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

33851–33875 of 40449

HighFDA (Devices)·Z-0836-2015·2014-12-31
Ion Beam Applications Recalls adaPT insight Software Due to Calibration Error
Ion Beam Applications S.A. is recalling one unit of adaPT insight software in Pennsylvania due to a calibration file error and a gantry collision incident.
Product
adaPT insight (12C), v1.3.2, PAT.109 (US), Treatment room 4: I2C is used with a charged particle or photon radiation therapy system for localization of the patient position with respect to the therapy equipment and to provide correction feedback to the radiation therapy device.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0853-2015·2014-12-31
Zimmer Recalls Persona Cemented Tibial Broach Inserter/Extractor Handles
Zimmer, Inc. is recalling 83 units of Persona Cemented Tibial Broach Inserter/Extractor Handles because the magnet cover may disassociate and be lost during surgery.
Product
Persona Cemented Tibial Broach Inserter/Extractor. The Persona Cemented Tibial Broach Inserter/Extractor Handle is a Use sterilizable instrument intended for use In multiple TKA procedures. The Persona Surgical Technique indicates that the Persona Cemented Tibial Broach…
Category
Medical Device
Distribution
12 states
HighFDA (Devices)·Z-0873-2015·2014-12-31
Radiometer HemoCue Glucose 201 Microcuvettes Recalled for Discoloration and Inaccurate Results
Radiometer America Inc. is recalling HemoCue Glucose 201 Microcuvettes because they show discoloration and provide results outside specification near the end of their shelf life.
Product
HemoCue¿ Glucose 201 Microcuvettes, The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201Analyzer and the HemoCue Glucose 201 DM Analyzer (hereafter referred to as the HemoCue Glucose 201 Analyzer). HemoCue Glucose 201 Microcuvettes are…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0862-2015·2014-12-31
Bausch & Lomb Stellaris PC Laser Recall for Software Anomaly
Bausch & Lomb is recalling 106 Stellaris PC laser systems because a software anomaly may cause the device to automatically transition from Standby to Ready to Fire during surgery.
Product
Bausch & Lomb Stellaris PC w/ Laser, BL14304 The responsible firm name is Bausch & Lomb Incorporated Rochester, NY
Category
Medical Device
Distribution
21 states
HighFDA (Devices)·Z-0832-2015·2014-12-31
Instrumentation Laboratory Recalls HemosIL PT-Fibrinogen HS PLUS Reagent
Instrumentation Laboratory is recalling HemosIL PT-Fibrinogen HS PLUS reagent kits because some vials exhibit discoloration that causes prolonged prothrombin clotting times.
Product
HemosIL PT-Fibrinogen HS PLUS, IVD --- Instrumentation Laboratory IL Company. A high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the quantitative determination in human citrated plasma of Prothrombin Time (PT) and Fibrinogen on IL…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0864-2015·2014-12-31
Bausch & Lomb Stellaris PC Vision Enhancement System Recalled for Software Anomaly
Bausch & Lomb is recalling two Stellaris PC Vision Enhancement Systems because a software anomaly may cause the device to automatically transition from Standby to Ready to Fire during surgery.
Product
Bausch & Lomb Stellaris PC w/ Laser Upgrade BL14334 (Stellaris PC w v4 Software) with BL2272 (Laser Upgrade kit) Stellaris PC Vision Enhancement System with integrated laser module. System is used for the surgical treatment/removal of cataractous lens, vitreous removal and…
Category
Medical Device
Distribution
21 states
ModerateFDA (Devices)·Z-0839-2015·2014-12-31
Unapproved Dental Implants Recalled by Instradent USA
Instradent USA is recalling 13 units of Neodent Titamax WS Cortical Implants because the product is not approved for use in the US.
Product
Neodent Titamax WS Cortical Implant ¿4.0 x 5 mm (Endosseous dental implant) Article Number: 109.604 Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0861-2015·2014-12-31
US Endoscopy Recalls UroSeal Valves Due to Sterile Seal Integrity Issues
US Endoscopy Group Inc is recalling 100 units of UroSeal Adjustable Endoscopic Valves because the sterile pouch seals may not be intact.
Product
UroSeal Adjustable Endoscopic Valve. Model/Catalog # 00913410 The primary packaging is a Tyvek pouch. The secondary package is a corrugate box. 5 units per box. Used to cover the opening to the biopsy/suction channel of an endoscope.
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-0849-2015·2014-12-31
Illumina MiSeqDx Universal Kit 1.0 Recalled for Software Limitation
Illumina Inc is recalling 13 units of the MiSeqDx Universal Kit 1.0 because a software limitation prevents the reporting of specific genomic insertions and deletions.
Product
Illumina MiSeqDx Universal Kit 1.0, PN 15039608 The Illumina MiSeqDx Universal Kit 1.0 is a set of reagents and consumables used in the processing of human genomic DNA samples derived from peripheral whole blood, and in the subsequent targeted sequencing of the resulting…
Category
Medical Device
Distribution
5 states
ModerateFDA (Devices)·Z-0870-2015·2014-12-31
Maquet Pediatric Oxygenator Recalled for Incorrect Coating Labels on Packaging
Maquet is recalling 28 units of Quadrox-ID Pediatric Diffusion Membrane Oxygenators because the cartons and shipping containers incorrectly display Softline coating labels instead of Bioline.
Product
Maquet Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coating; Part Number BEQ-HMOD-30000 For cardiac surgery in combination with a heart lung machine to oxygenate blood, remove carbon dioxide and adjust blood temperature.
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-0847-2015·2014-12-31
Natus neoBLUE 2 Phototherapy LED Kit Recalled for Higher Light Intensity
Natus Medical is recalling replacement LED PCB kits for neoBLUE 2 phototherapy systems because they produce higher light intensity than the original device.
Product
Replacement LED PCB Kit, part number 001840, of the Natus neoBLUE (aka neoBLUE 2) Phototherapy system. Neonatal phototherapy.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0851-2015·2014-12-31
Zimmer NexGen Knee Implant Drill Guide Recalled for Fit Issues
Zimmer Trabecular Metal Technology is recalling 8 units of NexGen Complete Knee Solution drill guides because two units did not fit the handle during cleaning.
Product
NexGen Complete Knee Solution Monoblock Tibial Provisional / Drill Guide Tibial Size 5 Femoral Size Green / CH Zimmer U.K. Ltd., SN3 4FP, UK Zimmer Trabecular Metal Technology, Inc 10 Pomeroy Road, Parsippany, NJ 07054 USA
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0838-2015·2014-12-31
Siemens Dimension Vista Lab Systems Recalled for Reagent Performance Issues
Siemens Healthcare Diagnostics is recalling Dimension Vista 500 and 1500 systems due to reagent probe performance decline that may affect patient and QC results.
Product
Dimension Vista 500 Intelligent Lab System or Dimension Vista 1500 Intelligent Lab System: An in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0871-2015·2014-12-31
Baxter Recalls Self-Righting Luer Tip Caps Due to Validation Timing
Baxter Corporation is recalling two lots of sterile syringe tip caps because they were distributed before the completion of a required validation process.
Product
Self-Righting Luer Lock Tip Cap, Green and Self-Righting Luer Slip Tip Cap, Yellow, Baxter Healthcare Corporation, 14445 Grasslands Dr. Englewood, CO 80112 USA. DISCPAC Syringe Tip Caps. RER H93866100 x 1000. Sterile
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0855-2015·2014-12-31
Unistrip Technologies Recalls Blood Glucose Test Strips for Labeling Changes
Unistrip Technologies LLC is recalling 7,175 units of UniStrip1 Blood Glucose Test Strips because the company failed to submit a 510(k) for device labeling changes.
Product
UniStrip1, Blood Glucose Test Strips, 50 count box. The test strips are indicated for use by people with diabetes in their home as an aid to monitor the effectiveness of diabetes control.
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-0875-2015·2014-12-31
Zimmer Recalls Trilogy Fiber Metal Acetabular Shell Due to Thread Defect
Zimmer Manufacturing B.V. is recalling 68 units of Trilogy Fiber Metal Acetabular Shells because the polar-hole threads were found to be undersized, preventing proper attachment to surgical instruments.
Product
Trilogy¿ Fiber Metal Acetabular Shell Size 54 mm OD The Trilogy Acetabular System is indicated for either cemented or uncemented use in skeletally mature individuals undergoing primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0843-2015·2014-12-31
Advanced Sterilization Products Recalls STERRAD 100S Cassettes for Leak Indicator Defect
Advanced Sterilization Products is recalling STERRAD 100S cassettes because the leak indicator on the packaging may not function properly after exposure to hydrogen peroxide.
Product
STERRAD 100S, Product Code 10113. The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0842-2015·2014-12-31
Advanced Sterilization Products Recalls STERRAD 50 Cassettes Due to Leak Indicator Defect
Advanced Sterilization Products is recalling STERRAD 50 cassettes because the leak indicator on the packaging may not function properly after exposure to hydrogen peroxide.
Product
STERRAD 50, Product Code 10114. The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0852-2015·2014-12-31
Getinge 46-Series Medical Washer-Disinfector Recalled for Sediment Residuals
Getinge Disinfection AB is recalling 46-Series Medical Washer-Disinfector models 46-4 and 46-5 due to sediment residuals in the manifold caused by air pockets.
Product
GETINGE 46-SERIES Medical Washer-Disinfector, Models 46-4 and 46-5, with PACS 300/350 Control Series with dryer --- Class II, exempt from 510(k) requirements. For use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0834-2015·2014-12-31
Intuitive Surgical Recalls Fluorescence Imaging Procedure Kits for Missing Storage Info
Intuitive Surgical is recalling Fluorescence Imaging Procedure Kits because storage conditions for indocyanine green are missing from the packaging.
Product
Fluorescence Imaging Procedure Kit, designed for use with Firefly Fluorescence Imaging for the da Vinci Si 3000 Surgical Systems. The Intuitive Surgical Endoscopic Instrument Control System (Intuitive Surgical da Vinci Surgical System Model IS3000) is intended to assist in the…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0835-2015·2014-12-31
Intuitive Surgical Recalls Fluorescence Imaging Procedure Kits for Missing Storage Info
Intuitive Surgical is recalling Fluorescence Imaging Procedure Kits because storage conditions for indocyanine green are missing from the packaging.
Product
Fluorescence Imaging Procedure Kit, designed for use with Firefly Fluorescence Imaging for the da Vinci Xi 4000 Surgical Systems. The Intuitive Surgical Endoscopic Instrument Control System (Intuitive Surgical da Vinci Surgical System Model IS3000) is intended to assist in the…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0833-2015·2014-12-31
GE Healthcare Recalls Centricity Enterprise Archive Software Due to Data Loss Risk
GE Healthcare is recalling Centricity Enterprise Archive software versions 4.0.x due to a potential data loss issue associated with HL-7 updates.
Product
Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data. DICOM devices (e..g. modalities, workstations) Communicate with the archive using the DICOM protocol (published by ACR-NEMA). The clinical use is limited to the interaction…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0860-2015·2014-12-31
Siemens ADVIA Centaur XP Immunoassay System Recalled for Tubing Crack Risk
Siemens Healthcare Diagnostics is recalling 10,515 ADVIA Centaur XP Immunoassay Systems because a slight crack may occur in the tubing at the reservoir connector assembly due to mechanical stress.
Product
ADVIA Centaur XP Immunoassay System (including refurbished) Professional use in a laboratory for in vitro diagnostic tests.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0845-2015·2014-12-31
Advanced Sterilization Products Recalls STERRAD System Cassettes Due to Leak Indicator Defect
Advanced Sterilization Products is recalling STERRAD System cassettes because the leak indicator on the packaging may not function properly after exposure to hydrogen peroxide.
Product
STERRAD NX, Product Code 10133 The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0844-2015·2014-12-31
Advanced Sterilization Products Recalls STERRAD 200 Cassettes Due to Leak Indicator Defect
Advanced Sterilization Products is recalling STERRAD 200 cassettes because the leak indicator on the packaging may not function properly after exposure to hydrogen peroxide.
Product
STERRAD 200, Product Code 10118 The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
Category
Medical Device
Distribution
0 states

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33851–33875 of 40449