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

28926–28950 of 40357

ModerateFDA (Devices)·Z-2897-2016·2016-10-05
Prismatik Recalls BruxZir Shaded Dental Restorations Due to Quarantine Failure
Prismatik Dentalcraft is recalling 150 units of BruxZir Shaded dental restorations because the manufacturer failed to properly identify quarantined lots as such.
Product
BruxZir Shaded, Model No. 70-1167-NOW0001, 70-1167-NOW0002, 70-1167-NOW0003, 70-1167-NOW0005, 70-1167-NOW0006 The device is indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior location.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2887-2016·2016-10-05
R&D Systems Recalls Quantikine IVD sTfR Immunoassay Kits Due to Control Issues
R&D Systems is recalling 725 Quantikine IVD sTfR Immunoassay Kits because internal testing confirmed that control results were out of range high.
Product
R&D Systems, Quantikine¿ IVD¿sTfR Immunoassay Kit, for the quantitative determination of soluble transferrin receptor (sTfR) concentrations in human serum and plasma For in Vitro Diagnostic Use, REF DTFR1.
Category
Medical Device
Distribution
12 states
ModerateFDA (Devices)·Z-2889-2016·2016-10-05
Ethicon Mersilene Tape Recalled for Incorrect Instructions for Use Insert
Ethicon, Inc. is recalling Mersilene Tape products because certain product codes were supplied with an incorrect Instructions for Use (IFU) insert.
Product
ETHICON MERSILENE" Tape (also referred to as MERSILENETM Polyester Fiber Strip or MERSILENETM Fiber Ligature)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2874-2016·2016-09-28
Hospira LifeCare PCA 3 Pumps Recalled for Screw Rotation Error
Hospira is recalling 69 LifeCare PCA 3 pumps due to a screw rotation error that stops infusion and triggers an alarm.
Product
LifeCare PCA 3, PCA Serial List Number 12384 Allows for clinician administration or self-administration of analgesic medications.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2848-2016·2016-09-28
Smith & Nephew Recalls Renasys Sterile Transparent Film Due to Seal Failures
Smith & Nephew is recalling Renasys Sterile Transparent Film and related dressing kits because sterility seal integrity failures may compromise the sterile barrier.
Product
RENASYS Sterile Transparent Film and all the RENASYS Dressing kits that contains the RENASYS Sterile Transparent Film Is intended for patients who would benefit from a suction device (negative pressure) to help promote wound healing by removing fluids including irrigation and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2849-2016·2016-09-28
TriMed Recalls Semi-Tubular Plates Due to Screw Failure During Implantation
Trimed Inc is recalling 30 units of SMTP-10 Semi-Tubular Plates because a non-locking screw passed through a plate hole during implantation.
Product
TriMed Semi-Tubular Plate, 10-Hole, Model No. SMTP-10 Contoured plate with offset screw holes. The plate is 103 mm in length, 1.3 mm thick and 9.6 mm wide. The part is made of surgical steel conformance with ASTM F138 or F139. The plate is used to fixation of long bone…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2871-2016·2016-09-28
Merge Healthcare Recalls CADstream MRI Software Due to Grid Selection Error
Merge Healthcare is recalling CADstream software versions 4.1.3 and prior because an incorrect grid selection could lead to an incorrect biopsy or missed target during MRI analysis.
Product
CADstream software. Product Usage: CADstream is an image processing system designed to assist in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) studies. CADstream also is intended to provide workflow efficiency and interventional planning…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2866-2016·2016-09-28
Sorin S5 Heart-Lung Machine Recalled for Power Supply Failure Risk
Sorin Group USA is recalling 5,264 Stöckert S5 Heart-Lung Machines worldwide due to a potential failure of the Uninterruptible Power Supply.
Product
St¿ckert S5 System, S5 Heart-lung machine, Cardiopulmonary bypass heart-lung machine console Product Usage: The St¿ckert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less. These devices come in direct contact with the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2870-2016·2016-09-28
Global Healthcare Recalls VacuFlow Safe Blood Collection Sets
Global Healthcare Inc is recalling 282 cartons of VacuFlow Safe blood collection sets because the needle sheath may not fully retract.
Product
MED 5223 - VacuFlow Safe, Multi-Sample Blood Collection Set With Luer Adapter Tube 12", Sterile, Rx only, Distributed by Tanner Scientific, Sarasota, FGL 34243 Made in China.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2842-2016·2016-09-28
Philips HeartStart MRx Monitor/Defibrillator Recall for Handle Separation
Philips is recalling 394 HeartStart MRx Monitor/Defibrillators because the handle can separate from the housing due to broken mounts.
Product
HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2839-2016·2016-09-28
Anspach Effort G1 Dissection Tool Recall for Missing Product Codes
The Anspach Effort, Inc. is recalling 63 G1 Dissection Tools because several product codes were inadvertently left off of Hold 1503.
Product
G1 Dissection Tool - 3mm FLUTED BALL; For cutting and shaping bone including spine and cranium.
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2855-2016·2016-09-28
Abbott Recalls SENSAR Intraocular Lenses Due to Mislabeled Units
Abbott Medical Optics is recalling 84 SENSAR Foldable Intraocular Lenses because they were not checked prior to release, which may result in the release of mislabeled units.
Product
SENSAR Foldable IOL with OptiEdge Design, Model No. AR40e The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2847-2016·2016-09-28
Broselow Pediatric Emergency System Pouches Recalled for Incorrect Airway Size
Carefusion 2200 Inc is recalling Broselow Pediatric Emergency System pouches because the PINK/RED Oxygen Delivery Module contains an 8 cm airway instead of the labeled 5 cm size.
Product
Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, Broselow Complete Set of Colored Pouches, Product Code 7730MOD
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-2867-2016·2016-09-28
Invivo Recalls Philips Expression IP5 MRI Patient Monitoring Units
Invivo Corporation is recalling 639 Philips Expression Information Portal (IP5) units because display numerics may freeze and menu keys may disable after extended run time.
Product
Philips Expression Information Portal (IP5) Model 865471. The IP5 is intended to be used as a secondary display control unit for the Expression MRI Patient Monitoring System and the Expression MR200 MRI Patient Monitoring System.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2872-2016·2016-09-28
McKesson Radiology Software Recalled for Missing STAT Priority Icon
McKesson Medical Imaging Group is recalling McKesson Radiology software versions 12.1.1 and 12.2 because the STAT priority icon was not displayed in the Study List when a study was opened.
Product
McKesson Radiology, versions 12.1.1 and 12.2 McKesson Radiology (MR) is a Picture Archiving Communication System (PACS). It is a medical image and information management application that is intended to receive, transmit, store, retrieve, display, print and process digital…
Category
Medical Device
Distribution
40 states
ModerateFDA (Devices)·Z-2859-2016·2016-09-28
Abbott Recalls Intraocular Lenses Due to Mislabeled Product Release
Abbott Medical Optics is recalling 131 TECNIS OptiBlue intraocular lenses because they were not checked prior to release, potentially resulting in mislabeled products.
Product
TECNIS OptiBlue 1-Piece Intraocular Lens (IOL), Model No. ZCB00V The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2857-2016·2016-09-28
Abbott Recalls TECNIS Symfony Intraocular Lenses Due to Mislabeled Units
Abbott Medical Optics is recalling 10 TECNIS Symfony intraocular lenses because they were not checked prior to release, potentially resulting in mislabeled products.
Product
TECNIS Symfony Extended Range of Vision IOL, Model No. ZXR00 The product is indicated primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by extracapsular cataract extraction, and…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2860-2016·2016-09-28
Abbott Recalls SENSAR Intraocular Lenses Due to Mislabeled Units
Abbott Medical Optics is recalling SENSAR 1-Piece Intraocular Lenses because they were not checked prior to release, which may result in the release of mislabeled units.
Product
SENSAR 1-Piece IOL, Model No. AAB00 The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2868-2016·2016-09-28
Integra Recalls Spinal Tray Kits Missing Needle Introducer
Integra LifeSciences is recalling 320 packages of Spinal Tray 24G Gertie Marx kits because one lot was shipped without the required needle introducer.
Product
PHS Spinal Tray 24G Gertie Marx, Catalogue No. 899379. Intended to provide licensed medical professionals with a kit containing drugs and other medical devices that are used to support the administration of general, local anesthetics.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-2852-2016·2016-09-28
Siemens Syngo.x Software Recalled for Incorrect Volume Calculations
Siemens Medical Solutions is recalling 338 Syngo.x PACS systems because a software error caused volume calculations for prostate and liver to be too high.
Product
Syngo.x picture archiving and communication system Syngo.x is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2862-2016·2016-09-28
Abbott Recalls Intraocular Lenses Due to Mislabeled Units
Abbott Medical Optics is recalling 70 units of TECNIS OptiBlue Intraocular Lenses because they were not checked prior to release, potentially resulting in mislabeled products.
Product
TECNIS OptiBlue 1-Piece IOL with the TECNIS iTec Preloaded Delivery System, Model No. PCB00V The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2856-2016·2016-09-28
Abbott Recalls TECNIS Multifocal Intraocular Lenses Due to Mislabeled Units
Abbott Medical Optics is recalling 77 TECNIS Multifocal Intraocular Lenses because they were not checked prior to release, potentially resulting in mislabeled products.
Product
TECNIS Multifocal 1-Piece Intraocular Lens, Model No. ZKB00, ZLB00; The product is indicated for primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by extracapsular cataract…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2869-2016·2016-09-28
Hologic Sertera Biopsy Device Recalled for Incorrect Labeling
Hologic is recalling 570 units of the Sertera Biopsy Device due to incorrect labeling on the sterile kit.
Product
Sertera Biopsy Device, Sterile; Used primarily in ultrasound-guided breast biopsies.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2853-2016·2016-09-28
Siemens Syngo.via Software Recalled for Incorrect Volume Calculations
Siemens Medical Solutions is recalling 338 Syngo.via systems because a software error caused volume calculations for prostate and liver to be too high.
Product
Syngo.via picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2841-2016·2016-09-28
Siemens IGF-I Reagent Recalled for Incubation Time Defect
Siemens Healthcare Diagnostics is recalling IGF-I reagents because the required incubation time for pretreatment solution equilibration is 24 minutes, not as previously indicated.
Product
IG1, IGF-I reagent, Catalog # LKGF1; For the quantitative measurement of insulin-like growth factor I (IGF-I) in serum or heparinized plasma.
Category
Medical Device
Distribution
7 states

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28926–28950 of 40357