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

29676–29700 of 40449

ModerateFDA (Devices)·Z-2237-2016·2016-07-27
Nobel Biocare Dental Implants Recalled for Incorrect Top Label
Nobel Biocare is recalling 53 Replace Select Tapered dental implants due to incorrect top labels on the packaging. The recall covers units distributed in the US and internationally.
Product
Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105 Replace Select Tapered implants are root-form endosseous implants intended to be surgically placed in the bone of the upper and lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in…
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-2209-2016·2016-07-27
Terumo Recalls Sarns TCM II Heater-Cooler Units Due to Sanitizer Discontinuation
Terumo CVS is voluntarily recalling Sarns TCM II heater-cooler units because the Interchlor sanitizer referenced in cleaning instructions is no longer available.
Product
Sarns TCM II; The Sarns Temperature Control and Monitor unit (TCM) II (system) is a source of temperature controlled water for blood heat exchangers used in an extracorporeal circuit and for blankets to externally heat or cool the patient. It also freezes water for an ice…
Category
Medical Device
Distribution
51 states
ModerateFDA (Devices)·Z-2245-2016·2016-07-27
Siemens Syngo.via PACS Software Recalled for Incorrect Volume Calculations
Siemens Medical Solutions is recalling 50 units of Syngo.via PACS software due to incorrect volume calculation values. A software update is available to resolve the error.
Product
Syngo.via, picture archiving and communications system software controlled. Intended to be used for viewing, manipulation, communication, and storage of medical images.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2256-2016·2016-07-27
Siemens ADVIA Centaur XPT Software Recalled for Potential Result Errors
Siemens Healthcare Diagnostics is recalling ADVIA Centaur XPT system software versions V1.0.1 through V1.1 due to eight identified issues that may affect test results.
Product
ADVIA¿ Centaur XPT system software versions V1.0.1 (Bundle 1.0.912 SMN 10819704), V1.0.2 (Bundle 1.0.1086 SMN 11219806), V1.0.3 (Bundle 1.0.1108 SMN 11220781) and V1.1 (Bundle 1.1.243 SMN 11221979). Product Usage: This system is intended for professional use in a laboratory…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2210-2016·2016-07-27
Terumo Sarns Dual Cooler-Heater Recalled Due to Missing Sanitizer
Terumo CVS is voluntarily recalling Sarns Dual Cooler-Heater devices because the distributor no longer sells the Inter chlor sanitizer required for cleaning.
Product
Preamendments device-Sarns Dual Cooler-Heater. The Sarns Dual Cooler-Heater is a self-contained unit for supplying cold and warm water to heat exchangers during open heart surgery. It supplies water at a rate of up to 6.5 gallons per minute (25 liters per minute) at zero…
Category
Medical Device
Distribution
51 states
ModerateFDA (Devices)·Z-2252-2016·2016-07-27
BD Trucount Tubes Recalled for Potential Sealing Defects
Becton, Dickinson and Company is recalling one lot of BD Trucount Absolute Counting Tubes because they may not be sealed properly, which can degrade product performance.
Product
BD Trucount Tubes: Catalog number: 340334 Hematology: BD Trucount tubes are used for determining absolute counts of leucocytes in blood.
Category
Medical Device
Distribution
17 states
ModerateFDA (Devices)·Z-2225-2016·2016-07-27
WalkMed Recalls IV Administration Sets Due to Potential Particulate Presence
WalkMed Infusion is voluntarily recalling specific IV administration sets due to the potential presence of particulate matter in or on the devices.
Product
T090-000W 90" 20 Drop IV Admin Set w/2 Needlefree Y-Sites Back Check Valve. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2241-2016·2016-07-27
CSL Behring Recalls Dimension Vista Homocysteine Reagent Cartridges
CSL Behring is recalling 898 units of Dimension Vista Homocysteine Flex Reagent Cartridges because opened lots show reduced stability and do not meet the 7-day claim.
Product
Dimension Vista¿ Homocysteine Flex Reagent Cartridge (HCYS), Device Listing No.: D017878 is an in vitro diagnostic test for the quantitative measurement of total homocysteine in human serum, heparinized plasma and EDTA plasma on the Dimension Vista System.
Category
Medical Device
Distribution
36 states
ModerateFDA (Devices)·Z-2239-2016·2016-07-27
Hologic Recalls ATEC Suction Canisters Due to Cracked Lids
Hologic is recalling 16,870 ATEC Suction Canisters because the lids may crack. These devices are used to collect fluid during breast biopsies.
Product
ATEC CANISTER. Suction Canister with Lid 490 cc., RX Only; Suction canister used to collect fluid during a breast biopsy.
Category
Medical Device
Distribution
52 states
ModerateFDA (Devices)·Z-2220-2016·2016-07-27
WalkMed Infusion Pumps Recalled for Unapproved Software and Specification Changes
WalkMed Infusion is recalling Triton and Triton FP infusion pumps due to unapproved changes to software, specifications, and intended use.
Product
The pump (with cushioning foam inserts) is packaged in a single pump box. Four pump boxes are placed in an over-shipper for distribution.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2214-2016·2016-07-27
DePuy Synthes Recalls TFNA Blade/Screw Guide Sleeves Due to Sizing Defect
DePuy Synthes is voluntarily recalling TFNA Blade/Screw Guide Sleeves because a manufacturing defect may prevent proper use, potentially causing surgical delays.
Product
Depuy Synthes Trauma- Trochanteric Fixation Nail Advanced (TFNA) Blade/Screw Guide Sleeve, Surgical Instrument Part Number ID 03.037.017, Class I exempt Lot Numbers: 9066399; 9066435; 9409790; 9519308; 9620447; 9301183; 9409792; 9519303; 9641077; 9301184; 9409791; 9542998…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2188-2016·2016-07-27
Toshiba Angio WorkStation Recalled for Incorrect Skin Dose Calculation
Toshiba is recalling 23 Angio WorkStation systems because a software error caused the displayed Peak Skin Dose to be higher than expected during specific procedures.
Product
Toshiba America Medical Systems Angio WorkStation: XIDF-AWS801v6.00, v6.01, and V6.10 System: INFX-8000V Bi-Plane System
Category
Medical Device
Distribution
11 states
ModerateFDA (Devices)·Z-2208-2016·2016-07-27
Terumo Recalls Sarns Temperature Control Units Due to Sanitizer Discontinuation
Terumo CVS is voluntarily recalling Sarns TCM units because the Interchlor sanitizer referenced in cleaning instructions is no longer sold by the distributor.
Product
Sarns TCM; The Sarns Temperature Control and Monitor unit (TCM) is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and for blankets to externally heat or cool the patient The TCM with options will also supply water for…
Category
Medical Device
Distribution
51 states
CriticalFDA (Devices)·Z-1887-2016·2016-07-20
Heartware Ventricular Assist System Battery Recall for Premature Depletion
Heartware, Inc. is recalling 18,631 HeartWare Ventricular Assist System batteries due to premature depletion. The recall covers devices distributed nationwide in the US.
Product
HeartWare Ventricular Assist System: HeartWare Battery, Lithium Ion, 14.8 V, Rx only. Catalog 1650 (US) and 1650, 1650-DE and A00035 (OUS) Product Usage: Used as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2142-2016·2016-07-20
Hospira LifeCare Pump Model 4200 PCA Infuser Recalled for Occlusion Detection Failure
Hospira is recalling 6,268 LifeCare Pump Model 4200 PCA Infusers because they may fail to detect distal occlusions, a defect that caused one serious injury.
Product
The LifeCare Pump Model 4200 PCA Infuser makes possible the practical implementation of patient-controlled analgesia. The health care professional sets the prescribed dose, rates, and limits for the drug to be infused. The infuser can be set to operate in one of three modes: PCA…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2140-2016·2016-07-20
Hospira PCA 3 Infusion Pump Recall for Occlusion Detection Failure
Hospira is recalling 8,216 PCA 3 infusion pumps because normal wear on a component may prevent the device from detecting distal occlusions, a defect that resulted in one serious injury.
Product
The PCA 3 system cam be used in a wide range of clinical settings, including but not limited to: general floor, labor/delivery,post-partum, burn unit, medical surgical, operating room, oncology, critical care units, post-anesthesia care unit (PACU), and pediatrics. The PCA 3…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2139-2016·2016-07-20
Hospira Recalls LifeCare PCA Plus II Infusion Pumps Due to Occlusion Detection Failure
Hospira is recalling 53,151 LifeCare PCA Plus II infusion pumps because wear on a component may prevent the detection of distal occlusions, resulting in serious injury.
Product
The LifeCare PCA Plus II infusion pump system is designed for safe, effective, analgesic delivery to patients through the intravenous or epidural routes in a wide range of clinical settings, including ICU, CCU, SICU, trauma units, bone marrow transplant centers, burn units…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2141-2016·2016-07-20
Hospira Recalls LifeCare PCA Infusion Systems Due to Occlusion Detection Failure
Hospira is recalling 38,878 LifeCare PCA infusion systems because wear on a component may prevent the pump from detecting distal occlusions, a defect that has resulted in one serious injury.
Product
LifeCare PCA infusion system with Hospira MedNet software allows clinicians to administer, or patients to self-administer analgesia, safely and effectively within clinician programmed limits and/or hospital-defined medication limits. The LifeCare PCA infusion system is used in a…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2146-2016·2016-07-20
Hardy Diagnostics Recalls QuickSlide MGS-80 Gram Stainers Due to Discrepant Results
Hardy Diagnostics is recalling 25 QuickSlide MGS-80 and GramPRO-80 automated Gram stainers because they may produce discrepant culture and Gram stain results, potentially leading to misdiagnosis or improper patient treatment.
Product
QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80. Systematically stains, rinses, decolorizes, and counter-stains the provided biological sample and slide.
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-2149-2016·2016-07-20
Varian Optical Surface Monitoring System Recall for Unintended Couch Parameter Changes
Varian Medical Systems is recalling Optical Surface Monitoring Systems (OSMS) used with TrueBeam EDGE because unintended changes to couch rotation parameters can occur during patient set-up.
Product
Optical Surface Monitoring System{OSMS, Varian Private Label} This is used on Varian's TrueBeam EDGE; Radiology: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to Withhold the beam…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2147-2016·2016-07-20
Sorin Recalls Aortic Arch Cannulae Due to Incorrect Tip Angle
Sorin Group USA is recalling Aortic Arch Cannulae because the distal tip angle is 15-20 degrees instead of the specified 45 degrees.
Product
AORTIC ARCH CANNULA, Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (part numbers NA-55X7 and NA-55X8) Aortic Arch Cannulae are designed to be used in the extracorporeal circuit during cardiopulmonary bypass surgery. The cannula consists of varying lengths of…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2180-2016·2016-07-20
Stryker Target Detachable Coils Recalled for Manufacturing Defect
Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage to internal sutures may reduce stretch resistance, potentially leading to increased coil stretching.
Product
Target Detachable Coils: TARGET HELICAL NANO 2MM X 4CM MODEL Number:M0035452040 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2183-2016·2016-07-20
Stryker Target Detachable Coils Recalled for Manufacturing Defect
Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage to internal sutures may reduce stretch resistance, increasing the risk of coil stretching.
Product
Target Detachable Coils: TARGET HELICAL NANO 2.5MM X 4CM MODEL Number:M0035452540 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2166-2016·2016-07-20
Stryker Target Detachable Coils Recalled for Reduced Stretch Resistance
Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage may have reduced the stretch resistance of internal sutures, potentially causing the coils to stretch.
Product
Target Detachable Coils: TARGET HELICAL NANO 1 MM X 2 CM MODEL Number:M0035431020 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2151-2016·2016-07-20
Novarad NovaPACS Diagnostic Viewer Recall for Image Orientation Flipping
Novarad Corporation is recalling NovaPACS Diagnostic Viewer software versions 7.4, 7.5, 7.6, and 8.0 because images may flip during streaming, potentially displaying incorrect orientation markers.
Product
NovaPACS versions 7.4, 7.5, 7.6, and 8.0, Diagnostic Viewer. Distributed by Novarad Corporation. Picture archiving and communication system (PACS)
Category
Medical Device
Distribution
Distributed nationwide

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29676–29700 of 40449