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

27426–27450 of 27681

HighFDA (Devices)·Z-2177-2012·2012-08-15
Terumo Advanced Perfusion System 1 Recall for Module Malfunctions
Terumo is recalling 992 Advanced Perfusion System 1 units due to faulty components in the Occluder and Air Bubble Detection modules.
Product
System 1 base 100/120V The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2173-2012·2012-08-15
Siemens syngo Lab Data Manager Recall for Incorrect Coagulation Results
Siemens is recalling 15 syngo Lab Data Manager units because they may display and transmit incorrect coagulation results to laboratory information systems.
Product
Siemens syngo(R) Lab Data Manager. The syngo(R) Lab Data Manager is classified as a data calculator and processing module for use with In-vitro diagnostic devices. It also provides work flow management as well as remote instrument control to multiple interfaced instruments
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2150-2012·2012-08-15
Finapres Portapres Blood Pressure Monitor Recalled for Battery Safety
Finapres Medical Systems is recalling three Portapres blood pressure monitors in the US because the NiMh battery pack may become hot and leak.
Product
Finapres Medical Systems Portapres with NiMh battery pack Product Usage: Continuously measure blood pressure, The Portapres can be worn on the body with a protective waist belt. The device can be used without mains; in that case a battery pack is used.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2176-2012·2012-08-15
Stryker Spine Recalls Reliance AL Implant Blocker Due to Prong Breakage
Stryker Spine is recalling Reliance AL Implant Blockers because six reports indicated that prongs on the instruments broke during use.
Product
Stryker Reliance AL Implant Blocker (Various sizes) The SLIDE Implant Blocker is a reusable instrument, sterilized prior to use. It allows the surgeon to distract the disc space in the lumbar region of the spine using an anterior or anterolateral approach while also allowing…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2164-2012·2012-08-15
Radiometer ABL90 FLEX Software Recall for HL7 Data Transmission Errors
Radiometer America Inc. is recalling ABL90 FLEX software version 2.7 MR3 because a data transfer error can cause mixed-up results when transmitting to hospital systems.
Product
ABL90 FLEX software version 2.7 MR3. The ABL90 FLEX analyzer is intended for in vitro testing of samples of heparinized whole blood.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2170-2012·2012-08-15
Abbott i-Stat BNP Cartridges Recalled for Atmospheric Pressure Interference
Abbott Point of Care Inc. is recalling i-Stat BNP cartridges because atmospheric pressure can cause suppressed test results, potentially affecting heart failure diagnosis.
Product
i-Stat BNP cartridges Abbott Point of Care Inc. The i-Stat BNP test is an in vitro diagnostic test for the quantitative measurement of B-type Natriuretic Peptide (BNP) in whole blood or plasma samples using EDTA as the anticoagulant. BNP measurements can be used as an aid…
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-2181-2012·2012-08-15
Kimberly-Clark Patient Warming System Recalled for Fuse Holder Defect
Kimberly-Clark is recalling 129 Model 1000 Patient Warming System Control Units because a fuse holder defect may cause the device to fail or generate smoke.
Product
Kimberly Clark Patient Warming System - Model 1000 Control Unit. Kimberly Clark Patient Warming System - Model 1000 Control Unit and Energy Transfer Pads is a thermal regulating system, indicated for monitoring and controlling patient temperature.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2172-2012·2012-08-15
Siemens EasyLink Informatics System Recalled for Incorrect Diagnostic Results
Siemens Healthcare Diagnostics is recalling 237 EasyLink Informatics Systems because they may display and transmit incorrect results to Laboratory Information Systems when used with specific coagulation analyzers.
Product
EasyLink(TM) Informatics System, Part Number 1000034805. EasyLink(TM) Informatics System is classified as a data calculator and processing module for use with In-Vitro diagnostics devices.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2158-2012·2012-08-15
Biomet 3i Recalls Dental Implants Due to Shallow Internal Hex Depth
Biomet 3i is recalling specific dental implants because the internal hex depth is too shallow, which may prevent components from fully engaging the implant.
Product
***REF IFNT611***Full OSSEOTITE Tapered Certain Implant 6 x 11.5mm***Sterile by radiation***Rx Only***BIOMET 3i Dental Iberica S.L. WTC Almeda Park, Ed, 1, Planta 1 Pl. de la Pau s/n08940 Cornella de Llobregat (Barcelona) Spain. Lot #2011110798. Intended for surgical…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2171-2012·2012-08-15
Abbott i-Stat CK-MP Cartridges Recalled for Atmospheric Pressure Interference
Abbott Point of Care Inc. is recalling i-Stat CK-MP cartridges because atmospheric pressure can cause suppressed test results, potentially affecting the diagnosis of myocardial infarction.
Product
i-Stat CK-MP cartridges Abbott Point of Care Inc. The i-Stat CKMB test is an in vitro diagnostic test for the quantitative measurement of creatinine kinase MB mass in whole blood or plasma samples. CK-MB measurements can be used as an aid in the diagnosis and treatment of…
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-2157-2012·2012-08-15
Abbott i-STAT PT/INR Cartridges Recalled for Incorrectly Elevated Results
Abbott Point of Care Inc. is recalling i-STAT PT/INR cartridges because they may display incorrectly elevated results, potentially affecting monitoring of patients on anticoagulation therapy.
Product
I-STAT PT/INR cartridge Abbott Point of Care Inc. Abbott Park, IL 60064 USA This cartridge is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or warfarin.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2166-2012·2012-08-15
Smith & Nephew TWINFIX Ultra Ti Anchor Recall for Breakage Risk
Smith & Nephew is recalling 4,661 units of TWINFIX Ultra Ti Anchors because the distal part may break during insertion into bone.
Product
Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures(white, COBRAID-blue), sterile Part Number: 72202895 Product Usage: intended for use for the reattachment of soft tissue to bone
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2151-2012·2012-08-15
ConMed Linvatec Recalls PopLok Bone Punch Due to Incorrect Shaft Diameter
ConMed Linvatec recalled one lot of PopLok bone punches because the metal shaft diameter was 4.5mm instead of the intended 3.5mm.
Product
PopLok Punch labeled in part: "PKL-35M***3.5mm***QTY 1***PopLok Punch***ConMed Linvatec Biomaterials, Ltd. Hermiankatu 6-8L 33720 Tampere, FINLAND***Rx Only***ConMed Linvatec 11311 Concept Blvd Largo, FL 33773-4908 USA***Made in USA***" Intended Use: Bone Punch.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2178-2012·2012-08-15
Terumo Advanced Perfusion System 1 recalled for module malfunctions
Terumo is recalling 649 Advanced Perfusion System 1 units worldwide due to faulty components in the Occluder and Air Bubble Detection modules.
Product
System 1 base 220/240V The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2113-2012·2012-08-08
Sunrise Medical Recalls Padded Swing Away Arm Rests Due to Injury Reports
Sunrise Medical is recalling 14,035 Padded Swing Away Arm Rests for specific wheelchair models because reports indicate injury when the armrest is used to support full body weight.
Product
Padded Swing Away Arm Rest with Receiver; Uses on wheelchair models: Quickie Q7 (EIR4), GT (EIR3), GTi (EIT4) and Zippie Zone (EIRZ1). Product Usage: To empower physically challenged persons by providing a means of mobility. This includes temporary and permanent…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2107-2012·2012-08-08
Smiths Medical Medfusion 4000 Syringe Infusion Pump Software Recall
Smiths Medical is recalling Medfusion 4000 Syringe Infusion Pumps due to a software anomaly that causes device history log corruption and triggers a Watchdog Fail-Safe alarm.
Product
Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely…
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-2092-2012·2012-08-08
Zimmer Recalls Nextgen Knee Replacement Jaw Instruments Due to Fracture Risk
Zimmer Inc. is recalling Nextgen Complete Knee Solution replacement jaws because the spring clip may fracture or fall off during use, potentially leaving fragments in the surgical site.
Product
Nextgen Complete Knee Solution Replacement Jaw for Use with Femoral and Provisional Impactor/Extractor, REF 00-5901-026-40, Non-Sterile Zimmer, Warsaw Indiana The instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2091-2012·2012-08-08
Zimmer Recalls Nextgen Knee Instruments Due to Spring Clip Fracture Risk
Zimmer Inc. is recalling 1,662 Nextgen Complete Knee Solution Femoral and Provisional Impactor/Extractor instruments because the spring clip may fracture or fall off during use, potentially leaving fragments in the surgical site.
Product
Nextgen Complete Knee Solution Femoral and Provisional Impactor/ Extractor, REF 00-5901-026-00, Non-Sterile Zimmer, Warsaw Indiana The instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2128-2012·2012-08-08
ICU Medical Recalls High Pressure Stopcocks Due to Molding Defect
ICU Medical is recalling 4,625 High Pressure Stopcocks because a molding defect may cause side ports to become totally occluded.
Product
High Pressure Stopcock (3-Way, Luer Lock, Off). Product Usage: For IV.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2125-2012·2012-08-08
GE OEC Medical Systems Recalls OEC 9800 Plus Digital Imaging Systems
GE OEC Medical Systems is recalling OEC 9800 Plus Digital imaging systems due to a hard disk drive issue. The recall covers 82 units distributed worldwide.
Product
OEC 9800 Plus Digital; MDL number A349855. Product Usage: Is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include cholangiography, endoscopic, urologic, orthopedic…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2106-2012·2012-08-08
Intuitive Surgical Recalls Instrument Arm Drapes Due to Adaptor Engagement Issues
Intuitive Surgical is recalling specific lots of Instrument Arm Drapes because the sterile adaptor may have difficulty engaging an instrument during surgery.
Product
ACCESSORY BASE STARTER KIT,IS3000; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0859-2012·2012-08-08
Arm and Hammer Spinbrush Recall for Choking Hazard
Church & Dwight is recalling Spinbrush Pro Whitening toothbrushes due to a potential small parts choking hazard if used beyond the recommended 3-month brush head life.
Product
Arm and Hammer Spinbrush Dual Action Powered Toothbrush Spinbrush Pro Whitening Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal.
Category
Consumer Product
Distribution
0 states
HighFDA (Devices)·Z-2095-2012·2012-08-08
Church & Dwight Recalls Spinbrush Pro White Sonic Crest Toothbrushes
Church & Dwight is recalling Spinbrush Pro White Sonic Crest Powered Toothbrushes due to a potential small parts choking hazard if used beyond the recommended 3-month brush head life.
Product
Arm and Hammer Spinbrush Pro White Sonic Crest Powered Toothbrush Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal
Category
Consumer Product
Distribution
0 states
HighFDA (Devices)·Z-2102-2012·2012-08-08
Intuitive Surgical Recalls Specific Lots of da Vinci Instrument Arm Drapes
Intuitive Surgical is recalling specific lots of da Vinci Instrument Arm Drapes because the sterile adaptor may have difficulty engaging an instrument.
Product
KIT,DISPOSABLE ACCESSORY,3ARM,IS2000,5 PACK; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2094-2012·2012-08-08
Arm and Hammer Spinbrush Pro Clean Sonic Toothbrush Recall for Choking Hazard
Church & Dwight is recalling Arm and Hammer Spinbrush Pro Clean Sonic toothbrushes due to a small parts choking hazard if brush heads are used beyond their recommended life.
Product
Arm and Hammer Spinbrush Pro Clean Sonic Color Wear Powered Toothbrush Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal
Category
Consumer Product
Distribution
0 states

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