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

4601–4625 of 39987

HighFDA (Devices)·Z-1095-2025·2025-02-12
Hologic Rapid fFN Specimen Collection Tubes May Contain Incorrect Extraction Buffer Volumes
Hologic Rapid fFN Specimen Collection Tubes from three lots may contain incorrect amounts of extraction buffer, potentially causing invalid test results or diagnostic errors in preterm delivery assessment.
Product
The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rapid fFN Specimen Collection kit (PN: 71738-001). The Collection Tube (PN: 71550-001) is manufactured by a third-party supplier, MML Diagnostics Packaging, and includes the transport tube, cap, and extr
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1086-2025·2025-02-12
Philips AD7 and AD7X Patient Table Finger Entrapment Risk
The Philips AD7 and AD7X patient tables pose a finger entrapment risk during manual repositioning. Operators and service personnel could sustain finger injuries from the gap between the longitudinal guiding rails and tabletop.
Product
AlluraXperFD20/15 System Code: (1) 722058
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1106-2025·2025-02-12
IntelliBridge EC10 Module may fail to alarm on ventilator disconnection
The IntelliBridge EC10 Module may fail to sound an alarm when a Hamilton ventilator is disconnected. This could allow unnoticed disconnections that could affect patient monitoring.
Product
IntelliBridge EC10 Module. Model Number: 865115
Category
Medical Device
Distribution
2 states
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-1045-2025·2025-02-12
GE Discovery XR656 HD X-ray system AEC control malfunctions during imaging
GE Medical Systems is recalling the Discovery XR656 HD X-ray imaging system due to a malfunction in the Automatic Exposure Control (AEC) feature. The defect allows continued X-ray exposure beyond intended limits without requiring operator acknowledgment.
Product
Discovery XR656 HD. X-Ray imaging system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1111-2025·2025-02-12
Temporary Titanium Abutments May Fracture in Dental Implants
DDS Lab temporary titanium abutments may have been installed in some dental implant restoration cases instead of definitive abutments. The components may fracture, risking restoration loosening, oral tissue injury, and aspiration.
Product
Temporary Titanium Abutments
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-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-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-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-1097-2025·2025-02-12
PERMA-HAND Silk Sutures Recalled for Packaging Sterility Breach
Ethicon is recalling PERMA-HAND Silk Sutures that may have open seals on packaging due to manufacturing defects, risking sterility compromise and patient infection. Approximately 78,792 units were distributed nationwide and internationally.
Product
PERMA-HAND Silk Suture, REF: K872H, W723H, 623H, K833H; Perma-hand Silk Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurosurgical procedures.
Category
Medical Device
Distribution
Distributed nationwide
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-1044-2025·2025-02-12
Medical X-Ray System Permits Bypass of Radiation Exposure Control
GE Medical Systems' Discovery XR656HD X-Ray imaging systems can allow radiation exposures to exceed the Automatic Exposure Control limit without blocking further exposure. Approximately 3,149 units are affected worldwide, including 1,697 in the United States.
Product
Discovery XR656HD. X-Ray imaging system.
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-1109-2025·2025-02-12
IntelliVue Patient Monitor MX500 may fail to generate critical alarms
Philips IntelliVue Patient Monitor MX500 units may fail to generate "No Device Data" alarms when a Hamilton ventilator disconnects, potentially delaying notification of loss of connectivity. 45 units distributed in the US and internationally.
Product
IntelliVue Patient Monitor MX500. Model Number: 866064
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1043-2025·2025-02-12
X-Ray imaging systems may allow radiation exposure beyond safety limits
GE Medical Systems is recalling Definium 656HD and Discovery XR656HD X-Ray systems due to an Automatic Exposure Control defect that may allow radiation exposure to exceed intended safety limits.
Product
Definium 656HD & Discovery XR656HD (GTINs: 00840682138598, 00195278840226, 00840682136709). X-Ray imaging system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1085-2025·2025-02-12
Finger entrapment hazard in Philips Allura fluoroscopy patient tables
Philips is recalling AD7 and AD7X patient tables from Allura and Azurion fluoroscopy systems. During manual repositioning, fingers can become trapped between the guiding rails and tabletop, potentially causing injury.
Product
Allura Xper FD20/20 System Code: (1) 722038
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1096-2025·2025-02-12
FDA Recalls PROLENE Polypropylene Sutures for Defective Packaging Seals
Ethicon is recalling PROLENE polypropylene sutures because some packages have open seals due to a manufacturing defect. Defective seals may allow pathogens to contaminate the sterile sutures, potentially causing infection.
Product
PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurosurgical procedures.
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
2 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-1072-2025·2025-02-12
VNS Therapy Generators May Stop Delivering Stimulation Due to Component Failure
The SenTiva and SenTiva Duo vagus nerve stimulation generators may stop delivering therapy due to an internal mechanical component becoming stuck, causing potential loss of seizure and depression control.
Product
SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Therapy System. Used for Vagus Nerve Stimulation (VNS).
Category
Medical Device
Distribution
41 states
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-1108-2025·2025-02-12
Patient Monitor May Fail to Alert When Ventilator Disconnects
Philips IntelliVue Patient Monitor MX450 units may fail to sound an alarm when a Hamilton ventilator becomes disconnected, potentially delaying detection of the disconnection.
Product
IntelliVue Patient Monitor MX450. Model Number: 866062
Category
Medical Device
Distribution
2 states
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
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

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4601–4625 of 39987