Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

9701–9725 of 13748

ModerateFDA (Devices)·Z-1317-2023·2023-04-05
Shoulder Glenoid Prosthesis Implant Manufactured Without Tantalum Markers
A shoulder glenoid prosthesis implant (SMR TT Hybrid Std - Peg S) was manufactured without tantalum markers that aid in radiographic visualization. While alternative assessment methods using joint space, peg position, and cement observation remain available, the missing markers limit direct imaging capabilities.
Product
SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1308-2023·2023-04-05
MicroVue C1-Inhibitor Plus EIA kits recalled for potential test failure
Quidel is recalling specific lots of MicroVue C1-Inhibitor Plus EIA test kits that may produce low optical density values and invalid test results.
Product
MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor protein in human plasma or serum, Catalog Number A037, Containing Coated Strips, REF: 4634, with an ID number of 2200 or above
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1299-2023·2023-04-05
PCR Reagent Recalled for Misleading Label Statements
Entopsis, Inc. is recalling 397 units of PCRopsis Reagent RVD with RVD Enhancer due to misleading label statements. The affected products were distributed nationwide and internationally.
Product
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-free PCR from saliva, urine, &swab specimens in transport medium, nucleic acid extraction from a variety of biological samples
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1296-2023·2023-04-05
PCRopsis Reagent Buccal Kit Recalled for Misleading Label Statements
Entopsis, Inc. is recalling PCRopsis Reagent Buccal (REF 282001), an extraction-free PCR reagent kit, due to misleading label statements on the product labeling.
Product
PCRopsis Reagent Buccal, IVD, REF 282001; Extraction-free PCR from bucca; swabs (no transport medium) ,nucleic acid extraction from a variety of biological samples
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1305-2023·2023-04-05
ACL ELITE PRO-Analyzer: HemosIL Liquid Anti-Xa test definition removed
Instrumentation Laboratory is removing the HemosIL Liquid Anti-Xa test definition from ACL ELITE/Elite Pro analyzers used in clinical hemostasis laboratories. No illnesses or injuries have been reported.
Product
ACL ELITE PRO-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0001000311
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1298-2023·2023-04-05
Medical device lysis beads recalled for misleading label statements
Entopsis recalls PCRopsis Lysis Beads (363 units) due to misleading label statements on the product packaging. The affected product was distributed nationwide and to Canada, UK, Portugal, Spain, Germany, Brazil, Denmark, South Korea, Colombia, and Lithuania.
Product
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, REF 5971000; coated beads that facilitate lysis of microorganisms; nucleic acid extraction from a variety of biological samples
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1281-2023·2023-03-29
Raystation Treatment Planning System Collimator Angle Export Defect
Raystation radiation therapy planning software may not correctly export collimator angle settings when using the DICOM export function. In exported files, the collimator angle may be replaced with zero regardless of the user's selection.
Product
Raystation treatment planning system for radiation therapy, Model Numbers 9.0.0, 9.0.1, 9.1.0, 9.2.0, 10.0.0, 10.0.1, 10.0.2, 10.1.0, 10.1.1, 11.0.0, 11.0.1, 11.0.3, 11.0.4, 12.0.0, 12.1.0, 12.1.1, 12.0.3, 12.1.2, 12.0.4, 12.1.3, 13.0.0, 13.1.0. Software Version Numbers 9A, 9B,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1278-2023·2023-03-29
Cardiosave IABP Safety Disk Model 0202-00-0140 Recalled for Performance Defect
Datascope Corp. is recalling 669 Cardiosave IABP Safety Disks due to a performance defect that may reduce balloon inflation during cardiac support therapy. The affected devices may not provide adequate augmentation to patients requiring mechanical circulatory support.
Product
Cardiosave Intra-Aortic Balloon Pump (IABP) Safety Disk, Model Number 0202-00-0140
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1284-2023·2023-03-29
G7 Acetabular Liner Recalled for Size and Label Discrepancy
Biomet recalled 12 units of its G7 Acetabular System 40mm Size D Liner because the actual implant is a 38mm Size C. The mismatch between outer labeling and the actual implant could result in wrong-size component placement during surgery.
Product
G7 Acetabular System, Dual Mobility Acetabular Liner, 40 mm, Size D, Model Number 110024462
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-1266-2023·2023-03-29
Attune Revision Tibial Insert Recalled for Excessive Gamma Radiation Exposure
DePuy Orthopaedics is recalling 7 units of the Attune Revision Tibial Insert that received excess gamma radiation during manufacturing, which may degrade implant material properties.
Product
Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part Number 151760312
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1277-2023·2023-03-29
Cardiosave Hybrid Intra-Aortic Balloon Pump Performance Issue Recall
Datascope Corp. is recalling specific Cardiosave Hybrid intra-aortic balloon pumps due to a Safety Disk performance issue that may reduce balloon inflation and therapeutic benefit.
Product
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1272-2023·2023-03-29
Disposable Patient Circuit with Precision Flow System recalled for excessive condensation
Vapotherm has recalled 5,869 Low Flow Disposable Patient Circuits for the Precision Flow System due to reports of excessive condensation that may lead to rainout.
Product
Low Flow Disposable Patient Circuit for the Precision Flow System, Product Code PF-DPC-LOW
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1207-2023·2023-03-29
BD Pyxis Automated Medication Dispensing Systems Firmware Downgrade Recall
CareFusion recalls 7,914 units of BD Pyxis automated medication dispensing systems after firmware was inadvertently downgraded during installation, potentially causing drawer failures and medication delivery delays.
Product
BD Pyxis Anesthesia ES System (PAS ES), REF: 327; BP Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES Tower (Med ES Tower), REF: 352; all with BD Pyxis ES version 1.6.1 drawer firmware (version 1.10.2.5). Pyxis MedStation Enterprise Server (ES) System is an a
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1280-2023·2023-03-29
Wearable ECG smartwatch software bug eliminates physician review
Withings Scan Monitor/ScanWatch (model hwa09) has a software defect preventing physicians from reviewing ECG recordings, which is critical to the device's FDA clearance requirement for physician-supervised use. Users should discontinue use until the defect is corrected.
Product
Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected wrist watch that records heart activity (ECG) and oxygen saturation (SpO2)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1265-2023·2023-03-29
Attune Revision Limb Preservation System Tibial Insert Recalled for Over-Irradiation
DePuy Orthopaedics is recalling 7 units of the Attune Revision Limb Preservation System Tibial Insert (Lot JP9022) that received higher than specified gamma radiation doses. The over-irradiation may cause changes to implant material properties.
Product
Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 26MM, Part Number 151760226
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1276-2023·2023-03-29
Cardiosave Hybrid intra-aortic balloon pump safety disk defect may reduce therapy efficacy
Datascope's Cardiosave Hybrid intra-aortic balloon pump may have a faulty Safety Disk that reduces balloon inflation and cardiac augmentation. No injuries reported.
Product
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, and 0998-00-0800-65
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1263-2023·2023-03-29
Orthopedic Implant Recall: Excessive Radiation Exposure in Revision Tibial Insert
DePuy Orthopaedics recalls 7 units of Attune Revision LPS Tibial Inserts (Part 151760118, Lot JP6452) distributed worldwide due to excessive gamma radiation during manufacturing. This overage may result in material property changes.
Product
Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number 151760118
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1264-2023·2023-03-29
Orthopedic Tibial Insert Recalled Due to Excessive Radiation Exposure
DePuy Orthopaedics is recalling Attune Revision LPS Tibial Insert devices (Lot JP9016) because they received excessive gamma radiation during manufacturing, which may compromise material properties.
Product
Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 12MM, Part Number 151760212
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1267-2023·2023-03-29
DePuy Attune Tibial Insert Recalled for Excessive Radiation Exposure
DePuy Orthopaedics is recalling Attune Posterior tibial insert implants that received excessive gamma radiation during manufacturing, which may degrade the material properties of the knee replacement component.
Product
Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 151640507
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1279-2023·2023-03-29
Cardiosave IABP Pneumatic Interface Module Recalled for Performance Issue
Datascope Corp. recalls the Cardiosave IABP Pneumatic Interface Module due to a Safety Disk performance issue that may reduce balloon inflation. Ten specific units with identified serial numbers are affected.
Product
Cardiosave Intra-Aortic Balloon Pump (IABP) Pneumatic Interface Module (PIM) , Model Number 0997-00-1178
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1282-2023·2023-03-29
Contact Lens Recall: CooperVision Clariti 1-day Toric With Incorrect Power
CooperVision is recalling Clariti 1-day toric contact lenses from lot W0124677 because they were made with a misaligned axis that results in incorrect lens power.
Product
Clariti 1-day toric soft contact lenses, Power -1.00 -1.25/90
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1283-2023·2023-03-29
DeRoyal Suction Canister Recalled Due to Lid Shrinkage Seal Defect
DeRoyal SafeLiner Suction Canister model PHESL-1000B is being recalled due to lid shrinkage that prevents proper vacuum seal formation and maintenance. The recall affects 27,200 devices distributed across multiple US states.
Product
DeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000B
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1190-2023·2023-03-22
Closed Suction System Manifold Cracking Poses Respiratory Circuit Leak Risk
Avanos Medical recalls BALLARD ACCESS Closed Suction System units due to manifold cracking, which can cause respiratory circuit leaks and inadequate ventilation in neonatal and pediatric patients.
Product
BALLARD* ACCESS Closed Suction System for Neonates/Pediatrics, Elbow Manifold.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1189-2023·2023-03-22
BALLARD ACCESS Closed Suction System Manifold May Crack and Leak
Avanos Medical is recalling 780 units of the BALLARD ACCESS Closed Suction System due to manifold cracking that can leak the respiratory circuit, potentially causing inadequate ventilation in neonatal and pediatric patients.
Product
BALLARD ACCESS Closed Suction System for Neonates/Pediatrics, Y-Manifold.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1241-2023·2023-03-22
BD Insulin Syringes Recalled for Potential Nonsterile Condition
Becton Dickinson & Company is recalling 1.17 million BD Ultra-Fine Insulin Syringes due to a nonsterile manufacturing defect that could expose patients to pathogenic microorganisms and increase infection risk.
Product
BD Ultra-Fine Insulin Syringe 1mL, 6mm, 31G-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 326678
Category
Medical Device
Distribution
Distributed nationwide

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9701–9725 of 13748