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

30201–30225 of 40325

HighFDA (Devices)·Z-1610-2016·2016-05-11
Applied Medical Recalls Wilson Penile Implantation System Retractor Frame
Applied Medical Technology Inc is recalling Wilson Penile Implantation System Retractor Frames due to a reported open pouch that breaches sterilization validation.
Product
Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile Elevation Strap, SINGLE USE ONLY Rx ONLY (USA) STERILE EO Do Not Resterilize Product Usage: Indicated to aid in tissue retraction during a surgical procedure.
Category
Medical Device
Distribution
28 states
HighFDA (Devices)·Z-1598-2016·2016-05-11
Siemens MAGNETOM MRI Systems Recalled Due to Magnetic Table Cover Hazard
Siemens is recalling eight MAGNETOM Aera/Skyra MRI systems because the patient table's docking station cover may contain a magnetic plate that attracts to the main magnet.
Product
MAGNETOM Aera/Skyra Systems, whole body magnetic resonance imaging systems, Model numbers 10432914, 10432915. Docking station top cover (part no# 10591430) of the removable patient table.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1611-2016·2016-05-11
Applied Medical Recalls Wilson Implantation System Due to Sterilization Breach
Applied Medical Technology Inc is recalling 1,100 units of the Wilson Implantation System after a complaint revealed an open pouch that breached sterilization validation.
Product
Wilson Implantation System Product Usage: Indicated to aid in tissue retraction during a surgical procedure.
Category
Medical Device
Distribution
28 states
HighFDA (Devices)·Z-1609-2016·2016-05-11
Applied Medical Technology Recalls Self-Retaining Retractor Frames Due to Sterilization Breach
Applied Medical Technology is recalling 3,754 units of TLC Self-Retaining Retractor Frames because a complaint reported an open pouch, which breaches sterilization validation.
Product
TLC¿ Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) STERILE EO Do Not Resterilize. Product Usage: Indicated to aid in tissue retraction during a surgical procedure.
Category
Medical Device
Distribution
28 states
HighFDA (Devices)·Z-1608-2016·2016-05-11
Applied Medical Recalls TLC Self Retaining Retractor Systems Due to Sterilization Breach
Applied Medical Technology Inc is recalling 5,334 units of TLC Self Retaining Retractor Systems because a complaint reported an open pouch that breaches sterilization validation.
Product
TLC¿ Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY Product Usage: Indicated to aid in tissue retraction during a surgical procedure.
Category
Medical Device
Distribution
28 states
HighFDA (Devices)·Z-1600-2016·2016-05-11
Nuvectra Algovita Spinal Cord Stimulation Programmer Recall for Software Defect
Nuvectra is recalling 17 Algovita Spinal Cord Stimulation System Clinical Programmers (Model 4500) because a software defect may prevent users from recharging the implantable pulse generator.
Product
Nuvectra, Algovita Spinal Cord Stimulation System Clinical Programmer, Model 4500. For use with Algovita Spinal Cord Stimulation Systems. The version of the software in the Clinician Programmer is v1.1.5. The Algovita Spinal Cord Stimulation system consists of a stimulator…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1586-2016·2016-05-11
Ab Sciex Analyst MD Software Recall for Incorrect Diagnostic Results
Ab Sciex is recalling Analyst MD software versions 1.6.1 and 1.6.2 because it may display wrong quantitative results, potentially leading to incorrect patient diagnoses.
Product
Analyst¿ MD Version 1.6.1 and 1.6.2 Software used with the following instruments: API 3200MD" LC/MS/MS System, Instrument Part Number: 5024501; 3200MD QTRAP¿ LC/MS/MS System, Instrument Part Number: 5024500; Triple Quad" 4500MD LC/MS/MS System, Instrument Part Number: 5031257…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1601-2016·2016-05-11
Siemens Syngo Dynamics PACS Software Recall for Workflow Error
Siemens is recalling 84 units of Syngo Dynamics software due to a defect that may cause old measurements to be carried forward into new reports.
Product
Syngo Dynamics; Kinetdx Picture Archiving and Communications System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1589-2016·2016-05-11
GE Revolution CT Recalled for Potential X-Ray Tube Loosening
GE Medical Systems is recalling 26 Revolution CT systems worldwide because a manufacturing error may cause the X-ray tube to loosen, leading to scan errors or image artifacts.
Product
GE, Revolution CT. The system is intended for head, whole body, cardiac, and vascular X-ray Computed Tomography applications
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-1596-2016·2016-05-11
bioMerieux Recalls VITEK 2 Gram Positive Susceptibility Test Cards
bioMerieux is recalling VITEK 2 Gram Positive Susceptibility Test Cards because they may produce false susceptible results for specific bacteria to Minocycline.
Product
VITEK 2 Gram Positive Susceptibility Test Cards (AST-P605), REF 22 325. 20 Cards/Kit. bioMerieux, Inc, Durham, North Carolina 27712. VITEK 2 is an automated system consisting of instruments, software, and reagent cards designed for the identification and antimicrobial…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1590-2016·2016-05-11
Biosense Webster Recalls Pentaray Catheters for Labeling Clarification
Biosense Webster is recalling Pentaray NAV High-Density Mapping Catheters to clarify contraindication language regarding patients with prosthetic valves.
Product
Pentaray NAV High-Density Mapping Catheter, Catalog No. D128201, D128202, D128203, D128204, D128205, D128206 The Biosense Webster Pentaray NAV High-Density Mapping Catheter is intended for multiple electrode electrophysiological mapping of cardiac structures in the heart…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1597-2016·2016-05-11
Alcon Recalls INFINITI Ultrasound Packs Due to Tubing Leakage
Alcon Research is recalling INFINITI Ultrasound Packs because the irrigation line tubing may leak near the white luer.
Product
INFINITI Ultrasound Pack. Catalog Numbers: 8065751716, 8065751717, 8065751718, 8065751720, 8065751721, 8065751723. An ophthalmic microsurgical system indicated for phacoemulsification and removal of cataracts.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1593-2016·2016-05-11
Carestream Image Suite V3 Recalled for Incorrect Image Annotation
Carestream Health is recalling Image Suite V3 units due to a software error that displays incorrect left/right image annotations.
Product
CARESTREAM Image Suite V3: MINI-PACS/F IMG ST/CLASSIC: REF/Catalog # 1036490; MINI-PACS/F IMG ST/POC&VITA: REF/Catalog # 1036508; MINI-PACS/F IMG ST/CLASSIC/INDIA: REF/Catalog # 1036417; MINI-PACS/F IMG ST/ POC&VITA /INDIA: REF/Catalog # 1036425 -- Made in USA by: Carestream…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1594-2016·2016-05-11
Carestream Image Suite V4 Recalled for Incorrect Image Annotation Display
Carestream Health is recalling Image Suite V4 systems because a complaint reported that image annotations displayed 'L (Left)' instead of 'R (Right)'.
Product
CARESTREAM Image Suite V4; Image Suite V4: DICOM STORE SCP: REF/Catalog # 1056191, DICOM STORE SCP/FOR IMAGE SUITE V4: REF/Catalog # 6566988; Image Suite V4 Bundles: IMAGESUITE STANDALONE PACS: REF/Catalog # 1741289, IMAGESUITE STANDALONE PACS FOR INDIA: REF/Catalog # 1741297…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1603-2016·2016-05-11
Ferno-Washington Recalls Pediatric Traction Splint Straps Due to Labeling Error
Ferno-Washington is recalling 153 pediatric traction splint strap kits because they were shipped in adult-labeled packaging. This labeling error could lead to the use of the wrong size equipment for patients.
Product
Poly-bags containing splint strap labeled with "Pediatric" sticker. Each strap kit contains adjustable length leg straps, ankle wrap, a thigh pad and a heel stand. The strap kits are applied to the traction splint frame to immobilize and provide traction for a patients leg.
Category
Medical Device
Distribution
21 states
ModerateFDA (Devices)·Z-1599-2016·2016-05-11
Fujifilm Smart CR Digital Computed Radiography System Recalled for Power Supply Failure
Fujifilm Medical Systems is recalling 2,062 Smart CR Digital Computed Radiography Systems due to reports of power supply failure.
Product
Smart CR Digital Computed Radiography System; Model Number: CR-IR346RU
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1605-2016·2016-05-11
Medtronic CareLink Monitors Recalled for Firmware Dial-Up Configuration Error
Medtronic is recalling CareLink and CareLink Express monitors because a firmware update contained incorrect dial-up configuration data, potentially preventing data transmission to the CareLink Network.
Product
Medtronic CareLink" Monitor (2490C) and Medtronic CareLink Express" Monitor (2020B) Product Usage: The 2490C CareLink Home Monitors and 2020B CareLink Express Monitors are remote monitoring systems that interrogate implanted devices and transmit the data to Medtronic s…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1588-2016·2016-05-11
Mako Surgical Recalls MAKOplasty Hip Array Kit Laminate Due to Labeling Error
Mako Surgical Corporation is recalling 10 units of the MAKOplasty Hip Array Kit Laminate 150230 because the product may list two part numbers for the RIO Base Array.
Product
MAKOplasty Hip Array Kit Laminate 150230
Category
Medical Device
Distribution
5 states
ModerateFDA (Devices)·Z-1595-2016·2016-05-11
Radiometer TCM CombiM Modules Recalled for Alarm Volume Error
Radiometer America is recalling TCM CombiM Modules 903-111 because the alarm may sound louder than the pre-set maximum volume.
Product
TCM CombiM Modules 903-111
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1607-2016·2016-05-11
Toshiba Celesteion PET/CT Systems Recalled for Detector Performance Degradation
Toshiba American Medical Systems is recalling three Celesteion PET/CT systems due to potential degradation of detector performance.
Product
Toshiba American Medical Systems Celesteion, Item Code: PCA-9000A/2, 9000A/3B, 9000A/2B This system is designed to acquire CT images, PET images, and fusion images (superimposed PET and CT images). The images that can be acquired include planar images (for any position and from…
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-1587-2016·2016-05-11
Livongo Health Recalls In Touch Blood Glucose Monitoring System Inserts
Livongo Health is recalling 63,000 units of the In Touch Blood Glucose Monitoring System because the instructional insert omitted specific sensor accuracy limitations.
Product
The Livongo Health In Touch¿ Blood Glucose Monitoring System (BGMS), is an Over-The-Counter (OTC) system designed for the self- monitoring of blood glucose by persons with diabetes in home settings to aid in their diabetes management.
Category
Medical Device
Distribution
22 states
ModerateFDA (Devices)·Z-1592-2016·2016-05-11
Siemens ACUSON SC2000 Ultrasound System Recalled for Trackball Control Failure
Siemens is recalling 87 ACUSON SC2000 ultrasound systems because the trackball may fail to control specific imaging parameters during transesophageal procedures.
Product
ACUSON SC2000 Ultrasound imaging system with software version VB10C and using transesophageal (TEE) transducer Z6Ms, V5Ms or V7M. Model number: 10433816.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1604-2016·2016-05-11
Ferno-Washington Recalls Traction Splint Straps Due to Incorrect Packaging Labels
Ferno-Washington Inc. is recalling 270 traction splint strap kits because the outside packaging labels for adult and pediatric sizes were swapped.
Product
Poly-bags containing the strap labeled with "Adult" sticker. Each strap kit contains adjustable length leg straps, ankle wrap, a thigh pad and a heel stand. The strap kits are applied to the traction splint frame to immobilize and provide traction for a patients leg.
Category
Medical Device
Distribution
21 states
ModerateFDA (Devices)·Z-1602-2016·2016-05-11
Medtronic Midas Rex Dissecting Tools Recalled for Labeling Errors
Medtronic is recalling 81 Midas Rex Dissecting Tools due to incorrect color coding and attachment references on the labeling.
Product
Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for use in neurosurgery.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1591-2016·2016-05-11
Biosense Webster Recalls Pentaray Catheters for Labeling Clarification
Biosense Webster is recalling Pentaray Catheters to clarify contraindication language regarding patients with prosthetic valves in the product labeling.
Product
Pentaray NAV High-Density Mapping ECO Catheter, Catalog No. D128207, D128208, D128209, D128210, D128211, D128212 The Biosense Webster Pentaray NAV High-Density Mapping Catheter is intended for multiple electrode electrophysiological mapping of cardiac structures in the heart…
Category
Medical Device
Distribution
Distributed nationwide

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