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 the agency’s own highest classification or reported deaths or serious injuries, 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

25251–25275 of 40357

SevereFDA (Devices)·Z-0343-2018·2018-01-31
Vyaire Medical Recalls Infant AirLife Humidification Chambers Due to Overflow Risk
Vyaire Medical is recalling 16,670 Infant AirLife single-limb circuits and humidification chambers because a manufacturing error may cause water to back up into the patient's airway.
Product
Infant AirLife single-limb, continuous-flow circuit (Model AH132) containing AirLife Humidification Chamber, Model Number AH290. The AH290 Humidification Chamber and Heated Breathing Circuit Kit(s) operate as part of a system for delivering health and humidified respirator…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0344-2018·2018-01-31
Vyaire Medical Recalls Infant AirLife Humidification Chamber Due to Overflow Risk
Vyaire Medical is recalling 16,670 Infant AirLife humidification chambers because a manufacturing error may cause water to overflow into the patient's airway.
Product
Infant AirLife Dual-,limb, dual-heat, high-flow circuit (Model AH265) with AirLife Humidification Chamber, Model Number AH290. The AH290 Humidification Chamber and Heated Breathing Circuit Kit(s) operate as part of a system for delivering health and humidified respirator…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0345-2018·2018-01-31
Vyaire Medical Recalls Adult Air-Life Single-Limb Circuits Due to Overflow Risk
Vyaire Medical is recalling 16,670 units of Adult Air-Life single-limb circuits with Humidification Chambers due to a manufacturing error that may cause water overflow into patient airways.
Product
Adult Air-Life single-limb circuit (Model AH202) with AirLife Humidification Chamber, Model Number AH290. The AH290 Humidification Chamber and Heated Breathing Circuit Kit(s) operate as part of a system for delivering health and humidified respirator gasses to patients…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0346-2018·2018-01-31
Vyaire Medical Recalls AirLife Humidification Chambers Due to Overflow Risk
Vyaire Medical is recalling 16,670 AirLife Humidification Chambers and circuits because a manufacturing error may cause water to back up into patient airways.
Product
Adult AirLife dual-limb, dual-heat circuit (Model AH280) with AirLife Humidification Chamber, Model Number AH290. The AH290 Humidification Chamber and Heated Breathing Circuit Kit(s) operate as part of a system for delivering health and humidified respirator gasses to…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0402-2018·2018-01-31
Philips Brilliance iCT CT Systems Recalled for Software Defects
Philips is recalling Brilliance iCT CT systems due to software issues affecting scan functions and safety features.
Product
Brilliance iCT SP - Model 728311 Brilliance iCT - Model 728306 Computed Tomography X-ray systems
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0411-2018·2018-01-31
Baxter Recalls MARS Treatment Kits Due to Albumin Circuit Leakage
Baxter Healthcare is recalling 186 MARS Treatment Kits because of a defect in the albumin circuit that causes leakage. The issue stems from an inadequate adhesive connection in the tubing.
Product
MARS Treatment Kit, Use only with MARS(R) Monitor 1TC, GAMBRO, Product Code 800541
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0410-2018·2018-01-31
Somatex TUMARK Q Medical Device Recalled for Sterility Risk
Somatex Medical Technologies is recalling TUMARK Q devices due to a potential risk of packaging puncture that could compromise sterility.
Product
TUMARK Q, Length 12 cm, Diameter 18G, GTIN 04250195603081, REF 271500, STERILE
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0405-2018·2018-01-31
Siemens Syngo Imaging PACS Recalled for Potential Data Loss
Siemens is recalling 36 units of Syngo Imaging version V31 software due to a potential risk of data loss relevant to diagnosis.
Product
Syngo Imaging version V31 (model # 10014063) is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images. It supports the physician in…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0407-2018·2018-01-31
Inovo CHAD Drive Oxygen Concentrators Recalled for Low Purity
Inovo, Inc. is recalling CHAD Drive oxygen concentrators because post-market surveillance found a high rate of low oxygen purity complaints.
Product
PURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000S
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0409-2018·2018-01-31
Smith & Nephew Taylor Spatial Frame Software Recalled for Image Inversion
Smith & Nephew is recalling Taylor Spatial Frame software versions 5.2.5 and 5.2.6 because the software may generate inverted images of the frame during strut adjustment planning.
Product
Smith & Nephew Taylor Spatial Frame Website software, Catalog Number 71070401. A web-based and mobile application software component of a multilateral external fixation system that is intended for fracture fixation, fixation of long bones and for joint fusions and limb…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0399-2018·2018-01-31
Medtronic MyCareLink Patient Monitors Recalled for Remote Monitoring Issues
Medtronic is recalling MyCareLink Patient Monitors because patients with multiple implanted heart devices may experience missed remote monitoring notifications.
Product
MyCareLink Patient Monitors. It is intended for used with a compatible Medtronic patient implanted heart device. The monitor is an external electronic device that interfaces with Medtronic implanted heart devices and a telecommunications connection to transmit stored…
Category
Medical Device
Distribution
11 states
HighFDA (Devices)·Z-0401-2018·2018-01-31
Sorin CP5 Centrifugal Pump Recalled for Delayed Air Bubble Detection Response
Sorin Group is recalling CP5 Centrifugal Pumps because the automatic line closure after air bubble detection may take longer than intended.
Product
CP5 Centrifugal Pump, made up of the drive unit, the emergency system and the pump control panel. It used with an Electrical Remote-Controlled (ERC) tubing clamp and a bubble sensor.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0403-2018·2018-01-31
Philips Brilliance iCT CT Systems Recalled for Software Defects
Philips Medical Systems is recalling 559 Brilliance iCT CT systems due to software issues affecting scan functions and safety features.
Product
Brilliance iCT - Model 728306 Computed Tomography X-ray systems
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0400-2018·2018-01-31
Medtronic MyCareLink Smart Patient Monitors Recalled for Remote Monitoring Issues
Medtronic is recalling MyCareLink Smart Patient Monitors because patients with multiple implanted heart devices may experience missed remote monitoring alerts.
Product
MyCareLink Smart Patient Monitors. It is intended for use with a compatible Medtronic patient implanted heart device. The reader is a portable electronic device that communicates with an implanted heart device
Category
Medical Device
Distribution
11 states
ModerateFDA (Devices)·Z-0394-2018·2018-01-31
BD MAX Vaginal Panel Recalled for Unresolved and Indeterminate Results
Becton Dickinson is recalling BD MAX CT/GC/TV kits due to increased rates of unresolved and indeterminate results, which may require repeat testing.
Product
BD MAX" CT/GC/TV. Catalog Number(s): 443824,442970,443590 (RUO).for collection and transport of vaginal and endocervical swab specimens, in addition to the preservation of urine from males and females.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0396-2018·2018-01-31
Smith & Nephew Mini-Fragment Plating System Recalled for Labeling Error
Smith & Nephew is recalling two units of bone plates due to incorrect labeling of the plate type.
Product
smith&nephew Mini-Fragment Plating System, VLP(R) Mini-Mod Small Bone Plating System, EVOS(R) Mini Plating system, 2.0MM STRAIGHT PLATE, 8 HOLE VLP(R) MIN-MOD, REF 74442024, QTY: (1), STERILE R Bone plates and bone screws from the Smith & Nephew Variable-Angle Locking…
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-0397-2018·2018-01-31
Smith & Nephew Recalls Mislabeled Mini-Fragment Bone Plating System Devices
Smith & Nephew is recalling two units of bone plates and screws that were incorrectly labeled as one model but contained a different model.
Product
smith&nephew Mini-Fragment Plating System, VLP(R) Mini-Mod Small Bone Plating System, EVOS(R) Mini Plating system, 2.0MM STOUT STRAIGHT PLATE, 8 HOLE VLP(R) MIN-MOD, REF 74442030, QTY: (1), STERILE R Bone plates and bone screws from the Smith & Nephew Variable-Angle Locking…
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-0393-2018·2018-01-31
BD MAX UVE Specimen Collection Kit Recalled for Test Result Issues
Becton Dickinson is recalling the BD MAX UVE Specimen Collection Kit because it may cause unresolved or indeterminate test results, potentially requiring re-testing.
Product
BD MAX" UVE Specimen Collection Kit. Catalog Number(s): 443376 for collection and transport of vaginal and endocervical swab specimens, in addition to the preservation of urine from males and females.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0392-2018·2018-01-31
BD MAX Vaginal Panel Recalled for Unresolved and Indeterminate Test Results
Becton Dickinson is recalling the BD MAX Vaginal Panel due to an increased rate of unresolved and indeterminate results, which may require repeat testing.
Product
BD MAXTM Vaginal Panel. Catalog Number(s): 443712 443710 443711 (RUO)for collection and transport of vaginal and endocervical swab specimens, in addition to the preservation of urine from males and females.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0404-2018·2018-01-31
Intuitive Surgical Recalls da Vinci Xi EndoWrist Stapler 45 Instruments
Intuitive Surgical is recalling 60 da Vinci Xi EndoWrist Stapler 45 instruments due to a manufacturing variation that may prevent the release wrench from unclamping the device.
Product
daVinci X EndoWrist(R) Stapler 45, REF 470298 Product Usage: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads, and other Stapler Accessories (including the bladeless obturators) are intended to be used with the da Vinci Surgical System (Model IS4000) for…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0406-2018·2018-01-31
Smith & Nephew Recalls Radial Osteotome Blades Due to Incorrect Expiration Dates
Smith & Nephew is recalling nine Radial Osteotome Blades because the expiration dates on the labels are incorrect. The devices were distributed in the US and Australia.
Product
Radial Osteotome Blade, REF 71369314. Used for cutting or preparing bone.
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-0395-2018·2018-01-31
Measurement Specialties Reusable Temperature Probes Recalled for Unvalidated Sterilization Instructions
Measurement Specialties Inc. is recalling 6,076 reusable temperature probes because their sterilization instructions have not been proven through a validation study.
Product
Measurement Specialties Reusable Temperature Probe Autoclavable. Sold as Esophageal/Rectal (Adult), Esophageal/Rectal (Pediatric), and Skin (Adult) Intended for use by a licensed physician to continuously monitor human esophageal, rectal, or skin temperature. They are…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0408-2018·2018-01-31
Smith & Nephew Recalls EVOS Flex Plates Due to Packaging Error
Smith & Nephew is recalling 12 units of EVOS 2.4MM Flex Plates because the packaging contained templates. The recall covers distribution to Oregon and Colombia.
Product
smith&nephew, 2.4 MM, 6 HOLE, EVOS, FLEX PLATE, SST Plate, REF CATALOG NUMBER 72442360N, NON-STERILE, Rx only, (01)00885556456446(10), (11)171116 Bone plates and bone screws from the EVOS Mini-Fragment Plating System are intended for use in internal fixation of small bones…
Category
Medical Device
Distribution
1 state
LowFDA (Devices)·Z-0398-2018·2018-01-31
Anspach Effort Recalls Oscillating Saw Attachment Due to Shipping Error
The Anspach Effort, Inc. is voluntarily recalling one oscillating saw attachment because it was mistakenly shipped to a non-veterinary customer.
Product
OSCILLATING SAW ATTACHMENT Surgical instrument motors and accessories/attachments are intended for use during surgical procedures to cut hard tissue or bone and soft tissue.
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0380-2018·2018-01-24
RayStation 6 Proton QA Module Recall for Potential Dosage Errors
RaySearch Laboratories is recalling RayStation 6 software due to a defect in the proton QA module that may result in incorrect patient dosage calculations.
Product
RayStation Product Usage: is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to…
Category
Medical Device
Distribution
Distributed nationwide

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