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

28951–28975 of 40325

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
ModerateFDA (Devices)·Z-2861-2016·2016-09-28
Abbott Recalls TECNIS Intraocular Lenses Due to Mislabeled Units
Abbott Medical Optics is recalling 217 TECNIS 1-Piece Intraocular Lenses because they were not checked prior to release, potentially resulting in mislabeled products.
Product
TECNIS 1-Piece IOL with the TECNIS iTec Preloaded Delivery System, Model No. PCB00 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…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2875-2016·2016-09-28
Pentax Video Bronchoscopes Recalled for Incorrect Operation and Reprocessing Instructions
Pentax of America Inc. is recalling 1,719 video bronchoscopes because they contain an incorrect Operation and Reprocessing IFUS.
Product
Pentax Video Bronchoscope Designed to be used with a Pentax Video Processor (including light source), documentation equipment, video monitor, endo-therapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2843-2016·2016-09-28
OrthoPediatrics Recalls Mislabeled 3.5mm Bowed Locking Compression Femur Plates
OrthoPediatrics Corp is voluntarily recalling 41 units of 3.5mm Bowed Locking Compression Femur Plates due to mislabeling.
Product
3.5mm Bowed Locking Compression Femur Plates, 14 hole Orthopediatrics PediLoc Locking Plate System comes in sets that offer the advantage of both conventional and locking plate fixation devices and instrumentation in one system. Utilizing both locking and non- locking screws…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2858-2016·2016-09-28
Abbott Recalls Mislabeled Intraocular Lenses Due to Quality Control Failure
Abbott Medical Optics is recalling 65 units of TECNIS 1-Piece Intraocular Lenses because they were not checked prior to release, potentially resulting in mislabeled products.
Product
TECNIS 1-Piece IOL, Model No. ZCB00 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-2838-2016·2016-09-28
Anspach Effort Recalls G1 Dissection Tools Due to Labeling Error
The Anspach Effort, Inc. is recalling 88 G1 Dissection Tools because product codes were inadvertently left off Hold 1503.
Product
G1 Dissection Tool - 3mm CRS DBALL, 2mm SHAFT EXP, M; For cutting and shaping bone including spine and cranium.
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2840-2016·2016-09-28
Anspach Effort Recalls G1 Dissection Tools Due to Labeling Error
The Anspach Effort, Inc. is recalling 69 G1 Dissection Tools because product codes were inadvertently left off Hold 1503.
Product
G1 Dissection Tool - 6MM CRS DBALL, 2mm Shaft EXP, M; For cutting and shaping bone including spine and cranium.
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2835-2016·2016-09-28
Ortho Solutions Recalls Mislabeled 35mm Non-Locking Orthopedic Screws
Ortho Solutions Inc is recalling 15 units of FPS 35mm x 3.5 mm non-locking screws due to mislabeling of a locking screw batch.
Product
FPS 35mm x 3.5 mm non-locking screw
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2846-2016·2016-09-28
Carefusion Recalls Pediatric Oxygen Delivery Modules Due to Incorrect Airway Size
Carefusion 2200 Inc is recalling Broselow/Hinkle Pediatric Emergency System Oxygen Delivery Modules because they contain an 8 cm airway instead of the labeled 5 cm size.
Product
Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, PINK/RED Oxygen Delivery Module 2/PACK, Product Code 7700RAW2
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-2873-2016·2016-09-28
Hospira LifeCare PCA Infusion System Recalled for Screw Rotation Error
Hospira Inc. is recalling 8,794 LifeCare PCA Infusion Systems because a screw rotation error can cause the pump to alarm and stop infusion.
Product
LifeCare PCA Infusion System with Hospira MedNet Software, PCA Serial List Number 20709 Allows for clinician administration or self-administration of analgesic medications.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2854-2016·2016-09-28
EKOS Intelligent Drug Delivery Catheter Recalled for Potential Epoxy Defect
EKOS Corporation is recalling 10 Intelligent Drug Delivery Catheters due to potential non-compliant manufacturing tests that may cause epoxy blisters.
Product
EkoSonic Endovascular Devices EKOS Intelligent Drug Delivery Catheter
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2864-2016·2016-09-28
Abbott Recalls Mislabeled Intraocular Lenses Due to Quality Control Failure
Abbott Medical Optics is recalling 41 intraocular lenses because they were not checked prior to release, potentially resulting in mislabeled products.
Product
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model No. Z9002 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…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2837-2016·2016-09-28
Anspach Effort Recalls G1 Dissection Tools Due to Release Error
The Anspach Effort, Inc. is recalling 177 G1 Dissection Tools because they were inadvertently released from hold status and distributed.
Product
G1 Dissection Tool - 7mm FBALL L; For cutting and shaping bone including spine and cranium.
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2836-2016·2016-09-28
SybronEndo Recalls Sealapex Xpress Root Canal Resin Due to Labeling Error
SybronEndo is recalling 179 units of Sealapex Xpress root canal filling resin because the product was labeled with an incorrect expiration date.
Product
Sealapex Xpress, Part No. 33639 The brand name of the device is Sealapex Xpress, a root canal filling resin. Sealapex Xpress is intended to be used during endodontic therapy to fill the root canal of a tooth.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2865-2016·2016-09-28
Merge Cardio software recall for missing patient information on report pages
Merge Healthcare is recalling Merge Cardio software version 10.1 because patient information is missing from subsequent report pages.
Product
Merge Cardio software. Product Usage: Merge Cardio is an integrated cardiovascular information system classified as a picture archiving and communications system.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2844-2016·2016-09-28
OrthoPediatrics Recalls Mislabeled 3.5mm Bowed Locking Compression Femur Plates
OrthoPediatrics Corp is voluntarily recalling 41 units of 3.5mm Bowed Locking Compression Femur Plates due to mislabeling. The devices were distributed nationwide to specific states.
Product
3.5mm Bowed Locking Compression Femur Plates, 18 hole Orthopediatrics PediLoc Locking Plate System comes in sets that offer the advantage of both conventional and locking plate fixation devices and instrumentation in one system. Utilizing both locking and non- locking screws…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2863-2016·2016-09-28
Abbott Recalls 41 Intraocular Lenses Due to Mislabeled Product Risk
Abbott Medical Optics is recalling 41 TECNIS Multifocal Intraocular Lenses because they were not checked prior to release, posing a risk of mislabeling.
Product
TECNIS Multifocal Foldable Acrylic Intraocular Lens, Model No. ZMA00 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
LowFDA (Devices)·Z-2845-2016·2016-09-28
Biomet 3i Recalls 92 Dental Implants Due to Packaging Error
Biomet 3i is recalling 92 units of 3I Osseotite dental implants because they were incorrectly packaged. The affected units were distributed in the US and several international countries.
Product
3I OSSEOTITE CERTAIN DENTAL IMPLANTS, 4x11.5 mm, Sterile, Rx only.
Category
Medical Device
Distribution
2 states
LowFDA (Devices)·Z-2851-2016·2016-09-28
CooperSurgical Recalls Sage CSC Thawing Medium Due to Incorrect Package Insert
CooperSurgical, Inc. is recalling 4 units of Sage CSC Thawing Medium because the products contain an international package insert instead of the correct USA package insert.
Product
Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Thawing Medium Product Number: ART-8018 Intended for use in freezing embryos. This product is intended for thawing of embryos frozen with ART-8017, CSC Freezing Medium. This kit is designed to be used in…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2850-2016·2016-09-28
Sage CSC Freezing Medium Recalled for Incorrect USA Package Insert
CooperSurgical is recalling Sage CSC Freezing Medium because it shipped with an international package insert instead of the correct USA version.
Product
Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Freezing Medium . Product Number: ART -8017 SAGE In Vitro Fertilization, Inc. A CooperSurgical Company 95 Corporate Drive Trumbull, CT 06611 USA
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2790-2016·2016-09-21
Hospira MedNet Software Recall for Incorrect Bolus Calculations
Hospira is recalling MedNet 6.1 software used with SapphirePlus infusion pumps because it may calculate incorrect bolus amounts for drugs in Million Units.
Product
Hospira MedNet Medication Management Suite software, version 6.1, List Numbers 16037-64-02 and 16037-64-03, in combination with the SapphirePlus 13.1x infusion pump Hospira MedNet Medication Management Suite is intended to facilitate networked communication between compatible…
Category
Medical Device
Distribution
13 states

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28951–28975 of 40325