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

12876–12900 of 39988

HighFDA (Devices)·Z-0711-2022·2022-03-09
Bronchial Microbiology Brush Labeling Error—Cleared Only for Gastrointestinal Use
Hobbs Medical is recalling 38,357 Bronchial Microbiology Brushes due to labeling that incorrectly indicates bronchial use. The device is cleared only for gastrointestinal use.
Product
Bronchial Microbiology Brush, Catalog Number 4310 and 4320. Microbial sampling is performed by compressing a spring as the base of brush wire to expose the brush, scraping the desired surface, and releasing the compression on the spring which retracts the brush back into the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0706-2022·2022-03-09
K2M Everest MI XT Outer Dilators recalled for manufacturing defect
K2M is recalling 686 Everest MI XT Outer Dilator units due to a manufacturing nonconformance that prevents them from fitting properly with inner dilators during surgical procedures.
Product
Everest MI XT Outer Dilator, Catalog Number 5101-90168
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0705-2022·2022-03-09
K2M Everest MI XT Inner Dilator Recalled for Manufacturing Fit Defect
K2M recalled 686 units of the Everest MI XT Inner Dilator due to a manufacturing nonconformance preventing proper fit with outer dilators during surgery. Two complaints prompted the recall.
Product
Everest MI XT Inner Dilator, Catalog Number 5101-90167
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0684-2022·2022-03-09
BioPro Titanium MPJ Toe Implant MRI Safety Labeling Error
BioPro is recalling Titanium MPJ toe implants due to false MRI safety labeling. The instructions and patient cards incorrectly state the device was tested for MRI safety, but no testing was conducted.
Product
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC ML, Part ID 16815
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0708-2022·2022-03-09
OPAQUE Lacrimal Plugs recalled due to sterile pouch seal defect
Lacrimedics is recalling approximately 5,767 units of OPAQUE Lacrimal Plugs due to potential defects in the sterile pouch seal that could compromise product sterility. The affected devices were distributed nationwide and internationally.
Product
OPAQUE Herrick Lacrimal Plugs, HP3, 0.3 mm, HP5, 0.5mm, HP7, 0.7.mm, STERILE, EO, Rx only, CE Dry eye treatment
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0654-2022·2022-03-09
Digital Angiography System Generators May Emit Excessive X-Ray Radiation
Shimadzu Medical Systems is recalling Digital Angiography System generators due to potential excessive x-ray radiation in fluoroscopic mode. Installation issues may cause radiation dose rates to exceed safe limits.
Product
Digital Angiography System Bransist safire Generator Model D150GC-40
Category
Medical Device
Distribution
15 states
HighFDA (Devices)·Z-0698-2022·2022-03-09
QC Control Panels Fail Shelf Life Stability Test at 24 Months
Microbiologics QC control panels for bacterial diagnostic testing failed shelf life validation at 24 months. The 29 affected units were distributed across US states and internationally to Canada, UK, Australia, Belgium, and India.
Product
Microbiologics QC Sets and Panels. BD MAX" CT/GC/TV Verification and Control Panel. Containing High, Medium and Low Level Controls.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0707-2022·2022-03-09
Brasseler K-WIRE surgical instruments recalled for unsealed packaging
Brasseler USA is recalling 231 units of K-WIRE Double Trocar Smooth surgical instruments due to unsealed packaging that may compromise sterility.
Product
Brasseler USA, K-WIRE, Double Trocar Smooth, REF KM172-26-35S
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0685-2022·2022-03-09
BioPro Titanium Toe Implant Recalled for Incorrect MRI Safety Claims
BioPro Titanium MPJ toe implants contain incorrect documentation falsely claiming they are MR Conditional without proper testing. Patients should not assume these implants are safe for MRI.
Product
Titanium MPJ (Toe Implant)TOE JOINT TITANIUM NPC LG, Part ID 16816
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0682-2022·2022-03-09
Titanium Toe Implant Recalled for Incorrect MR Compatibility Claims
BioPro Titanium MPJ toe implants are being recalled due to incorrect statements in device labeling claiming MR Conditional status when MR testing was not performed on the titanium version.
Product
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC SM, Part ID 16813
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0701-2022·2022-03-09
Helix Elite Molecular Standards recalled due to shelf life test failure
Microbiologics Inc is recalling Helix Elite Molecular Standards for Inactivated Influenza A/B and Respiratory Syncytial Virus because shelf life testing failed at 24 months, potentially affecting product stability.
Product
Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Influenza A/B and Respiratory Syncytial Virus
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0709-2022·2022-03-09
Lacrimedics Collagen Plugs recalled for potential sterility seal compromise
Lacrimedics is recalling Collagen Plugs (models CP3, CP4, CP5) due to potential seal integrity defects in sterile pouches. The seals may contain channels that could compromise sterility and allow contamination.
Product
Collagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO, Rx Only, CE Dry eye treatment
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0714-2022·2022-03-09
Quality Control Kit Bacterial Strain Shows Unexpected Gentamicin Susceptibility
Microbiologics has recalled KWIK-STIK quality control kits due to a specific lot failing to meet resistance specifications for Gentamicin Synergy. The affected bacterial strain showed unexpected susceptibility when it should have been resistant.
Product
KWIK-STIK, Quality control kit for culture media, sold as: KWIK-STIK (single-pack) Enterococcus faecalis derived from ATCC 51299
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0692-2022·2022-03-09
AU/DxC AU Magnesium Test Kits Recalled Due to Measurement Error in Lipemic Samples
Beckman Coulter is recalling 181,776 AU/DxC AU Magnesium test kits because the test may give falsely elevated results in lipemic samples, potentially affecting clinical interpretation.
Product
AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850
Category
Medical Device
Distribution
50 states
ModerateFDA (Devices)·Z-0704-2022·2022-03-09
Diagnostic Quality Control Material Yields False-Positive Results in GBS Testing
A quality control negative control material in GBS diagnostic testing sets is yielding false-positive results, causing laboratory test failures and operational disruptions.
Product
QC Sets and Panels: KWIK-STIK Cepheid Smart GBS QC Set (Live Culture). Sets include: 1. 0864E4 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 2. 0864E5 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 3. 0864E7 Streptococcus agalactiae…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0679-2022·2022-03-09
DARCO Locking Bone Plate System Recalled for Incorrect Manufacturing and Distribution Dates
Wright Medical Technology is recalling the DARCO Locking Bone Plate System because product labels contain incorrect manufacturing and distribution dates. The recall affects 12 units distributed to Japan and the United Kingdom.
Product
The DARCO¿ Locking Bone Plate System is designed with rhombus (parallelogram) plates of biocompatible titanium. The plates use either 2.7mm or 3.5mm screws which intersect each other in pairs. The drill holes of the plates are aligned to assure the screws do not touch. The…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0697-2022·2022-03-09
Microbiologics QC Panel Recalled Due to Shelf Life Testing Failure
Microbiologics Inc is recalling its Helix Elite Extended Enteric Bacterial Verification Panel because real-time shelf life testing failed at 24 months.
Product
Microbiologics QC Sets and Panels: Helix Elite. Extended Enteric Bacterial Verification Panel (Inactivated Pellet) includes 21 pellets each comprised of the following 8 organisms: 1. S. Typhimurium derived from NCTC 74, 2. S. sonnei derived from NCTC 12984, 3. E. coli…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0703-2022·2022-03-09
QC Control Sets for GBS Testing Recalled Due to Contamination
Microbiologics QC sets used for GBS testing contain a negative control contaminated with Group B Streptococcus, causing test failures. Affects 541 units distributed nationwide.
Product
QC Sets and Panels: KWIK-STIK. Cepheid Xpert GBS QC Set (Live Culture). Sets include: 1. 0864E3 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 2. 0864E5 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 3. 0864E7 Streptococcus agalactiae…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0713-2022·2022-03-09
LYFO-DISK Quality Control Kit Lot Fails Antibiotic Resistance Specification
A lot of LYFO-DISK quality control kit was found susceptible to Gentamicin Synergy when it should have been resistant. The 153 affected units were distributed worldwide.
Product
LYFO-DISK, Quality control kit for culture media, sold as: LYFO-DISK Enterococcus faecalis derived from ATCC 51299
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0683-2022·2022-03-09
BioPro Titanium MPJ Toe Implant Recalled for Incorrect MR Compatibility Labeling
BioPro is recalling Titanium MPJ toe implants because instructions and patient cards falsely claim the devices are compatible with MRI imaging, when safety testing for this titanium version has not been conducted.
Product
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MD, Part ID 16814
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0672-2022·2022-03-02
Biomet Shoulder Implant Stem Recalled for Inadequate Coating Adhesion
Biomet is recalling a Comprehensive Shoulder System implant component due to a defect in the porous plasma coating. The coating may not have sufficient adhesion strength, compromising the implant's structural integrity.
Product
Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 14 MM, 55 MM Long Item Number: 113614
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0665-2022·2022-03-02
BD Vacutainer Luer Lok Access Device may shed particles causing false test results
BD's Vacutainer Luer Lok Access Device may release contaminant particles that can be misidentified as red blood cells in laboratory analysis, potentially leading to false elevated RBC counts.
Product
BD Vacutainer Luer Lok Access Device - intended as a sterile, single use device designed to provide a connection to a catheter port equipped with a threaded female luer during blood or urine sample collection using evacuated BD Vacutainer Blood or Urine Collection Tubes Catalog…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0670-2022·2022-03-02
Hip implant revision system recalled due to inadequate coating adhesion
Biomet is recalling 19 units of the Arcos Modular Revision Hip System because an incorrect rework process may have weakened the coating's adhesion strength, posing a potential implant failure risk.
Product
Arcos Modular Revision Hip System, Standard Cone Prox Body, Porous Plasma,Size A, 60 MM Item Number: 11-301301
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0658-2022·2022-03-02
NobelReplace dental implant components recalled for driver engagement defect
Nobel Biocare is recalling 702 NobelReplace dental implant components due to a manufacturing defect that prevents proper driver engagement. The defect could result in aborted or delayed surgical procedures.
Product
NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0669-2022·2022-03-02
RESODURA Matrix Onlay Recalled Due to Unsealed Packaging
Collagen Matrix is recalling RESODURA matrix onlay dural substitutes due to outer packaging that is not properly sealed, potentially compromising sterility and creating a risk of infection.
Product
RESODURA matrix onlay 10.0 cm x 12.5 cm - indicated as dural substitutes for the repair of dura matter. REF: DUMO10125
Category
Medical Device
Distribution
Distributed nationwide

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12876–12900 of 39988