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

326–350 of 39760

HighFDA (Devices)·Z-2728-2026·2026-07-22
Mobile Digital Radiographic System Arm Drop Risk During Patient Exams
GE HealthCare is recalling certain Optima XR200/220/240amx Mobile Digital Radiographic Systems due to potential failure of the Column Safety mechanism, which could cause the X-ray arm to drop during patient exams. The issue stems from incomplete functional testing of the safety pawl after column replacement.
Product
Optima XR240amx, Mobile Digital Radiographic System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2726-2026·2026-07-22
GE Medical Optima XR200/220/240amx Mobile Radiographic Systems Recall
GE HealthCare recalls certain Optima XR200/220/240amx mobile radiographic systems where safety testing may have been incomplete after column replacement. A failed counterpoise cable could cause the X-ray arm to drop on patients.
Product
Optima XR200amx, Mobile Digital-Ready Radiographic System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2725-2026·2026-07-22
Rapid Refill Continuous Injection System Recalled for Syringe Loosening Risk
Boston Scientific's Rapid Refill Continuous Injection System (UPN M00566001) is being recalled because the recalled Medline Namic Angiographic Control Syringe may loosen or disconnect from the manifold, potentially causing leakage, inability to aspirate or inject, and procedure delays.
Product
Rapid Refill Continuous Injection System, UPN M00566001
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2727-2026·2026-07-22
GE Optima XR200/220/240amx Radiographic System Column Safety Mechanism
GE Medical Systems is recalling certain Optima XR200/220/240amx mobile radiographic systems after column replacements because functional testing of the safety pawl may not have been performed, which could allow the X-ray arm to drop and injure patients.
Product
Optima XR220amx, Mobile Digital-Ready Radiographic System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2718-2026·2026-07-22
Olympus Toomey Evacuator 30cc medical device sterilization parameters recalled
Olympus Corporation recalled the Toomey Evacuator 30cc with Adaptor (Model 188) because certain sterilization parameters in the instructions may not consistently render the devices adequately sterile.
Product
Olympus Toomey Evacuator 30cc with Adaptor. Model Number: 188.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2721-2026·2026-07-22
Olympus Glass Body for 194 Ellik Evacuator Model 190A Sterilization Recall
Olympus Corporation is recalling the Glass Body for 194 Ellik Evacuator (Model 190A) because certain sterilization parameters in the instructions may not consistently render the devices adequately sterile.
Product
Olympus Glass Body for 194 Ellik Evacuator. Model Number: 190A.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2734-2026·2026-07-22
Papablic Replacement Brush Heads Recalled Due to Breakage Risk
Papablic Inc is recalling Papablic Replacement Brush Heads (Model PAPA317AA) due to potential for brush heads to break. The recall affects approximately 13,400 packs distributed nationwide.
Product
Papablic Replacement Brush Heads. Model Number: PAPA317AA.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2737-2026·2026-07-22
Medline Kits with Zimmer Biomet Mixing Bowls and Spatulas Recalled
Medline Industries is recalling 163 kits containing Zimmer Biomet mixing bowls and spatulas due to seal defects that risk sterility breach during surgical procedures.
Product
Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK-LF DYNJ61651J
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2743-2026·2026-07-22
Photera 600 Phototherapy Device UV Sensor Calibration Error
Daavlin Distributing Company is recalling 26 Photera 600 phototherapy devices nationwide because the UV sensor gain calibration is incorrect, causing inaccurate ultraviolet output readings.
Product
Photera 600, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2744-2026·2026-07-22
Photera 600 3-D phototherapy device UV sensor calibration error recall
Daavlin Distributing Company is recalling Photera 600 3-D phototherapy devices because the UV sensor gain calculation is incorrect, causing inaccurate ultraviolet output measurement.
Product
Photera 600 3-D, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2729-2026·2026-07-22
Orthofix MINIRAIL external fixation devices recalled for incorrect model labeling
Orthofix U.S. LLC is recalling Orthofix MINIRAIL external fixation devices (Model M101) because they may be labeled with incorrect model numbers, potentially leading to use of wrong device specifications.
Product
Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral orthopedic/trauma external fixation device
Category
Medical Device
Distribution
26 states
ModerateFDA (Devices)·Z-2731-2026·2026-07-22
Orthofix Articulated Minirail Fixator devices recalled for incorrect labeling
Orthofix U.S. LLC is recalling Articulated Minirail Fixator external fixation devices due to incorrect model labeling. Three models were mislabeled: M101 labeled as M103, M103 labeled as M101, and M122 labeled as M111.
Product
Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral orthopedic/trauma external fixation device
Category
Medical Device
Distribution
26 states
ModerateFDA (Devices)·Z-2732-2026·2026-07-22
Orthofix MINIRAIL External Fixation Devices Incorrectly Labeled
Orthofix MINIRAIL unilateral external fixation devices may be labeled with incorrect model numbers. Three model variants (M101, M103, M122) were mislabeled during manufacturing.
Product
Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral orthopedic/trauma external fixation device
Category
Medical Device
Distribution
26 states
ModerateFDA (Devices)·Z-2736-2026·2026-07-22
Medline Kits with Zimmer Biomet Mixing Bowls Recalled for Seal Defects
Medline is recalling 163 kits containing Zimmer Biomet mixing bowls and spatulas due to seal nonconformities that may compromise sterility. The defect could require extended surgery time to locate an alternative device.
Product
Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK DYNJT6267
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2742-2026·2026-07-22
Photera 400 Phototherapy Device Recalled for Incorrect UV Sensor Calibration
Daavlin Distributing Company is recalling the Photera 400 phototherapy device because the UV sensor calibration is calculating incorrectly, resulting in lower output levels than intended.
Product
Photera 400, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2722-2026·2026-07-22
da Vinci SP Instrument Arm Drape may detach during surgical procedures
Intuitive Surgical is recalling da Vinci SP Instrument Arm Drapes because the drape rings may detach, exposing the instrument arm and potentially delaying procedures. The recall affects 11,113 units distributed worldwide.
Product
da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2733-2026·2026-07-22
Papablic Replacement Brush Heads Recalled for Potential Breakage
Papablic Inc is recalling certain Papablic18B replacement brush head packs because the brush heads may break during use.
Product
Papablic Replacement Brush Heads. Model Number: Papablic18B
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2746-2026·2026-07-22
Tosoh ST AIA-Pack Testosterone Diagnostic Test Kit Recall
Tosoh Bioscience is recalling ST AIA-Pack Testosterone test kits due to low-quality control results that could produce falsely elevated or falsely low testosterone measurements, potentially leading to unnecessary testing or delayed diagnosis.
Product
ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific Tosoh AIA System analyzers, Model Number 0025204
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2740-2026·2026-07-22
Rio II Nasal Pillows Interface Packaging and Labeling Discrepancy Recall
3B Medical, Inc. is recalling Rio II Nasal Pillows Interface devices due to packaging and labeling discrepancies involving product size identification and device identifiers. The affected models are RII1001 (Small), RII1002 (Medium), and RII1003 (Large).
Product
Brand Name: Rio" II Product Name: Rio" II Nasal Pillows Interface Model/Catalog Number: RII1001 (Small), RII1002 (Medium), RII1003 (Large) Software Version: N/A Product Description: Nasal pillows interface intended for use with positive airway pressure therapy devices. The de
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2712-2026·2026-07-15
Elekta Geneva Brachytherapy Applicator Intrauterine Tube Detachment Risk
Elekta is recalling the Geneva Brachytherapy Applicator due to a safety concern that the tip of the intrauterine tube may detach and remain inside a patient during cancer treatment.
Product
Brand Name: Geneva Product Name: Brachytherapy Applicator Product Description: The device is intended for intracavitary brachytherapy for cancer treatment of the cervix and the endometrium. Optional needles can be placed for interstitial therapy.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2710-2026·2026-07-15
Fletcher CT/MR Shielded Applicator Set for Gynecological Brachytherapy Recalled
Elekta's Fletcher CT/MR Shielded Applicator Set is recalled due to risk that the tip of the intrauterine tube may detach and remain inside a patient during gynecological brachytherapy treatment.
Product
Brand Name: Fletcher CT/MR Shielded Applicator Set Product Name: Intracavitary Remote Afterloading Applicator Product Description: The Fletcher CT/MR Shielded Applicator Set is intended for gynecological brachytherapy treatment of the cervix and endometrium.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2716-2026·2026-07-15
TMINI Tracking Array knob loosening causing potential array misalignment
Think Surgical is recalling TMINI Femur and Tibia Tracking Arrays used in knee replacement surgery because the knob on the tracking array may loosen, causing potential misalignment of the array.
Product
TMINI Femur Tracking Array REF 109003 UDI-DI code: M9461090030 TMINI Tibia Tracking Array REF 109004 UDI-DI code: M9461090040 TMINI Miniature Robotic System is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2711-2026·2026-07-15
Brachytherapy Applicator Advanced Gynecological Applicator Tip Detachment
Elekta, Inc. is recalling Advanced Gynecological Applicators due to potential detachment of the intrauterine tube tip, which may remain inside a patient during cancer treatment.
Product
Brand Name: Brachytherapy Applicator Product Name: Advanced Gynecological Applicator Product Description: The intended use of the Advanced Gynecological Applicator is intracavitary brachytherapy for cancer treatment of the cervix and endometrium. Optional needles can be placed
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2694-2026·2026-07-15
Intracept Access Instruments sterile barrier breach risk
Boston Scientific is recalling Intracept Access Instruments due to potential sterile barrier breach in the outer tray seal, which could introduce infection risk.
Product
Intracept Access Instruments, Description/REF: INTRACEPT ACCESS INSTRUMENTS- DRILL/RLV0035, INTRACEPT ACCESS INSTRUMENTS- DRILL EU/RLV0035-EU, INTRACEPT ACCESS INSTRUMENTS- 2VB/RLV0045, INTRACEPT ACCESS INSTRUMENTS- 2VB EU/RLV0045-EU, INTRACEPT ACCESS INSTRUMENTS- 3VB/RLV005
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2698-2026·2026-07-15
MiniMed 780G Insulin Pump Software Anomaly Recall
Medtronic MiniMed's 780G Insulin Pump can stop delivering insulin due to a software anomaly when paired with the Instinct sensor, potentially leading to delayed therapy and increased risk of hyperglycemia or diabetic ketoacidosis.
Product
MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896
Category
Medical Device
Distribution
0 states

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