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

3801–3825 of 13449

ModerateFDA (Devices)·Z-1120-2025·2025-02-19
BD Pyxis Medication Dispensing Systems Recalled for Insufficient Labeling
CareFusion is recalling six models of BD Pyxis medication management systems due to insufficient labeling regarding potential delays in medication access. The manufacturer is strengthening product labeling to address this risk.
Product
(1) BD Pyxis MedStation ES, Catalog No. 323; (2) BD Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) BD Pyxis MedStation ES Tower, Catalog No. 352; (4) BD Pyxis MedStation 4000 Console, Catalog No. 309; (5) BD Pyxis MedStation 4000, Catalog No. 303; (6) BD Pyxis Anesthes
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1123-2025·2025-02-19
BD Pyxis MedStation Auxiliary ES medication cabinet drawer and door failures
BD Pyxis MedStation Auxiliary ES medication cabinets are being recalled due to potential drawer and door failures following increased complaints. The failures could delay access to medications stored in the cabinet.
Product
BD Pyxis MedStation Auxiliary ES REF: 324. Intended to securely store and dispense medications to a qualified and authorized healthcare provider.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1019-2025·2025-02-12
Ivenix Infusion System software recalled for pump malfunction risk
The FDA recalled Ivenix Infusion System software versions 5.9.2 and earlier for potential device malfunctions that could affect medication delivery. Two known anomalies may cause pump failure or improper infusion rates.
Product
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration.
Category
Medical Device
Distribution
15 states
HighFDA (Devices)·Z-1084-2025·2025-02-12
Philips Allura and Azurion Patient Tables Recall Due to Finger Entrapment Risk
Philips is recalling AD7 and AD7X patient tables used in Allura and Azurion medical imaging systems due to a finger entrapment hazard during manual repositioning. Operators and service personnel are at risk of finger injury.
Product
AlluraXperFD20/10 System Code: (1) 722029
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1114-2025·2025-02-12
Endodontic Files Recalled for Excess Irradiation Causing Package Integrity Issues
US Endodontics is recalling endodontic files due to irradiation above specification, which may compromise package integrity. The recall affects 789,729 devices distributed in the US and internationally.
Product
Brasseler ESR Rotary/Reciprocating Endodontic File Device SKU AP120213PK AP120253PK AP120313PK AP125213PK AP125253PK AP125313PK AP135213PK AP135253PK AP135313PK AP145213PK AP145253PK AP145313PK AP1GP213PK AP1GP253PK AP1GP313PK O.U.S. Products: EdgeFile X7 REF
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1089-2025·2025-02-12
Philips Azurion 5 M12 imaging system: finger entrapment risk during tabletop repositioning
Philips Azurion 5 M12 patient imaging systems pose a finger entrapment hazard during manual tabletop repositioning. Operators and service personnel risk finger injury from the longitudinal guiding rails.
Product
Azurion 5 M12 System Code: (1) 722227 (2) 722231
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1046-2025·2025-02-12
X-Ray Imaging System May Continue Exposure Beyond Safety Limit
GE Medical Systems' Optima XR646 HD X-Ray imaging systems may allow continued radiation exposure beyond the safety limit without operator confirmation. A warning message displays but does not prevent the excess exposure.
Product
Optima XR646 HD. X-Ray imaging system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1082-2025·2025-02-12
Philips AlluraXper FD20 operating room surgical table finger entrapment risk
Philips AlluraXper FD20 operating room tables can trap fingers during manual repositioning, risking injury. The hazard affects both operators and service personnel worldwide.
Product
AlluraXper FD20 Biplane OR Table System Code: (1) 722020 (2) 722025
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1118-2025·2025-02-12
Spine Surgery Planning Software Calculation Errors in Rod Planning Parameters
Medicrea International is recalling UNiD Spine Analyzer software due to calculation errors in rod planning parameters. The software experienced anomalies resulting in incorrect values for surgical classification and measurement parameters used in spine surgery planning.
Product
UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929 Two cloud-based software applications within UNiD Adaptive Spine Intelligence (ASI): the UNiD HUB and the UNiD Spine Analyzer. The UNiD HUB cloud-based software is a he
Category
Medical Device
Distribution
50 states
HighFDA (Devices)·Z-1101-2025·2025-02-12
Dental implants recalled for manufacturing defect affecting sterile packaging
Nobel Biocare recalled N1 TiUltra TCC dental implants due to a manufacturing defect that may puncture the sterile blister packaging. The defect is a sharp pin created during injection molding that could compromise product sterility.
Product
. Nobel Biocare N1 TiUltra TCC RP 4.0x9mm . Nobel Biocare N1 TiUltra TCC RP 4.0x11mm . Nobel Biocare N1 TiUltra TCC RP 4.0x13mm Nobel Biocare N1 TiUltra TCC implants are intended for use as an endosseous dental implant in the maxilla or mandible for anchoring or supporting
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1087-2025·2025-02-12
Philips Azurion and Allura Patient Tables: Finger Entrapment Hazard
Philips patient tables on Azurion and Allura imaging systems can trap fingers between the tabletop and rails during manual repositioning. Operators and service personnel are at risk of finger injury.
Product
Azurion 3 M12 System Code: (1) 722063 (2) 722221
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1090-2025·2025-02-12
Philips Azurion 5 M20 Patient Tables Recalled for Finger Entrapment Hazard
Philips Azurion 5 M20 x-ray system patient tables can trap fingers between the tabletop and guiding rails during repositioning. The hazard may cause finger injury to operators and service personnel.
Product
Azurion 5 M20 System Code: (1) 722228 (2) 722232 (3) 722281
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1076-2025·2025-02-12
Philips Allura CV20 patient tables risk finger entrapment during repositioning
The Philips Allura CV20 System patient tables (AD7 and AD7X models) pose a finger entrapment hazard during manual repositioning. Fingers can become caught between the tabletop and guiding rails, potentially injuring operators and service personnel.
Product
Allura CV20 System Code: 722031
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1093-2025·2025-02-12
Philips Azurion patient tables recalled for finger entrapment risk
Philips is recalling Azurion 7 M12 and Allura patient tables used in medical imaging systems due to a finger entrapment hazard during manual repositioning. Operators and service personnel may suffer finger injury if fingers are caught between the tabletop and guiding rails.
Product
Azurion 7 M12 System Code: (1) 722078 (2) 722223 (3) 722233
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1094-2025·2025-02-12
Philips Azurion and Allura Patient Table Finger Entrapment Risk
Philips Azurion 7 M20 and Allura patient tables pose a finger entrapment risk during manual repositioning. Fingers can get caught between the tabletop and guiding rails, potentially causing finger injury to operators and service personnel.
Product
Azurion 7 M20 System code: (1) 722224 (2) 722079 (3) 722234 (4) 722282 System Code: (1) 722078 (2) 722223 (3) 722233
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1091-2025·2025-02-12
Philips Azurion and Allura System Patient Tables: Finger Entrapment Risk
Philips Azurion and Allura system patient tables may trap fingers between the guiding rails and tabletop during manual repositioning, risking finger injury to operators and service personnel.
Product
Azurion 7 B12 System Code: (1) 722067 (2) 722225 (3) 722235
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1075-2025·2025-02-12
Levofloxacin Antimicrobial Susceptibility Discs Recalled Due to Packaging Mislabeling
Oxoid Limited is recalling 1,406 units of Lev5 Levofloxacin susceptibility discs because packaging may contain Norfloxacin discs instead, which could affect laboratory test results.
Product
Lev5, REF CT1587B, 50 Susceptibility discs Levofloxacin 5 ug, IVD, CE 2797
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-1079-2025·2025-02-12
Philips Allura patient tables recall due to finger entrapment risk
Philips recalls AD7 and AD7X patient tables in Allura and Azurion systems due to finger entrapment risk during manual repositioning. Operators and service personnel could suffer finger injuries.
Product
Allura Xper FD10C System Code: (1) 722001
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1077-2025·2025-02-12
Philips AD7 and AD7X patient tables recalled due to finger entrapment risk
Philips has recalled the AD7 and AD7X patient tables used in medical imaging systems because fingers can become entrapped between the tabletop and guiding rails during manual repositioning, potentially causing injury.
Product
Allura Xper FD10 Catalog (1) 722003 (2) 722010 (3)722026
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1110-2025·2025-02-12
IntelliVue Patient Monitor MX550 May Fail to Alarm on Ventilator Disconnection
Philips IntelliVue Patient Monitor MX550 units may fail to generate an alarm when a Hamilton ventilator is disconnected, creating a patient safety risk. The monitor could remain silent without alerting clinical staff.
Product
IntelliVue Patient Monitor MX550. Model Number: 866066
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1105-2025·2025-02-12
NeiMed NasoGel nasal spray recalled due to stability failure
Neilmed Pharmaceuticals is recalling NasoGel for Dry Noses due to stability failure that may allow microbial growth. The product was distributed across 30 U.S. states and to five countries.
Product
NeiMed NasoGel for DRY NOSES UDI-DI/UPC code: 00705928045309 SKU GSP30-2R-48-ENU-USL GSP30-0R-96-ENU-USL GSP30-ARA-INTL GSP30-SWE-INTL GSP30-ENG-INT GSP30-MAL-INTL GSP30-SPA-INT NasoGel Spray is a saline-based gel formula that can be sprayed to moisturize and lubricate dry and i
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1080-2025·2025-02-12
Philips recalls AlluraXper FD20 patient tables due to finger entrapment hazard
Philips is recalling AlluraXper FD20 patient tables due to a finger entrapment hazard. During manual repositioning, fingers can get trapped between the tabletop and rails, risking injury to operators and service personnel.
Product
AlluraXper FD20 System Code: (1) 722006 (2) 722012 (3) 722028
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1088-2025·2025-02-12
Philips Azurion Patient Tables Recalled for Finger Entrapment Risk
Philips Azurion patient tables used in medical imaging systems can trap fingers between the tabletop and rails during manual repositioning, potentially causing finger injury to operators and service personnel.
Product
Azurion 3 M15 System Code: (1) 722064 (2) 722222 (3) 722280
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1092-2025·2025-02-12
Philips Azurion patient tables recalled for finger entrapment hazard
Philips is recalling Azurion 7 B20 patient tables due to a finger entrapment hazard between the tabletop and guiding rails during manual repositioning. Operators and service personnel could suffer finger injury.
Product
Azurion 7 B20 System Code: (1) 722068 (2) 722226 (3) 722236
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1073-2025·2025-02-12
VNS Therapy Generator May Stop Delivering Stimulation Due to Mechanical Defect
LivaNova's SenTiva VNS generators (48 units) may stop delivering stimulation due to a mechanical defect. Patients may experience return to baseline seizure or depressive symptoms and may require replacement surgery.
Product
SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst Stimulation. Used for Vagus Nerve Stimulation (VNS).
Category
Medical Device
Distribution
41 states

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3801–3825 of 13449