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

35326–35350 of 40449

ModerateFDA (Devices)·Z-2150-2014·2014-08-13
Siemens ADVIA Centaur CP BNP Kit Recalled for Failed Calibration
Siemens Healthcare Diagnostics is recalling 961 BNP kits due to complaints of failed calibration. The kits are used for in vitro diagnostic testing of B-type Natriuretic Peptide.
Product
SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309045 - 500 test For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur CP System.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2143-2014·2014-08-13
Carestream Recalls Ultra-speed Dental Film Due to Indicator Dot Misalignment
Carestream Health Inc. is recalling 1,633 boxes of Ultra-speed Dental Film because the indicator dot is incorrectly positioned, which may cause image orientation errors.
Product
Ultra-speed Dental Film, Catalog Number/REF 834 8658, KODAK and Carestream DENTAL labels --- Carestream Health Inc.
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-2154-2014·2014-08-13
Teleflex Recalls RUSCH Foley Urinary Catheter Insertion Trays Due to Labeling Error
Teleflex Medical is recalling 720 RUSCH Foley Urinary Catheter Insertion Trays because the expiration date is incorrectly printed as the same as the manufacturing date.
Product
RUSCH Foley Urinary Catheter Insertion Tray with 10cc syringe, BZK Swabs, Sterile, Rx only, Teleflex Medical Product Code: 76730.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2142-2014·2014-08-13
Carestream Recalls INSIGHT Dental Film Due to Indicator Dot Misplacement
Carestream Health Inc. is recalling INSIGHT Dental Film because the indicator dot on the packaging is misaligned, which may cause dental practitioners to view images upside down.
Product
INSIGHT Dental Film, Catalog Number/REF 811 0785, KODAK and Carestream DENTAL labels --- Carestream Health Inc.
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2112-2014·2014-08-06
Wellspring Recalls IPM Wound Gel Rx Wound Dressing Due to Microbial Contamination
Wellspring Pharmaceutical is recalling IPM Wound Gel Rx Wound Dressing due to a potential for microbial contamination. The product is distributed in the US and Canada.
Product
IPM Wound Gel Rx Wound Dressing IPM Wound Gel is indicated for the management of wound healing.
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-2122-2014·2014-08-06
Stryker InTouch Critical Care Bed Recall Due to Caster Failure
Stryker is recalling InTouch Critical Care Beds because casters may break and fall off, potentially affecting brake functions.
Product
InTouch Critical Care Bed, Stryker Medical. Model Numbers 2130, 2131, 2140, 2141, 2151, 2152, 2155, and 2156.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2131-2014·2014-08-06
Zimmer Recalls 28 Distal Radial Volar Plates Due to Screw Locking Failure
Zimmer, Inc. is recalling 28 units of the Distal Radial Volar Plate Lateral Column because a defect prevented screws from locking, causing them to pull through the plate.
Product
Zimmer Periarticular Locking Plate System Distal Radial Volar Plate Lateral Column (1st generation stainless steel only). Orthopedic fixation plate. For temporary internal fixation and stabilization of osteotomies and fractures.
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2118-2014·2014-08-06
Medtronic Nexdrive Micropositioning Drive Recalled for Potential Misalignment
Medtronic is recalling Nexdrive Micropositioning Drives because a scale misalignment could cause microelectrodes to be inserted at incorrect depths during surgery.
Product
Medtronic Nexdrive Micropositioning Drive. Models Ml-1000 and Ml-2000. For use in conjunction with the Medtronic Nexframe Stereotactic System for the precise positioning of microelectrodes and implantable leads. A stereotactic guidance system used in conjunction with…
Category
Medical Device
Distribution
15 states
HighFDA (Devices)·Z-2123-2014·2014-08-06
Ra Medical Systems Recalls PHAROS EX-308 Excimer Lasers Due to Calibration Defect
Ra Medical Systems is recalling 435 PHAROS EX-308 Excimer Lasers because they may calibrate with the iris closed.
Product
PHAROS Excimer Laser, Model No. EX-308 UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis and leukoderma
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2130-2014·2014-08-06
Teleflex Recalls RUSCH TruLite Disposable Laryngoscope Handles
Teleflex Medical is recalling RUSCH TruLite laryngoscope handles because the handle may heat up and melt the end cap.
Product
RUSCH, TruLite, One-Piece Disposable Laryngoscope Handle Blade Combination, Non-Sterile, Rx Only, Distributed by: Teleflex Medical.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2126-2014·2014-08-06
Baxter Recalls FlowCOUPLER Implantable Devices for Potential Signal Loss
Baxter Healthcare is recalling 1,315 FlowCOUPLER implantable devices because some units may lose electrical continuity, preventing proper monitoring of blood flow.
Product
FlowCOUPLER. An implantable device that is used to detect blood flow in vessels. Used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The FlowCOUPLER System is intended to detect blood flow and…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2124-2014·2014-08-06
DeRoyal Knee Arthroscopy Pack Recalled Due to Component Recall
DeRoyal Industries is recalling 128 Knee Arthroscopy Packs because they contain Irrigation Sets previously recalled by Hospira.
Product
DeRoyal KNEE ARTHROSCOPY PACK, REF 89-6192.04, 1 Per Pack, Distributed by: DeRoyal Industries, Inc.; Manufacturer: DeRoyal Industries, Inc.
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2117-2014·2014-08-06
Dynarex CPR Shield Recalled for Incorrect Orientation Labeling
Dynarex Corporation is recalling CPR Shields with One Way Valves because the 'THIS SIDE UP' label is on the wrong side, posing a potential health hazard if misused.
Product
CPR Shield With One Way Valve and Barrier Filter, Reorder No. 4921 --- Dynarex label, 100 per case --- Manufactured for: Dynarex Corporation - Made in China. Used as a physical barrier for mouth to mouth resuscitation.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2121-2014·2014-08-06
McKesson Horizon Medical Imaging Software Recalled for Image Index Discrepancy
McKesson Medical Imaging is recalling Horizon Medical Imaging software due to a defect that may cause a mismatch between the expected image index and the actual folder content.
Product
Horizon Medical Imaging It is a medical image and information management application that is intended to receive, transmit, store, retrieve, display print and process digital medical images, digital medical video, and associated medical information from various medical…
Category
Medical Device
Distribution
48 states
ModerateFDA (Devices)·Z-2119-2014·2014-08-06
Teleflex Medical Recalls Emerald Fiberoptic Blades Due to Packaging Error
Teleflex Medical is recalling 120 units of Emerald Fiberoptic Blades because the boxes contained incorrect Miller 4 blades instead of the labeled Macintosh 4 blades.
Product
Emerald Fiberoptic Blade, Macintosh 4, Teleflex Medical. A rigid laryngoscope is a device used to examine and visualize a patient's upper airway and aid placement of a tracheal tube.
Category
Medical Device
Distribution
9 states
ModerateFDA (Devices)·Z-2125-2014·2014-08-06
DeRoyal Cardiac Hypothermia Tray Recalled Due to Contaminated Irrigation Sets
DeRoyal is recalling Cardiac Hypothermia Trays because they contained irrigation sets previously recalled by Hospira.
Product
DeRoyal Cardiac Hypothermia Tray, REF 50-9422.07, 1 Per Pack, Distributed by: DeRoyal Industries, Inc.; Made in Guatemala
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2132-2014·2014-08-06
Nidek MC-500 Laser Photocoagulator Recalled for Missing Aperture Label
Nidek Inc. is recalling 29 MC-500 Multicolor Laser Photocoagulators because the laser aperture label was not affixed to the devices prior to shipment.
Product
MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufactured by NIDEK CO., Ltd, Japan. For use in ophthalmic and retinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2134-2014·2014-08-06
Brainlab Patient Data Manager 2.0 Software Recall for Image Display Defects
Brainlab AG is recalling Patient Data Manager 2.0 software due to defects in transferring and displaying non-square pixel medical images.
Product
Patient Data Manager 2.0 (Content manager 2.0, Patient Browser 4.0, DICOM Viewer 2.0) Brainlab Digital Lightbox. A system for the display of medical images. Model numbers 25100-05 and 25100-06. The software can transfer images to and from picture archiving and…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2127-2014·2014-08-06
Small Bone Innovations Recalls AutoFIX Cannulated Compression Screw Systems for IFU Update
Small Bone Innovations is recalling 506 units of 3.0/4.0mm AutoFIX Cannulated Compression Screw Systems to update the Instructions for Use (IFU).
Product
Small Bone Innovations 3.0/4.0mm AutoFIX" Cannulated Compression Screw System Sets, Implants, and Instruments Indications for Use: AutoFIX" cannu lated screws are indicated for the treatment of fractures, non-unions, pseudoarthrosis and degenerative changes as well as…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2129-2014·2014-08-06
Septodont Recalls Compolite Bond SE Due to Incorrect Packaging
Septodont is recalling 24 units of Compolite Bond SE dental adhesive because the material was incorrectly packaged. The product was distributed to wholesalers in Pennsylvania and New York.
Product
Darby Dental Supply Compolite Bond SE Self-Etch/Light-Curing. This product is used to adhere restorative material to the tooth during restorations. Package contains 100 0.125 mL unit dose tips, 100 applicator brushes, and a product insert.
Category
Medical Device
Distribution
2 states
LowFDA (Devices)·Z-2133-2014·2014-08-06
Siemens Dimension Integrated Chemistry Systems Recalled for Photometer Misassembly
Siemens is recalling 15 Dimension Integrated Chemistry Systems due to a photometer misassembly issue that may shorten the life of the source lamp.
Product
Dimension¿ Integrated Chemistry Systems intended to measure a variety of analytes in human body fluids.
Category
Medical Device
Distribution
9 states
LowFDA (Devices)·Z-2128-2014·2014-08-06
Septodont Recalls Self-Etch Bond Adhesive Due to Packaging Error
Septodont is recalling Self-Etch bond adhesive because the material was incorrectly packaged. The recall involves 60 units distributed to two wholesalers in Pennsylvania and New York.
Product
Henry Schein Natural Elegance SE Bond Self-Etch Light-Cure Adhesive contains 50 0.125 mL unit dose tips, 50 applicator brushes, and a product insert.
Category
Medical Device
Distribution
2 states
SevereFDA (Devices)·Z-2068-2014·2014-07-30
GE Healthcare Recalls DateX-Ohmeda S/5 Airway Modules Due to CO2 Measurement Failure
GE Healthcare is recalling DateX-Ohmeda S/5 Single-Width Airway Modules and E-miniC accessories because a CO2 detector failure may cause incorrect low readings, potentially impairing clinical decision-making for ventilated patients.
Product
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2080-2014·2014-07-30
Stryker Recalls Disposable StrykeFlow Tips Due to Sterility Concerns
Stryker Endoscopy is recalling 496 boxes of Disposable StrykeFlow Tips because a deformed blister pouch could compromise the product's sterility.
Product
Disposable StrykeFlow Tip, Stryker Disposable Suction/I irrigator Tip; Sterile, Rx only, Latex Free. Stryker Suction Irrigation system, used to provide a clean and clear operative site through the evacuation and aspiration of irrigant solution. for endoscopic use.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2021-2014·2014-07-30
Blood Glucose Test Strips Recalled for Inappropriate Labeling and Marketing
Diabetic Supply of Suncoast, Inc. is recalling Advocate Redi-Code+ blood glucose test strips because they were inappropriately labeled and marketed.
Product
ADVOCATE Redi-Code+ BMB-BA006A Blood Glucose test strips Product Usage: The ADVOCATE¿ Redi-Code+ BMB-BA006A Blood Glucose test strips are used only with the ADVOCATE¿ Redi-Code+ BMB-EA004S meter to quantitatively measure glucose in fresh capillary whole blood samples drawn…
Category
Medical Device
Distribution
Distributed nationwide

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35326–35350 of 40449