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

37901–37925 of 40449

HighFDA (Devices)·Z-1836-2013·2013-08-07
St. Jude Medical Recalls Eon Mini Implantable Pulse Generators
St. Jude Medical is recalling 34,617 Eon Mini implantable pulse generators worldwide due to a battery weld issue that can cause loss of pain relief.
Product
Eon Mini - 3788 (IPG), 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 and leg pain.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1813-2013·2013-08-07
Heartware HVAD Pump Implant Kit Recalled for Electrostatic Discharge Risk
HeartWare Inc is recalling HVAD Pump Implant Kits due to a potential electrostatic discharge (ESD) hazard. The recall covers 76 units in the US and 82 internationally.
Product
Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
Category
Medical Device
Distribution
29 states
HighFDA (Devices)·Z-1869-2013·2013-08-07
SpineFrontier Recalls PedFuse Screw Caddies Due to Misaligned Screw Compartments
SpineFrontier, Inc. is recalling 11 PedFuse Screw Caddies because the compartments for 8mm and 9mm screws were switched, creating a risk of using the wrong screw size during spinal surgery.
Product
Caddy - PedFuse, Screw Caddy, 8MM and 9MM, Part Number: 11-80009 Rev. B The caddy holds, in an organized fashion within the case, 8mm and 9mm pedicle screws used during implantation of pedicle screw system devices intended to provide immobilization and stabilization of…
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-1867-2013·2013-08-07
Mesa EZtest Biological Indicator Monitor Recall for Readout Time Issues
Mesa Laboratories is recalling EZtest biological indicator monitoring systems because the readout time does not match label claims.
Product
Mesa EZtest BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the efficacy of steam sterilization processes.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1826-2013·2013-08-07
SteriTec Biological Indicator Test Packs Recalled for Labeling Discrepancy
SteriTec is recalling specific lots of biological indicator test packs because the readout time does not match label claims.
Product
Getinge Assure Accufast BI Test Pack w/ 25 Controls, SteriTec Product Code PL 395/25, Distributor Product Code 61301606639 The Smart-Read Biological Test Pack with Instant Readout Integrator: is designed specifically for biological testing of 3 or 4 minutes or longer at 132…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1864-2013·2013-08-07
Acclarent Inspira AIR Balloon Dilation System Labeling Correction Recall
Acclarent is recalling Inspira AIR Balloon Dilation Systems to correct labeling and add warnings. The recall covers 1,217 units distributed in the US, Belgium, Canada, and Saudi Arabia.
Product
Inspira AIR Balloon Dilation system. Size 12 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1833-2013·2013-08-07
GE Healthcare Recalls Voluson Ultrasound Systems Due to Software Freeze
GE Healthcare is recalling 375 Voluson E6 and E8 ultrasound systems because an intermittent software error can cause the system to freeze.
Product
GE Healthcare, VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM. The device is a general purpose ultrasound system. Specific clinical applications remain the same as previously cleared: Fetal/OB; Abdominal (including GYN, pelvic and infertility monitoring/follicle…
Category
Medical Device
Distribution
30 states
ModerateFDA (Devices)·Z-1860-2013·2013-08-07
Acclarent Inspira AIR Balloon Dilation System Labeling Correction Recall
Acclarent, Inc. is recalling Inspira AIR Balloon Dilation Systems to correct labeling and clarify instructional steps.
Product
Inspira AIR Balloon Dilation system. Size 5 x 24 mm, Syringe volume 6-8 cc. Dilation of airway tree.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1814-2013·2013-08-07
Picis ED Pulsecheck Software Recall for Missing Prescription Notes
Picis Inc. is recalling ED Pulsecheck software versions 5.2 and 5.3 because prescription notes are not printed to the prescription or patient chart.
Product
Picis ED Pulsecheck - EMR Software Application - 2125, Software Versions: 5.2 and 5.3. The application stores patient information in a database, and it may analyze and/or display the data in different formats for evaluation by healthcare professionals for informational…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1849-2013·2013-08-07
GE Healthcare Recalls LOGIQ e Ultrasound Systems for Patient Data Linking Error
GE Healthcare is recalling 588 LOGIQ e ultrasound systems because image data from one patient may be linked to another patient's ID.
Product
GE Healthcare, LOGIQ e Ultrasound System. The LOGIQ i/e and Vivid e is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1870-2013·2013-08-07
SpineFrontier Recalls Three S-LIFT Slap Hammers Due to Malfunction
SpineFrontier, Inc. is recalling three S-LIFT Slap Hammers (Lot 56H26) distributed in Kansas and Texas because they malfunctioned.
Product
S-LIFT Slap Hammer, Part Number: 11-50204, Revision A The slap hammers are used primarily to remove trial instruments that are used to estimate sizes of intervertebral body fusion devices intended to promote fusion. These devices were used in conjunction with lumbar…
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-1861-2013·2013-08-07
Acclarent Inspira AIR Balloon Dilation System Labeling Correction Recall
Acclarent, Inc. is recalling Inspira AIR Balloon Dilation Systems to correct labeling and add warnings. The recall covers 2,366 units distributed in the US, Belgium, Canada, and Saudi Arabia.
Product
Inspira AIR Balloon Dilation system. Size 7 x 24 mm, Syringe volume 6-8 cc. Dilation of airway tree.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1830-2013·2013-08-07
Tosoh AIA Analyzer Pipette Tips Recalled Due to Size Inconsistency
Tosoh Smd Inc is recalling AIA Analyzer Pipette Tips because visual inspection found some tips were not uniform in size or length, causing error messages on analyzers.
Product
AIA Analyzer Pipette Tips used on Tosoh AIA-2000, AIA-1800, AIA-900 and AIA-600II Analyzers, 1000 tips/bag AIA-Analyzer Tips are disposable pipette tips packaged in bulk quantities and used on Tosoh Bioscience AIA Analyzers for lab analysis of various immunoassays.
Category
Medical Device
Distribution
44 states
ModerateFDA (Devices)·Z-1816-2013·2013-08-07
Synthes Large External Fixation Tube to Tube Clamp Recalled for Incorrect Insert
Synthes USA HQ, Inc. is recalling 8 units of Large External Fixation Tube to Tube Clamps because the provided insert incorrectly states the device is MR Safe instead of MR Conditional.
Product
Synthes Large External Fixation, MR Conditional, Tube to Tube Clamp, Part Number 390.007, Lot Number 6800599 Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-1812-2013·2013-08-07
BD Affirm VPIII Microbial Identification Tests Recalled for Invalid Control Results
Becton Dickinson is recalling 177 kits of BD Affirm VPIII Microbial Identification Tests because they may exhibit invalid internal negative control results.
Product
BD Affirm VPIII Microbial Identification Tests, packaged in kits, 120 test\kit, Catalog # 446257 and 24 test\kit, Catalog # 446252; kits are labeled in part ***Becton, Dickinson and Company, 7 Loveton Circle Sparks, MD 21152 USA, 800-638-8663, www.bd.com/ds*** The Affirm…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1862-2013·2013-08-07
Acclarent Recalls Inspira AIR Balloon Dilation System for Labeling Corrections
Acclarent, Inc. is recalling Inspira AIR Balloon Dilation Systems to correct labeling, add warnings, and clarify instructional steps.
Product
Inspira AIR Balloon Dilation system. Size 8.5 x 24 mm, Syringe volume 12 cc. Dilation of airway tree.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1834-2013·2013-08-07
Beckman Coulter AU5800 Clinical Chemistry Analyzer Software Recall
Beckman Coulter is recalling AU5800 Clinical Chemistry Analyzers due to a software error causing concentrated wash solution pump failures and leaks.
Product
AU5800 Clinical Chemistry Analyzer with Automation Ready Connection (All Software Versions), Model Numbers AU5811, AU5821, AU5831 and AU5841. This system is for in vitro diagnostic use only.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1846-2013·2013-08-07
Stryker Recalls Left GAMMA3 Nails Marked as Right
Stryker Howmedica Osteonics is recalling five units of the GAMMA3 System Long Nail Kit, Left, because they are incorrectly marked as right nails.
Product
GAMMA3 System Long Nail Kit, R2.0, Ti, Left Distributed in USA by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 USA A single use device intended for the temporary fixation, correction of stabilization of the right femur. The kit consists of…
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-1859-2013·2013-08-07
Siemens syngo Dynamics Information System Recall for Data Loss Risk
Siemens is recalling syngo Dynamics Information System versions 9.5 and VA10A because images may not be saved when specific modality settings are used.
Product
syngo Dynamics Information System (sDIS) versions 9.5 and VA10A. The syngo¿ Dynamics system is intended for the acceptance, transfer, display, storage, archive, and manipulation of digital medical images, including quantification and reportgeneration. syngo¿ Dynamics is…
Category
Medical Device
Distribution
7 states
ModerateFDA (Devices)·Z-1819-2013·2013-08-07
Custom Spine ISSYS LP Inverted Screw System Recall for Dimensional Defect
Custom Spine, Inc. is recalling 18 ISSYS LP Inverted Screws that were 5 mm shorter than the labeled specification.
Product
Custom Spine ISSYS LP Inverted Screw System. 8.5MM X 45 MM ISSYS LP Screw Rx Non-Sterile. Custom Spine, Inc. 9 Campus Dr. Parsippany, NJ 07054 USA. TEL: 973-808-0019 The ISSYS LP Spinal Fixation System is intended to help provide immobilization and stabilization of spinal…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1829-2013·2013-08-07
SteriTec Steam Biological Test Packs Recalled for Labeling Inaccuracy
SteriTec is recalling 360 units of Steam Biological Test Packs because the readout time does not match the label claims.
Product
Cardinal BI Stat Biological Test Pack with Instant Readout Integrator, SteriTec Product Code PL 160/A, Distributor Product Code T40311PE SteriTec Steam Biological Test Packs with Instant Readout Integrator Card: The Steam Biological Test Pack with Instant Readout Integrator…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1822-2013·2013-08-07
SteriTec Steam Biological Indicators Recalled for Labeling Inaccuracy
SteriTec is recalling EZTest Steam Biological Indicators because the readout time does not match the label claims.
Product
Medline Steam Biological Indicators, SteriTec Product Code PL 353, Distributor Product Code MDS200525 EZTest Steam Biological Indicator: Mesa EZTest Steam Biological Indicator is a self contained Biological Indicator intended for monitoring the efficacy of 121¿C, 132¿C, 134¿C…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1827-2013·2013-08-07
SteriTec Recalls Smart-Read Biological Indicators Due to Readout Time Issues
SteriTec is recalling Smart-Read Biological Indicators because the readout time does not match label claims. The recall affects 5,000 units distributed worldwide.
Product
Mesa Labs Smart-Read 10^5 EZ Test BI Test Pack, SteriTec Product Code PL 298/25, Distributor Product Code SRSP/25 The Smart-Read Biological Test Pack with Instant Readout Integrator: is designed specifically for biological testing of 3 or 4 minutes or longer at 1132 (27270…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1828-2013·2013-08-07
SteriTec Steam Biological Test Packs Recalled for Labeling Inaccuracy
SteriTec is recalling specific steam biological test packs because the readout time does not match the label claims.
Product
Medline Med-Checks BI Test packs with Instant Readout Integrator, SteriTec Product Code PL 200, Distributor Product Code MDS200500IR SteriTec Steam Biological Test Packs with Instant Readout Integrator Card: The Steam Biological Test Pack with Instant Readout Integrator is a…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1831-2013·2013-08-07
Wako uTAS DCP Reagent Cartridges Recalled for Accuracy Failures
Wako Life Sciences is recalling uTAS DCP reagent cartridges because they fail to meet accuracy standards at the low end of the measuring range.
Product
uTASWako DCP, Lot TG340 2013.11, REF 995-60701, Wako Pure Chemical Industries, Ltd. 1-2 Doshomachi 3-chome, Chuo-Ku Osaka 540-8605 Japan Distributed by Wako Diagnostics Wako Life Sciences, Inc. 1025 Terra Bella Ave., Suto A. Mountain View, CA 94043 USA. The product is a single…
Category
Medical Device
Distribution
6 states

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37901–37925 of 40449