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

12226–12250 of 13837

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
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-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-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
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-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-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-0675-2022·2022-03-02
Biomet Shoulder Implant Stem Coating Adhesion Defect Recall
Biomet is recalling shoulder implant stems due to improper rework of porous plasma coating, which may lack sufficient adhesion strength. Affected units may fail if the coating detaches.
Product
Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 12 MM, 83 MM Long Item Number: 113632
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0676-2022·2022-03-02
Biomet Shoulder Implant Stem Recalled for Coating Adhesion Defect
Biomet recalls 9 Comprehensive Shoulder System Mini Humeral Stems due to potential coating adhesion defects. An incorrect rework process may have compromised the porous plasma coating adhesion strength.
Product
Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 13 MM, 83 MM Long Item Number: 113633
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0671-2022·2022-03-02
Shoulder Implant Stem Coating Defect Due to Invalid Rework Process
Biomet is recalling a shoulder implant stem due to a manufacturing defect in the porous plasma coating. Internal testing indicated the coating may not have sufficient adhesion strength after an unvalidated waterjet rework process.
Product
Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 11 MM, 55 MM Long Item Number: 113611
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
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-0661-2022·2022-03-02
Video Camera Ceiling Tile Kits May Fall in Some Installations
Natus Neurology is recalling IPELA FHD PTZ tile kits that may not fit properly in thinner ceiling tile grids and could suddenly fall, creating a safety hazard.
Product
IPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus Neuroworks/Sleepworks software
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0677-2022·2022-03-02
Shoulder Implant Stem Recalled for Defective Coating Adhesion
Biomet is recalling Comprehensive Shoulder System Mini Humeral Stems due to defective porous plasma coating adhesion. Internal testing indicated affected parts may lack sufficient coating strength.
Product
Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 15 MM, 83 MM Long Item Number: 113635
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
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-0674-2022·2022-03-02
Comprehensive Shoulder System Mini Humeral Stem Recalled for Coating Adhesion Defect
Biomet recalls 11 units of its Comprehensive Shoulder System Mini Humeral Stem due to potential coating adhesion defects. An unvalidated rework process was applied to vendor-coated parts, risking implant failure.
Product
Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 11 MM, 83 MM Long Item Number: 113631
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0666-2022·2022-03-02
Bard SureStep Intermittent Catheter Tray recalled for potential leak defect
C.R. Bard is recalling 2,120 units of the BARD SURESTEP INTERMITTENT CATHETER TRAY (14Fr) due to a potential leak at the catheter-to-drain-bag connection.
Product
BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS14C
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0657-2022·2022-03-02
Medtronic Endurant Stent Graft Systems: Taper Tip Detachment Risk
Certain Medtronic Endurant stent graft systems may have taper tips that detach from the delivery system during implant procedures, potentially requiring secondary surgical intervention.
Product
Endurant, Endurant II and Endurant IIs Stent Graft System: Medtronic Endurant Stent Graft System Model/REF ENBF2313C120EE; ENBF2313C120EE; ENBF2313C145EE; ENBF2313C170EE; ENBF2316C120EE; ENBF2316C145EE; ENBF2316C170EE; ENBF2513C120EE; ENBF2513C145EE; ENBF2513C170EE;
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-0660-2022·2022-03-02
Optima Coil System Recalled for Labeling and Packaging Mix-Up
BALT USA recalls Optima Coil System embolization devices due to labeling/pouch mix-up that could result in incorrect device selection during surgical procedures. Potential harms include vessel damage and aneurysm rupture.
Product
The Optima Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a proximal stainless steel hypo-tube and distal body coil delivery pusher with a radiopaque distal positioning marker and proximal fluorosafe marker. The Optima
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0664-2022·2022-03-02
Stryker Color Cuff tourniquet cuff mislabeled as single-bladder when dual-bladder
Stryker Sustainability Solutions is recalling 40 units of Color Cuff 18" tourniquet cuffs (Lot #12983349) because they are mislabeled as single-bladder when they are actually dual-bladder, creating a risk of incorrect clinical use.
Product
REF: 5921-018-135, Stryker Color Cuff, 18" (Red), Quick Connect Single Port, Single Bladder
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-0656-2022·2022-03-02
Medline Michels Transport Medium Recalled for Improper Storage Conditions
Medline is recalling 2,816 Michels Transport Medium prefilled containers due to improper storage in a temperature-controlled setting instead of refrigeration.
Product
Michels Transport Medium, 20ML Prefilled Cont
Category
Medical Device
Distribution
Distributed nationwide

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12226–12250 of 13837