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

31851–31875 of 40449

HighFDA (Devices)·Z-0031-2016·2015-10-14
Resource Optimization & Innovation Recalls Sterile C-Section Surgical Kits
Resource Optimization & Innovation LLC is recalling 600 sterile C-section surgical kits because equipment glove components may have splits or holes that compromise sterility.
Product
regard Item Number: 800408, Sterile, LD0477 - C-Section Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROI, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a…
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0063-2016·2015-10-14
Resource Optimization & Innovation Recalls Sterile C-Section Surgical Kits
Resource Optimization & Innovation LLC is recalling 416 sterile C-section surgical kits because a glove component may have splits or holes that compromise sterility.
Product
regard Item Number: 800557, Sterile, LD0646 - C-Section - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical…
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0056-2016·2015-10-14
Resource Optimization & Innovation LLC Recalls Sterile Extremity Surgical Kits
Resource Optimization & Innovation LLC is recalling 672 sterile extremity surgical kits because the equipment glove component may contain splits or holes that compromise sterility.
Product
regard Item Number: 800548, Sterile, OR0637 - Extremity - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical…
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0062-2016·2015-10-14
Resource Optimization & Innovation LLC Recalls Pediatric Cardiac Catheterization Surgical Kits
Resource Optimization & Innovation LLC is recalling 24 pediatric cardiac catheterization surgical kits because the equipment glove component may contain splits or holes that compromise sterility.
Product
regard Item Number: 800555, Sterile, HT0644 - Pediatric Card Cath - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a…
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0087-2016·2015-10-14
Resource Optimization & Innovation Recalls Sterile Surgical Kits Due to Sterility Concerns
Resource Optimization & Innovation LLC is recalling 68 sterile surgical kits because equipment glove components may have splits or holes that compromise sterility.
Product
regard Item Number: 800091001, Sterile, LD0692A - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a…
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0096-2016·2015-10-14
FDA Recalls 924 Sterile Lap Chole Surgical Kits Due to Sterility Compromise
Resource Optimization & Innovation LLC is recalling 924 sterile surgical kits because equipment glove components may contain splits or holes that compromise sterility.
Product
regard Item Number: 800528001, Sterile, GS0612A - Lap Chole Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a…
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0035-2016·2015-10-14
Resource Optimization & Innovation Recalls 288 Sterile Vascular Surgical Kits
Resource Optimization & Innovation LLC is recalling 288 sterile vascular surgical kits because a glove component may have splits or holes that compromise sterility.
Product
regard Item Number: 800413, Sterile, CV0482 - Vascular Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a…
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0066-2016·2015-10-14
FDA Recalls 448 Sterile Laparoscopic Cholecystectomy Surgical Kits
Resource Optimization & Innovation LLC is recalling 448 sterile surgical kits because a glove component may have splits or holes that compromise sterility.
Product
regard Item Number: 800560, Sterile, GS0649 - Lap Chole - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical…
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0088-2016·2015-10-14
Resource Optimization & Innovation Recalls Sterile Orthopedic Surgical Kits
Resource Optimization & Innovation LLC is recalling 1,476 sterile orthopedic surgical kits because the equipment glove component may have splits or holes that compromise sterility.
Product
regard Item Number: 800407001, Sterile, OR0476A - Ortho Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a…
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0034-2016·2015-10-14
FDA Recalls Sterile Neuro Surgical Kits Due to Sterility Compromise
Resource Optimization & Innovation LLC is recalling 904 sterile neuro surgical kits because equipment glove components may have splits or holes that compromise sterility.
Product
regard Item Number: 800411, Sterile, NU0480 - Neuro Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical…
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0083-2016·2015-10-14
Resource Optimization & Innovation Recalls Sterile Total Hip Surgical Kits
Resource Optimization & Innovation LLC is recalling 24 sterile total hip surgical kits because a glove component may have splits or holes that compromise sterility.
Product
regard Item Number: 880330, Sterile, OR0761 - Total Hip - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical…
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-0024-2016·2015-10-14
Synthes Periarticular Insertion Handles and Aiming Arms Recalled for Fit Issues
Synthes (USA) Products LLC is recalling 172 units of Periarticular Insertion Handles and Aiming Arms because they cannot be secured to subsequent device versions as intended.
Product
Synthes Periarticular Insertion Handle for 4.5mm LCP Proximal Tibia Plates and Periarticular Aiming Arm for 4.5mm LCP Proximal Tibia Plates
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0105-2016·2015-10-14
CooperSurgical LEEP REDIKIT Recalled for Incorrect Lidocaine Concentration Labeling
CooperSurgical is recalling LEEP REDIKIT surgical kits because the labels list 2% Lidocaine HCl, but the kits contain 1% Lidocaine HCl vials.
Product
CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Electrosurgical Excision Procedure P/N 6061
Category
Medical Device
Distribution
20 states
ModerateFDA (Devices)·Z-0022-2016·2015-10-14
Medtronic SureScan Pacemaker ID Cards Mislabel MR Conditional Status
Medtronic is recalling 777 identification cards for SureScan pacemaker patients that incorrectly indicate the entire system is MR Conditional.
Product
Medtronic Medical Device Identification Card for SureScan pacemaker patients. The front of this card identifies the implanted pacing system components currently registered to the patient. The back of the card lists patient's following physician as well as specific…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0020-2016·2015-10-14
Siemens SOMATOM Definition Flash CT Scanner Software Recall
Siemens Medical Solutions USA is recalling 113 SOMATOM Definition Flash CT scanners due to a software bug in version VA48A_SP0 that affects visual warnings and image quality.
Product
SOMATOM Definition Flash; intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0025-2016·2015-10-14
Integra Recalls Universal Compact Head Ring Adapter Plate Due to Assembly Error
Integra LifeSciences Corp. is recalling six Universal Compact Head Ring Adapter Plates that do not assemble properly due to a manufacturing drawing error.
Product
Universal Compact Head Ring Adapter Plate (UCHRAP), a component of the Universal Compact Head Ring Adapter, UCHRA. The UCHRA is a component of the Integra¿ CRW¿ Precision Arc Stereotactic System.
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-0106-2016·2015-10-14
Siemens Syngo RT Oncologist software update addresses safety issues
Siemens Medical Solutions is updating Syngo RT Oncologist software versions 4.2 and 4.3 to fix safety and performance issues.
Product
Syngo RT Oncologist, an optional accessory to the linear accelerator system and permits localization, contouring, segmentation, image review, and review and approval of treatment plan parameters. In addition, it includes tools and administrative functions to aid in the…
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-0021-2016·2015-10-14
Siemens SOMATOM Definition AS CT Scanner Software Recall
Siemens Medical Solutions is recalling 113 SOMATOM Definition AS CT scanners to fix a software bug affecting visual warnings and image quality.
Product
SOMATOM Definition AS, intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0027-2016·2015-10-14
Zimmer Universal Locking System Recalled for Incorrect Silk Screening
Zimmer, Inc. is recalling 18 units of the Universal Locking System due to incorrect catalog numbers printed on the trays.
Product
Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain…
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-0023-2016·2015-10-14
GE Healthcare Recalls Centricity PACS IW Due to Missing Images
GE Healthcare is recalling 921 Centricity PACS IW systems worldwide because images may be missing when a specific system parameter is set to a value greater than 1.
Product
Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0109-2016·2015-10-14
Beckman Coulter Recalls MICroSTREP plus Panels Due to Manufacturing Error
Beckman Coulter is recalling MICroSTREP plus 1 and 2 panels because a manufacturing error may cause antimicrobial degradation, leading to false resistant results.
Product
MICroSTREP plus 2 Panel, Part No. B1027-202 Product Usage: MicroScan MICroSTREP plus panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0110-2016·2015-10-14
Beckman Coulter Recalls Access Free T3 Reagent Kits Due to Filling Errors
Beckman Coulter is recalling Access Free T3 Reagent Kits because they were filled incorrectly and contain insufficient reagents.
Product
Access Free T3 Reagent Kit, P/N A13422 The Access Free T3 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free triiodothyronine levels in human serum and plasma using the Access Immunoassay Systems.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0005-2016·2015-10-14
Toshiba Recalls Celesteion PET/CT Systems Due to Data Loss Risk
Toshiba American Medical Systems is recalling one Celesteion PCA-9000A/2 PET/CT System in Nevada because a software defect may prevent raw data from being saved during specific scans.
Product
Celesteion PCA-9000A/2 PET/CT System
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0019-2016·2015-10-14
Siemens SOMATOM Definition Edge CT Scanner Software Recall
Siemens Medical Solutions is recalling 113 SOMATOM Definition Edge CT scanners due to a software bug affecting visual warnings and image quality.
Product
SOMATOM Definition Edge; intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2825-2015·2015-10-07
Arrow Kits with Medtronic Syringes Recalled for Compromised Sterility
Arrow International Inc. is recalling Arrow Kits containing Medtronic Covidien 0.9% Sodium Chloride Flush Syringes due to compromised sterility of the outer barrel.
Product
Arrow Kits with Medtronic Covidien 0.9% Sodium Chloride Flush Syringes
Category
Medical Device
Distribution
Distributed nationwide

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31851–31875 of 40449