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

2851–2875 of 27346

HighFDA (Devices)·Z-1485-2025·2025-04-09
GE Healthcare Centricity Radiology RA600 and related imaging systems login vulnerability
GE Healthcare is recalling Centricity Radiology RA600 and related imaging systems due to a security vulnerability allowing service login credentials to be identified, potentially exposing patient data to unauthorized access.
Product
GE Healthcare Centricity Radiology RA600 (RA600), Model Numbers: 1) 2022296-001; 2) 2033901-001; 3) 2038437-001; 4) 2038437-011; 5) 2038437-012; 6) 2038437-013; 7) 2038437-014; 8) 2038437-0XX; 9) 2098071-004; 10) 2109571-002; 11) 2109571-006; 12) 2109571-
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1471-2025·2025-04-09
Nasopore Standard Nasal Dressing Recalled Due to Sterility Seal Defects
Stryker is recalling 182,344 units of Nasopore Standard nasal dressings nationwide due to potential bubbles in blister seals that may breach the sterility barrier and increase contamination risk.
Product
Nasopore Standard 8cm fragmentable nasal dressing, Catalog Numbers 5400-010-008 and 5400-010-008ITL
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1482-2025·2025-04-09
Stryker nasal wound dressing recalled for defective sterile packaging seal
Stryker Corporation is recalling 182,344 units of Hemopore 2PK nasal/sinus wound dressing due to potential bubbles in blister seals that indicate sterility breach. Affected lot numbers are 2024020221, 2024051720, and 2024082321.
Product
Hemopore 2PK nasal/sinus temporary wound dressing, Catalog Number 5400-222-208S
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1489-2025·2025-04-09
Stryker Spine Monterey AL Implant Inserter Gold Unlock Button Separation Recall
Stryker Spine has recalled 56 units of the Monterey AL Implant Inserter due to potential separation of the gold unlock button. This could impair the device's function during surgical implant placement.
Product
Monterey AL Implant Inserter; 14/16mm; Catalog 48019120.
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-1477-2025·2025-04-09
Hemopore nasal wound dressing packaging seal defect may compromise sterility
Stryker Corporation is recalling 182,344 units of Hemopore nasal/sinus wound dressing due to potential packaging seal defects that could compromise sterility. A bubble on the blister seal may indicate the sterile barrier has been breached.
Product
Hemopore 8cm nasal/sinus temporary wound dressing, Catalog Numbers 5400-020-208 and 5400-020-208ITL (OUS)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1475-2025·2025-04-09
Otopore Square Outer Ear Wound Dressing Recall for Sterility Seal Defect
Stryker Corporation is recalling Otopore Square outer ear wound dressings nationwide because sterile packaging seals may develop bubbles, indicating a potential breach of the sterile barrier. Consumers should stop using affected units and contact their healthcare provider.
Product
Otopore Square outer ear wound dressing, Firm Catalog Number 5400-020-100 and Forte Catalog Number 5400-020-100ITL
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1508-2025·2025-04-09
Boppli Bedside Device Kit blood pressure monitor may fail to detect pressure changes
Boppli bedside blood pressure monitors for infants may not adequately detect blood pressure changes due to vibratory noise. Affected monitors should be moved to patient's foot and ventilator lines kept away from the isolette.
Product
Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1481-2025·2025-04-09
Nasopore Nasal Dressings Recalled Due to Breached Sterility Seals
Stryker Corporation is recalling Nasopore nasal dressings due to potential breaches in packaging sterility seals that could compromise product sterilization. Approximately 182,344 units have been distributed nationwide.
Product
Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK Catalog Number 5400-222-004S
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1510-2025·2025-04-09
Cordis Smart Control Vascular Stent Size Mismatch Recalled
Cordis recalled 20 units of its Smart Control Vascular Stent System ILIAC due to a labeling mix-up where the external label does not match the actual stent size. Wrong-sized stents could cause serious vessel complications if implanted.
Product
Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx Only
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-1515-2025·2025-04-09
Ethicon PROLENE BLU Surgical Sutures Recalled for Manufacturing Defect
Ethicon is recalling specific lots of PROLENE BLU surgical sutures due to silicone curing issues during needle manufacturing.
Product
PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1492-2025·2025-04-09
Terumo CDI OneView Monitor Probe May Fail to Display Oxygen Saturation Data
Terumo's CDI OneView Hematocrit/Oxygen Saturation Probe may intermittently fail to display oxygen saturation values during clinical use. When this occurs, the monitor displays dashes and triggers a yellow low-limit alarm.
Product
Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-1473-2025·2025-04-09
Stryker Nasopore Nasal Dressing Recalled for Compromised Sterility Seals
Stryker's Nasopore 8cm nasal dressing is being recalled because packaging seals may have bubbles indicating the sterility barrier has been breached. The recall affects 182,344 units distributed nationwide.
Product
Nasopore 8cm fragmentable nasal dressing, Firm Catalog Number 5400-020-008 and Forte Catalog Number 5400-020-008ITL
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1476-2025·2025-04-09
Nasopore FD nasal dressing recalled for potential sterile barrier breach
Stryker Corporation is recalling 182,344 units of Nasopore FD nasal dressing nationwide due to potentially breached sterile seals that may allow product contamination.
Product
Nasopore FD fragmentable nasal dressing, Catalog Numbers 5400-020-108 and 5400-020-108ITL
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1511-2025·2025-04-09
Cordis Vascular Stent System Recalled Due to Incorrect Product Size
Cordis US Corp recalls Smart Control Vascular Stent System ILIAC devices due to product mix-up where some units are labeled 9mm X 60mm but contain different stent sizes. Patients should consult their healthcare provider immediately.
Product
Cordis, REF: C09060ML, Smart Control Vascular Stent System ILIAC, 9mm X 60mm 6F, SterileEO, Rx Only
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-1480-2025·2025-04-09
Nasopore Nasal Dressing Recall Due to Compromised Sterile Packaging Seals
Stryker Corporation is recalling Nasopore nasal dressings due to potentially compromised sterile packaging seals. Affected units totaling 182,344 may have lost sterility, posing a contamination risk.
Product
Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK Catalog Number 5400-222-004S
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1504-2025·2025-04-09
Respiratory Diagnostic Cartridges Recalled for Risk of False Test Results
Qiagen is recalling 445 QIAstat-Dx Respiratory Panel Plus cartridges due to faulty units that could produce false test results. Affected devices distributed to 12 US states should not be used.
Product
Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Number (REF): 691224 Software Version: n/a Component: n/a
Category
Medical Device
Distribution
12 states
HighFDA (Devices)·Z-1483-2025·2025-04-09
GE Healthcare Medical Imaging Software Vulnerability Allows Unauthorized System Access
GE Healthcare's Centricity medical imaging software has a security vulnerability that allows service login credentials to be identified. A malicious actor could exploit this to access or manipulate patient data.
Product
GE Healthcare Centricity Universal Viewer (UV), Model Numbers: 1) 2066908-077; 2) 2066908-136; 3) 2066908-150; 4) 2088026-003; 5) 2088026-026; 6) 2088026-032; 7) 2088026-043; 8) 2088026-110; 9) 2088026-115; 10) 2088026-132; 11) 2088026-306; 12) 2088026-308;
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1484-2025·2025-04-09
GE Healthcare PACS-IW Software Security Vulnerability Affects Patient Data Access
GE Healthcare recalled Centricity PACS-IW and related medical imaging software due to a security vulnerability allowing service credentials to be identified, potentially enabling unauthorized system access and patient data manipulation.
Product
GE Healthcare Centricity PACS-IW (PACS-IW), Model Numbers: 1) 2042988-001; 2) 2049587-009; 3) 2049587-011; 4) 2049587-012; 5) 2049587-015; 6) 2049588-012 ; 7) 2052829-001.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1502-2025·2025-04-09
Diagnostic reagent recalls incorrect ISI value on Pacific Hemostasis Thromboplastin-D
Fisher Diagnostics is recalling Pacific Hemostasis Thromboplastin-D due to an incorrect International Sensitivity Index (ISI) value printed on the outer box label. The error could affect interpretation of prothrombin time test results.
Product
Pacific Hemostasis Thromboplastin-D, 4 ml. Used in performing one-stage prothrombin time test and factor assays.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1487-2025·2025-04-09
GE Healthcare medical imaging systems security vulnerability could allow data access
GE Healthcare Centricity imaging systems contain a security vulnerability where service login credentials can be identified. This could allow unauthorized access and potential patient data manipulation.
Product
GE Healthcare Centricity Centricity PACS-IW with Universal Viewer, Model Numbers: 1) 2049587-015; 2) 2066908-086; 3) 2066908-136; 4) 2104867-045.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1470-2025·2025-04-09
Nasopore nasal dressing may have compromised sterile packaging
Stryker is recalling Nasopore Standard 4cm nasal dressings because the blister seals may develop bubbles, potentially compromising the sterility barrier. Affected units should not be used.
Product
Nasopore Standard 4cm fragmentable nasal dressing, Catalog Numbers 5400-010-004 and 5400-010-004ITL
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1472-2025·2025-04-09
Otopore Cylinder Wound Dressing Recalled for Potential Sterility Seal Defect
Stryker Corporation recalls Otopore Cylinder outer ear wound dressing due to potential bubbles in blister seals that may breach the sterile barrier. Affected units were distributed nationwide.
Product
Otopore Cylinder outer ear wound dressing, Firm Catalog Number 5400-020-000 and Forte Catalog Number 5400-020-000TL
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1517-2025·2025-04-09
Clinical Chemistry Analyzer Recalled for Software Defect in Test Result Calculation
Beckman Coulter is recalling certain DxC 500 AU Clinical Chemistry Analyzers due to a software defect that prevents calculated test results from being recalculated when constituent tests are rerun, potentially delaying patient result reporting.
Product
DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1491-2025·2025-04-09
Stryker Spine Monterey AL Implant Inserter Recalled for Potential Unlock Button Separation
Stryker Spine is recalling the Monterey AL Implant Inserter (22mm, Catalog 48019140) due to potential separation of the gold unlock button from the device. The recall affects 41 units in the United States and 3 internationally.
Product
Monterey AL Implant Inserter; 22mm; Catalog 48019140.
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-1516-2025·2025-04-09
Surgical Suture Recall Due to Silicone Curing Defect
Ethicon Endo Surgery recalls ETHIBOND EXCEL surgical sutures worldwide due to curing issues with the silicone coating on the needles identified during manufacturing.
Product
ETHIBOND EXCEL GRN 36IN(90CM) USP2-0(M3) D/A MH
Category
Medical Device
Distribution
Distributed nationwide

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2851–2875 of 27346