moderate Sep 27, 2023

TyTek Tension Pneumothorax Access Kit TPAK 14 gauge 3.25 inch- Intended for introduction into the body to facilitate removal of air from the pleural …

Tytek Medical Inc

FDA Devices Moderate Sep 27, 2023

Gallant VR Implantable Cardioverter Defibrillator: VR ICD REF CDVRA500Q Gallant DR Implantable Cardioverter Defibrillator: DR ICD REF CDDRA500Q …

Abbott Medical

FDA Devices Moderate Sep 27, 2023

Stryker ACM (Advanced Cement Mixing) System: Break-Away Femoral Nozzle-, Allows the user to mix bone cement with a constant high vacuum through the …

Stryker Corporation

FDA Devices Moderate Sep 27, 2023

Perifix¿ / Epidural anesthesia set, medicated

B. Braun Medical, Inc.

FDA Devices Moderate Sep 27, 2023

Membrane Changer Single-Use, REF MC, each package contains 3 changers; Membrane Changer Reloadable, REF MC-R, each package contains 3 changers; and M…

SenTec AG

FDA Devices Moderate Sep 27, 2023

Stryker ACM (Advanced Cement Mixing): 180-Gram Cement Cartridge with Breakaway Femoral Nozzle-Allows the user to mix bone cement with a constant high…

Stryker Corporation

FDA Devices Moderate Sep 27, 2023

DJO Surgical: Delta Ceramic Femoral Head, 44 mm + 4.0 mm, REF: 400-03-443

Encore Medical, LP

FDA Devices Critical Sep 27, 2023

Hamilton-MR1, REF: 161010, Intensive Care Ventilator

Hamilton Medical, Inc.

FDA Devices Critical Sep 27, 2023

Hamilton-C1, REF: 161001, Portable Intensive Care Ventilator

Hamilton Medical, Inc.

FDA Devices Moderate Sep 27, 2023

Omnipod 5 Automated Insulin Delivery System

Insulet Corporation

FDA Devices Moderate Sep 27, 2023

DJO Surgical: CLP Hip, Stem, Polished Neck, Lateral Offset Implant, Size#3, REF: 426-11-030

Encore Medical, LP

FDA Devices Moderate Sep 27, 2023

DJO Surgical: Reverse Shoulder System (RSP) Semi Humeral Socket Insert, 32mm, REF: 508-01-032; Baseplate, Glenoid HA-Coat, RSP, 6.5mm X 30mm, REF: 50…

Encore Medical, LP

FDA Devices Moderate Sep 27, 2023

COPAN REF: 2U045S01 300uL Transfer Pipette Individually wrapped pipettes, 1000 pcs.

Copan Diagnostics Inc

FDA Devices Critical Sep 27, 2023

Hamilton-T1, REF: MSP161339/02, ESM Shielding Set, Spare Part for ventilator

Hamilton Medical, Inc.

FDA Devices Moderate Sep 27, 2023

Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, and 00-1007, when Used With Tempus Pro Video Laryngosco…

Remote Diagnostic Technologies Ltd.

FDA Devices Critical Sep 27, 2023

Hamilton-T1, REF: 161009, Intensive Care and Transport Ventilator

Hamilton Medical, Inc.

FDA Devices Moderate Sep 27, 2023

Arrow ErgoPack, Pressure Injectable Two-Lumen PICC pre-loaded with Arrow VPS Stylet, REF CDC-35552-VPS; Catheter: Percutaneous, implanted, long-term …

ARROW INTERNATIONAL Inc.

FDA Devices Moderate Sep 27, 2023

PDS Plus Antibacterial (polydioxanone) Suture, Product Numbers PDP072H40, PDP259H50, PDP416H50, PDP441H50, PDP442H50, PDP489G50, PDP489H40, PDP497G51…

ETHICON, LLC

FDA Devices Moderate Sep 27, 2023

VITROS XT Chemistry Products TBIL-ALKP Slides

Ortho-Clinical Diagnostics, INc.

FDA Devices Moderate Sep 27, 2023

Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle, Restrictors & Prox. Med. Press- Allows the user to mix bone cement w…

Stryker Corporation

FDA Devices Moderate Sep 27, 2023

FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size small, Product Code 46827

O&M HALYARD, INC.

FDA Devices Moderate Sep 27, 2023

Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle, Restrictors & Prox. Press-Allows the user to mix bone cement with a …

Stryker Corporation

FDA Devices Moderate Sep 27, 2023

Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle & Solid Blades-Allows the user to mix bone cement with a constant hi…

Stryker Corporation

FDA Devices Moderate Sep 27, 2023

Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press-Allows the user to mix bone cement with a constan…

Stryker Corporation

FDA Devices Moderate Sep 27, 2023

Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model 5875569, used with CardioLab AltiX and ComboLab AltiX.

GE Medical Systems Information Technologies Inc

FDA Devices Moderate Sep 27, 2023

smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee joint

Smith & Nephew Inc

FDA Devices Moderate Sep 27, 2023

TyTek PneumoDart- Intended for introduction into the body to facilitate removal of air from the pleural cavity in patients with a tension pneumothora…

Tytek Medical Inc

FDA Devices Moderate Sep 27, 2023

TyTek Tension Pneumothorax Access Kit TPAK10: 10 gauge, 3.25 inch- Intended for introduction into the body to facilitate removal of air from the pleu…

Tytek Medical 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 - consumer product and vehicle recall feeds for 2023

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Figures cover calendar year 2023 across the FDA, CPSC and NHTSA federal recall feeds. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.