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 deaths or serious injuries are reported, 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

12176–12200 of 13802

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-0710-2022·2022-03-09
Abbott Alinity m reaction units risk detachment during transport
Abbott Molecular is recalling 3063 kits of Alinity m Integrated Reaction Units due to potential detachment of reaction vessels from the unit cap during transport. No injuries have been reported.
Product
Alinity m Integrated Reaction Units (IRU)
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-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
0 states
HighFDA (Devices)·Z-0720-2022·2022-03-09
BUTLER Clear Dip Recalled for Lack of FDA Premarket Clearance
Sunstar Americas is recalling BUTLER Clear Dip nationwide due to lack of FDA premarket clearance. The product was distributed in 22,514 units across multiple lot codes.
Product
BUTLER Clear Dip, 12 bottles/case
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0690-2022·2022-03-09
Titanium Toe Implant Recalled for Incorrect MRI Safety Statements
BioPro is recalling Titanium MPJ toe implants due to false claims of MRI compatibility. The device instruction manual states it is MRI-safe despite not being tested.
Product
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MS, Part ID 17197
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-0696-2022·2022-03-09
MEDLINE Micro-Kill Bleach Germicidal Wipes Recall: Out-of-Specification Sodium Hypochlorite
MEDLINE recalls Micro-Kill Bleach Germicidal Wipes due to out-of-specification low levels of sodium hypochlorite, the active disinfecting ingredient. Affected batches may have reduced effectiveness.
Product
MEDLINE Micro-Kill Bleach Germicidal Bleach Wipes
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-0693-2022·2022-03-09
Regard TOTAL HIP surgical implant recalled due to incorrect product identification labeling
ROi CPS LLC is recalling 50 kits of Regard TOTAL HIP implants distributed in Missouri due to incorrect product identification labeling on individual kits. This mislabeling could result in the wrong implant being used in surgery.
Product
Regard, TOTAL HIP - SPRINGFIELD, Item No. 8800297010, Case Quantity: 2, Sterile
Category
Medical Device
Distribution
0 states
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-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-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 shea
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0686-2022·2022-03-09
Titanium Toe Implants Recalled for Incorrect MRI Safety Labeling
BioPro Titanium MPJ toe implants are recalled because labeling incorrectly claims MRI safety without actual testing. Patients should consult their physician before undergoing MRI procedures.
Product
Titanium MPJ (Toe Implant)TOE JOINT TITANIUM PC SM, Part ID 17035
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0715-2022·2022-03-09
Stryker medical implant recalled for manufacturing defect in barrier layer
Stryker is recalling MEDPOR Titan OFW implants after one unit was found with an incorrectly placed barrier layer. The defect resulted from manufacturing error rather than design.
Product
MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0655-2022·2022-03-09
Digital Angiography System generator may exceed safe radiation dose rates
Shimadzu recalled 28 Digital Angiography Systems with Generator Model D150GC-40 due to inadequate installation adjustment criteria that may cause x-ray radiation dose rates to exceed safe fluoroscopic imaging limits.
Product
Digital Angiography System Shimadzu Trinias Generator Model: D150GC-40
Category
Medical Device
Distribution
15 states
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 (Gro
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 var
Category
Medical Device
Distribution
0 states
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-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 derive
Category
Medical Device
Distribution
Distributed nationwide
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 (Grou
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-0668-2022·2022-03-02
Collagen Dura Substitute Membrane Recalled for Compromised Sterility
Collagen Matrix is recalling 68 units of DuraMatrix-Onlay Collagen Dura Substitute Membrane due to unsealed outer packaging that may compromise product sterility and increase infection risk.
Product
DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0cm x 12.5cm) REF: CDSLM45
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0667-2022·2022-03-02
Bard Surestep Intermittent Catheter Tray Recalled for Connection Leaks
C.R. Bard Inc recalled 1,620 units of Bard Surestep Intermittent Catheter Tray because the catheter may leak where it connects to the drain bag. No injuries have been reported.
Product
BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS16C
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0673-2022·2022-03-02
Biomet Shoulder Stem Implants Recalled for Coating Adhesion Defect
Biomet is recalling certain shoulder stem implants due to potential insufficient adhesion strength in the porous plasma coating. An improper rework process may have compromised the coating's integrity.
Product
Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 18 MM, 55 MM Long Item Number: 113618
Category
Medical Device
Distribution
Distributed nationwide

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