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

37976–38000 of 40449

ModerateFDA (Devices)·Z-1802-2013·2013-07-31
Becton Dickinson Recalls BBE Anaerobe Agar Due to Reduced Vancomycin
Becton Dickinson is recalling BBE Anaerobe Laked Sheep Blood Agar plates because they may contain reduced levels of Vancomycin.
Product
BD BBL BBE // CDC Anaerobe Laked Sheep Blood Agar with KV, packaged in cartons of 100 plates, Catalog # 297260, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Bacteroides Bile Esculin Agar (BBE) is…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1801-2013·2013-07-31
Becton Dickinson Recalls Anaerobe Agar Plates Due to Reduced Vancomycin Levels
Becton Dickinson is recalling specific lots of BD BBL Anaerobe CNA Agar plates because they may contain reduced levels of Vancomycin, potentially affecting test accuracy.
Product
BD BBL Anaerobe CNA Agar with 5% Sheep Blood // Anaerobe Laked Sheep Blood KV Agar, packaged in cartons of 20 plates, Catalog # 297041, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Anaerobe Laked…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1804-2013·2013-07-31
Becton Dickinson Recalls BCYE Selective Agar Plates Due to Reduced Vancomycin
Becton Dickinson is recalling 163 cartons of BCYE Selective Agar with PAV because the media may exhibit reduced levels of Vancomycin.
Product
BD BBL BCYE Selective Agar with PAV, Catalog # 297880, packaged in cartons of 10 plates, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** BCYE Selective with PAV is used in qualitative procedures for…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1805-2013·2013-07-31
Becton Dickinson Recalls BBL Campylobacter CSM Agar Due to Reduced Vancomycin
Becton Dickinson is recalling BBL Campylobacter CSM Agar because the media may exhibit reduced levels of Vancomycin.
Product
BBL Campylobacter CSM Agar (Charcoal-Based Selective Medium), Catalog # 299614, packaged in cartons of 20 plates, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** BCYE Selective with PAV is used in…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1800-2013·2013-07-31
Becton Dickinson Recalls CDC Anaerobe Agar Plates Due to Reduced Vancomycin
Becton Dickinson is recalling specific lots of CDC Anaerobe Agar plates because they may contain reduced levels of Vancomycin.
Product
BD BBL CDC Anaerobe 5% Sheep Blood Agar with Kanamycin and Vancomycin (KV), packaged in cartons of 100 plates, Catalog # 221736, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** CDC Anaerobe 5% Sheep…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1808-2013·2013-07-31
Stryker Neuroform 3 Stent System Recalled for Labeling Mismatch
Stryker Neurovascular is recalling 23 units of the Neuroform 3 Microdelivery Stent System because the model numbers on the outer carton and inner pouch labels do not match.
Product
Stryker brand Neuroform 3 Microdelivery Stent System, 4.5 mm X 20 mm, REF Catalog Number: E345020, Model/Product Number: M003450200, Product is manufactured by Boston Scientific Corporation, Fremont, CA and distributed by Stryker Neurovascular, Fremont, CA The Neuroform…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1799-2013·2013-07-31
Becton Dickinson Recalls Schaedler K-V Agar Plates Due to Reduced Vancomycin
Becton Dickinson is recalling specific lots of Schaedler K-V Agar plates because they may contain reduced levels of Vancomycin, potentially affecting test accuracy.
Product
BD BBL Schaedler K-V Agar with 5% Sheep Blood, carton of 20 plates, catalog # 221555, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Vancomycin Screen Agar is used to test entercocci for resistance to…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1784-2013·2013-07-31
Instrumentation Laboratory Recalls HemosIL RecombiPlasTin 2G Coagulation Reagent
Instrumentation Laboratory is recalling HemosIL RecombiPlasTin 2G reagent kits due to out-of-specification quality issues. The product is used for evaluating the extrinsic coagulation pathway.
Product
HemosIL RecombiPlasTin 2G, Part Number 0020002950 (8 ml size). The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1803-2013·2013-07-31
Becton Dickinson Recalls Brucella Laked Blood Agar Due to Reduced Vancomycin
Becton Dickinson is recalling specific lots of Brucella Laked Blood Agar because the media may contain reduced levels of Vancomycin.
Product
BBL Brucella Laked Blood Agar with Kanamycin and Vancomycin (KV), Catalog # 297840, packaged in cartons of 20 plates, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Brucella Laked Blood with KV is used for…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1796-2013·2013-07-31
Haemonetics Recalls TEG 5000 Analyzers Due to Manual Errors
Haemonetics is recalling 1,590 TEG 5000 Thromboelastograph Coagulation Analyzers because the user manual incorrectly included Research Use Only parameters.
Product
TEG 5000 Thromboelastograph Coagulation Analyzer Product Usage: Multipurpose System for In Vitro Coagulation Studies
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1782-2013·2013-07-31
Siemens ARTIS zee and zeego X-ray Systems Recalled for Software Issue
Siemens is recalling 29 ARTIS zee and zeego x-ray systems due to a software issue affecting rotational 3D-acquisition programs with real-time subtraction.
Product
ARTIS zee and zeego x-ray, angiographic system with Software Artis VC20x/VC21A that have Patch 7 and a 3D and DSA license installed. Angiographic x-ray system
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1771-2013·2013-07-31
Spacelabs ARKON Anesthesia Workstation Recalled for Software Defect
Del Mar Reynolds Medical is recalling nine Spacelabs ARKON Anesthesia Workstations due to a software defect that may cause false communication error alerts.
Product
Spacelabs ARKON Anesthesia Workstation. Spacelabs ARKON Anesthesia Workstation may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the…
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1806-2013·2013-07-31
Aesculap ProSpace PEEK Spinal Implant Recalled for Incorrect Etching
Aesculap is recalling nine ProSpace PEEK spinal implants because they are incorrectly etched with an 8-degree lordosis instead of the labeled 5-degree lordosis.
Product
ProSpace Peek Implant 5 degree x 8.5 x 22 mm The device is intended for vertebral body replacement or intervertebral body fusion to aid in the surgical correction or stabilization of the spine. The Aesculap PEEK Spinal Implant System is indicated for use in the thoracolumbar…
Category
Medical Device
Distribution
2 states
LowFDA (Devices)·Z-1778-2013·2013-07-31
National Biological Dermalight 80 UVB Phototherapy Units Recalled for Incorrect Manual
National Biological Corp is recalling Dermalight 80 UVB phototherapy units because they may have been packaged with the manual for a different UVA-083 device.
Product
Dermalight 80 Model Number UVB-080, one unit per box. The Dermalight 80 is a Phototherapy light unit that provides ultraviolet radiation therapy for diagnosed skin disorders such as Psoriasis and Vitiligo.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1810-2013·2013-07-31
Medtronic Preimplantation Test Kit Recalled for Incorrect Expiration Dates
Medtronic Neurosurgery is recalling Preimplantation Test Kits because the outer carton expiration dates are later than the dates on the individual sterile components.
Product
Medtronic Preimplantation Test Kit, Catalog No. 21047. The kit is indicated for use with Medtronic CSF-Flow Control Valves and Delta Valves, when a simple preimplantation test is desired to verify that the valve conforms to labeled product specifications.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1779-2013·2013-07-31
National Biological Dermalight 80 UVB Phototherapy Units Recalled for Incorrect Manual
National Biological Corp is recalling six Dermalight 80 UVB phototherapy units because they may have been packaged with the manual for a different UVA-080 device.
Product
Dermalight 80 Model Number UVB-083, one unit per box. The Dermalight 80 is a Phototherapy light unit that provides ultraviolet radiation therapy for diagnosed skin disorders such as Psoriasis and Vitiligo.
Category
Medical Device
Distribution
4 states
CriticalFDA (Devices)·Z-1691-2013·2013-07-24
Codman MedStream Infusion Pump Recalled for Miscalibrated Fill Level Sensor
Codman & Shurtleff is recalling MedStream Programmable Infusion Pumps because a miscalibrated fill level sensor may affect dosing levels.
Product
MedStream Programmable Infusion Pump , Implantable for the intrathecal delivery of Baclofen or Morphine Product Code: 91-4201US (40ml pump) 91-4201 (40ml pump) Intended for the intrathecal delivery of Baclofen or Morphine.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1690-2013·2013-07-24
Codman MedStream Infusion Pump Recalled for Miscalibrated Fill Level Sensor
Codman & Shurtleff is recalling MedStream Programmable Infusion Pumps because a miscalibrated fill level sensor may affect dosing levels.
Product
MedStream Programmable Infusion Pump- Implantable for the intrathecal delivery of Baclofen or Morphine Product Code:91-4200 (20ml pump) US 91-4200. Intended for the intrathecal delivery of Baclofen or Morphine.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1738-2013·2013-07-24
St. Jude Medical Recalls Eon Spinal Cord Stimulator Charging Systems
St. Jude Medical is recalling Eon and Eon Mini charging systems due to reports of skin burns and discomfort at the implant site during use.
Product
Eon - 3701 (Wall Charger) and 3711 (Portable Charger). Product Usage: Eon: Eon system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1753-2013·2013-07-24
Liebel-Flarsheim Hydra Vision DR 60/80 System Recalled for High Dosage
Liebel-Flarsheim is recalling 12 Hydra Vision DR 60/80 systems because a service call found the maximum fluoroscopy dose was three times the safety limit.
Product
Hydra Vision DR 60/80 System, Models 700539 and 700540, Liebel-Flarshiem Company. The System is used in radiologic imaging procedures.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1739-2013·2013-07-24
St. Jude Medical Recalls Eon Mini Spinal Cord Stimulator Chargers
St. Jude Medical is recalling Eon Mini chargers due to reports of skin burns and discomfort at the implant site during charging.
Product
Eon Mini - 3721 (Charger). Product Usage: Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1736-2013·2013-07-24
Integra PANTA Arthrodesis Nail System Recalled for Screw Misalignment
Integra LifeSciences is recalling PANTA Arthrodesis Nail Systems due to screw misalignment that may require revision surgery.
Product
Integra PANTA Arthrodesis Nail System. Intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1733-2013·2013-07-24
Terumo Recalls CDI 500 Blood Parameter Monitoring System Due to Software Error
Terumo is recalling 3,972 CDI 500 Blood Parameter Monitoring Systems because a software algorithm inaccuracy was discovered during internal testing.
Product
CDI Blood Parameter Monitoring System 500 with Arterial blood parameter module. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1746-2013·2013-07-24
Staar Surgical Recalls Intraocular Lenses Due to Glass Particles
Staar Surgical is recalling nanoFLEX and Afinity intraocular lenses because glass particles may be present in the storage vials.
Product
nanoFLEX CC4204A Intraocular Lens Correct aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by cataract extraction. The IOL is to be implanted in the posterior chamber and in the capsular bag through a tearfree capsulorhexis.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1747-2013·2013-07-24
Staar Surgical Recalls Intraocular Lenses Due to Glass Particles
Staar Surgical is recalling specific Afinity and nanoFLEX intraocular lenses because glass particles may be present in the storage vials.
Product
Afinity CQ2015A Intraocular Lens The visual correction of aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by cataract extraction.
Category
Medical Device
Distribution
Distributed nationwide

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37976–38000 of 40449