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

35251–35275 of 40449

HighFDA (Devices)·Z-2183-2014·2014-08-20
Ortho-Clinical Diagnostics Recalls VITROS CA 19-9 Reagent Packs and Calibrators
Ortho-Clinical Diagnostics is recalling VITROS CA 19-9 Reagent Packs and Calibrators, Lot 1320, because they may produce positively biased results on specific VITROS systems.
Product
VITROS¿ Immunodiagnostic Products CA 19-9 Calibrators and Reagent Packs, Lot 1320 VITROS¿ CA 19-9 Reagent Packs are used on VITROS¿ ECi/ECiQ Immunodiagnostic Systems, VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600 Integrated Systems for the quantitative measurement of…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2216-2014·2014-08-20
Zimmer Recalls Double Offset Rasp Handles Due to Assembly Failure
Zimmer, Inc. is recalling 412 nonsterile Double Offset Rasp Handles because the handle may fail to remain assembled to the rasp during use.
Product
Double Offset Rasp Handle, Left Hand Nonsterile
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2224-2014·2014-08-20
Zimmer Recalls Nonsterile Orthopedic Rasp Handles Due to Assembly Failure
Zimmer, Inc. is recalling 412 units of VER2 DBL OFFSET RASP HANDLE, LT Nonsterile because the handle may fail to remain assembled to the rasp during use.
Product
VER2 DBL OFFSET RASP HANDLE, LT Nonsterile
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2200-2014·2014-08-20
Gambro Recalls Prisma HF1000 Presets Due to Connector Breakage
Gambro Renal Products is recalling Prisma HF1000 presets because connector breakages can cause leakage of liquid or blood.
Product
Prisma HF1000 preset (new design). Product number 107639. Each set is packaged in a plastic pouch, 4 pouches per carton box
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2182-2014·2014-08-20
Integra Recalls NewPort MIS System Due to Potential Component Mixing
Integra LifeSciences is recalling four units of the NewPort MIS System because demonstration components may have been mixed with surgical components.
Product
Integra NewPort MIS System Model No. NWPIMP (NewPort Implant Tray w/ Components) NWP2INSTP (NewPort Instrument Tray w/ Components) The NewPort System is intended to be used as a temporary or permanent posterior, non-cervical implant to correct spinal disorders…
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2220-2014·2014-08-20
Zimmer Recalls Double Offset Rasp Handles Due to Assembly Failure
Zimmer, Inc. is recalling 412 units of Double Offset Rasp Handles because the handles may fail to remain assembled to the rasp during use.
Product
Double Offset Rasp Handle, Right Hand Nonsterile
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2222-2014·2014-08-20
Zimmer Recalls Double Offset Rasp Handles Due to Assembly Failure
Zimmer, Inc. is recalling 412 units of Double Offset Rasp Handles because the handle may fail to remain assembled to the rasp during use.
Product
Double Offset Rasp Handle, Right Hand Nonsterile
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2213-2014·2014-08-20
Brainlab Navigation Spine & Trauma 3D Software Recalled for Registration Error
Brainlab AG is recalling 17 Navigation Spine & Trauma 3D software systems worldwide due to a defect in automatic CT image registration.
Product
Navigation Spine & Trauma 3D Version 2.0 and 2.1 Is intended as an intraoperative image-guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2234-2014·2014-08-20
Vital Sync Virtual Patient Monitoring Platform software recall for alarm mismatch
Nellcor Puritan Bennett Inc. is recalling Vital Sync software due to a mismatch between alarm priorities on medical devices and the monitoring system.
Product
Vital Sync" VPMP & IM, software, V2.4. (DVD), packaged on a CD or other electronically controlled device. CDs are packaged in clam shell jeweled cases within a carton box. The Vital Sync Virtual Patient Monitoring Platform is intended to be used by healthcare professionals…
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-2193-2014·2014-08-20
Gambro Recalls Prismaflex TPE 2000 Sets Due to Connector Breakage
Gambro Renal Products is recalling Prismaflex TPE 2000 sets because connector breakages can cause leakage of liquid or blood.
Product
Prismaflex TPE 2000 set, Product Number 1071441. Each set is packaged in a plastic pouch, 4 pouches per carton box
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2173-2014·2014-08-20
Medtronic MiniMed Implantable Insulin Pump Recalled for Malfunction
Medtronic MiniMed is recalling 764 Implantable Insulin Pumps due to reports of pump malfunction causing insulin delivery to stop before the device's 7-year useful life ends.
Product
Medtronic MiniMed Implantable Insulin Pump, Model No. MMT-2007D
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2194-2014·2014-08-20
Gambro Recalls Prisma TPE 2000 Sets Due to Connector Breakage
Gambro Renal Products is recalling Prisma TPE 2000 sets because connector breakages can cause liquid or blood leakage.
Product
Prisma TPE 2000 set. Product number 109672. Each set is packaged in a plastic pouch, 4 pouches per carton box
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2229-2014·2014-08-20
Zimmer Recalls Nonsterile VER2 Handle Due to Assembly Failure
Zimmer, Inc. is recalling 412 units of the VER2 Handle, Pin Rework, RT Nonsterile because the handle may fail to remain assembled to the rasp during use.
Product
VER2 HANDLE, PIN REWORK, RT Nonsterile
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2167-2014·2014-08-20
Esaote PA230E Ultrasound Transducer Recalled for Excessive Surface Temperature
Biosound Esaote, Inc. is recalling 1,301 PA230E ultrasound transducers because they may exceed maximum allowable surface temperature limits under specific settings.
Product
Esaote PA230E Transducer A portable and cart base ultrasound system for general and cardiovascular imaging
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2210-2014·2014-08-20
Medical Positioning Rapid Response HUT Table Recall for Malfunction Risk
Medical Positioning Inc. is recalling 17 Rapid Response HUT tables because a defective component may cause the table to drop into the Trendelenburg position more rapidly than normal under excessive weight.
Product
Medical Positioning Rapid Response HUT table with Dual 2 Way Drop Section, Powered Medical Examination table, Model # 1217. Product Usage: Used to conduct syncope examinations.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2174-2014·2014-08-20
Siemens Linear Accelerators Recalled for Potential Patient Collision Risk
Siemens Medical Solutions is recalling 160 linear accelerators because automatic treatment movements could cause the machine to collide with patients.
Product
Siemens Linear Accelerators of type ARTISTE, ONCOR, and PRIMUS with Automatic Sequenced Cancer Treatment Delivery Option.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2172-2014·2014-08-20
Medtronic Recalls Ascenda Intrathecal Catheters Due to Retainer Ring Defect
Medtronic is recalling specific lots of Ascenda Intrathecal Catheters and Revision Kits because a retainer ring component may not meet specifications, risking catheter disconnection.
Product
Medtronic Ascenda Intrathecal Catheter models 8780 and 8781, and Ascenda Intrathecal Catheter Pump Segment Revision Kit, model 8784. The Ascenda Intrathecal Catheter is part of an infusion system that stores and delivers parenteral drugs to the intrathecal space. The…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2218-2014·2014-08-20
Zimmer Recalls Double Offset Rasp Handles Due to Assembly Failure
Zimmer, Inc. is recalling 412 Double Offset Rasp Handles because the handle may fail to remain assembled to the rasp during use.
Product
Double Offset Rasp Handle, Left Hand Nonsterile
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2207-2014·2014-08-20
Gambro Recalls X-MARS Sets Due to Connector Breakage and Leakage
Gambro Renal Products is recalling X-MARS Sets because connector breakages can cause leakage of liquid or blood.
Product
X-MARS Set (component of MARS Treatment Kit Type 1116/1 X-MARS US), Product Number 800541
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2232-2014·2014-08-20
BioMerieux Recalls VIDAS D-Dimer Exclusion II Test Kits
BioMerieux SA is recalling 2,160 units of VIDAS D-Dimer Exclusion II tests due to complaints of non-repeatable results that may cause false negatives.
Product
VIDAS D-Dimer Exclusion II, an automated quantitative test for use on instruments of the VIDAS family for the immunoenzymatic determination of fibrin degradation products in human plasma using the Enzyme Linked Fluorescent Assay technique. Also indicated for use in conjunction…
Category
Medical Device
Distribution
40 states
HighFDA (Devices)·Z-2205-2014·2014-08-20
Gambro Recalls Prismaflex HF 1400 Dialysis Sets Due to Connector Breakage
Gambro Renal Products is recalling Prismaflex HF 1400 dialysis sets because connector breakages can cause leakage of liquid or blood.
Product
Prismaflex HF 1400. Product number 107142. Each set is packaged in a plastic pouch, 4 pouches per carton box
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2175-2014·2014-08-20
Agfa Healthcare Recalls DX-D 600 Imaging Packages Due to Crane Movement
Agfa Healthcare is recalling 17 DX-D 600 imaging packages because the overhead tube crane may move uncontrolled. Customers should stop using the equipment.
Product
DX-D 600 - DXD Imaging Package Product Usage:Is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and…
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-2223-2014·2014-08-20
Zimmer Recalls Nonsterile Orthopedic Rasps Due to Handle Failure
Zimmer, Inc. is recalling 412 units of nonsterile orthopedic rasps because the handle may fail to remain assembled during use.
Product
Vl DBL OFFST WI LRG STPL, RT Nonsterile
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2211-2014·2014-08-20
Medical Positioning Rapid Response HUT Table Recalled for Malfunction Risk
Medical Positioning Inc. is recalling Model # 1219 HUT tables because a defective component may cause the table to drop rapidly into the Trendelenburg position under excessive weight.
Product
Medical Positioning Rapid Response HUT table, Powered Medical Examination table, Model # 1219. Product Usage: Used to conduct syncope examinations.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2198-2014·2014-08-20
Gambro Recalls Prisma M100 Sets Due to Connector Breakage
Gambro Renal Products is recalling Prisma M100 sets because connector breakages can cause liquid or blood to leak.
Product
Prisma M100 set. Product number 104182. Each set is packaged in a plastic pouch, 4 pouches per carton box
Category
Medical Device
Distribution
0 states

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