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

9301–9325 of 13717

HighFDA (Devices)·Z-1682-2023·2023-06-14
BD Veritor System Instructions for Use Not FDA Approved
The Instructions for Use for BD Veritor System rapid diagnostic tests for COVID-19 and flu were not FDA-approved, lacking proper specimen type specifications. Using the test with invalid specimen types could produce false positive or negative results, potentially delaying diagnosis or treatment.
Product
BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B, 30 Single Use Test Devices- Intended for the in vitro, simultaneous qualitative detection and differentiation of SARS-CoV-2 nucleocapsid antigen and influenza A and/or B Catalog Number: 256088
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1686-2023·2023-06-14
SMMT ambIT Kit Basic Filter Luer Cass Recalled for Missing In-Line Filter
Avanos Medical recalls SMMT ambIT Kit Basic Filter Luer Cass units that were distributed without the required air in-line filter component.
Product
SMMT ambIT Kit Basic Filter Luer Cass, Product Code: 220537
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1680-2023·2023-06-14
DePuy Mitek surgical anchor inserter may fracture during use
DePuy Mitek BIOKNOTLESS Rapid surgical anchor inserters may fracture during use, potentially retaining fragments in patients. Removal during surgery may cause bone damage and extended surgical time.
Product
DePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212722
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1689-2023·2023-06-14
TREO Abdominal Stent-Graft Label Does Not Match Actual Device Size
Bolton Medical is recalling the TREO Abdominal Stent-Graft System because the carton label may not match the actual stent-graft size inside. Implanting the wrong size stent-graft could result in surgical complications.
Product
The TREO ABDOMINAL STENT-GRAFT SYSTEM (TREO) consists of four types of implants, specifically a Main Bifurcated Stent-Graft, a Leg Extension Stent-Graft, a Proximal Cuff Stent-Graft and a Straight Iliac Extension Stent-Graft. Each stent-graft is preloaded into its own delivery s
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1690-2023·2023-06-14
Presource Laparoscopy Kit Recalled for Lack of Sterility Assurance
Cardinal Health is recalling Presource Kit laparoscopy surgical packs due to being released without sterility assurance. Affected units may harbor contamination and pose a risk during surgical procedures.
Product
Presource Kit, SMA21LPUHJ GYN Laparoscopy Pack. Convenience kit used for Laparoscopic surgery
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1679-2023·2023-06-14
DePuy Mitek surgical anchor inserter tip may fragment and be retained
DePuy Mitek BIOKNOTLESS Plus surgical anchor inserters may have tips that break off during use and remain in the patient. This could require surgical removal that may cause bone damage.
Product
DePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212726
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1678-2023·2023-06-14
DePuy Mitek BIOKNOTLESS Plus Anchor Inserter Tip May Fracture During Surgery
DePuy Mitek BIOKNOTLESS Plus anchor inserter tips may break and be retained in patients during surgery. Removal of fragments could cause bone damage and prolong surgery time.
Product
DePuy Mitek BIOKNOTLESS Plus w/ Panacryl-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212725
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1691-2023·2023-06-14
Sterile Surgical Procedure Packs Recalled for Defective Light Handle Covers
DeRoyal Industries is recalling 2,972 sterile surgical procedure packs containing light handle covers that have been recalled by another manufacturer. The affected packs were distributed to hospitals in Virginia.
Product
Sterile custom surgical procedure packs: (1) 89-10507.02, TOTAL KNEE PACK, Stonewall Jackson Hospital; (2) 89-10508.02, LOCAL PACK, Stonewall Jackson Hospital; (3) 89-10509.02, LAPAROTOMY PACK, Stonewall Jackson Hospital; (4) 89-10517.04, CNRV BASIC SETUP PACK, New River Va
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1675-2023·2023-06-14
Elekta Unity Image-Guided Radiation Therapy System Electrical Connector Overheating Risk
Elekta, Inc. is recalling 18 Elekta Unity Image-Guided Radiation Therapy Systems due to a potential electrical connector overheat hazard in the MR gradient coil. No injuries have been reported.
Product
Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1676-2023·2023-06-14
Diagnostic Test Recall: 4Kscore Test Software Anomalies May Produce Erroneous Results
BioReference Health is recalling the 4Kscore Test system due to software anomalies in its processing module that may generate erroneous diagnostic results. The recall affects 662 patient test results distributed in New Jersey.
Product
The 4Kscore Test is an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total PSA (prostate specific antigen), Roche Elecsys free PSA, intact PSA, and human kallikrein 2) into a single numerical score that also incorporates the following
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1684-2023·2023-06-14
AVNS ambIT Catheter System Kits Recalled for Missing Air Filter
Avanos Medical recalls some AVNS ambIT System catheter kits that were potentially distributed without an air in-line filter. Affected units were distributed worldwide, including in Texas, Oregon, and Australia.
Product
AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1701-2023·2023-06-14
HydroSil Go Catheters Recalled for Packaging Sterility Risk
C.R. Bard Inc is recalling HydroSil Go Intermittent Urinary Catheters because the resealing label may separate from the foil pouch, potentially compromising product sterility. The recall affects 308,520 devices worldwide.
Product
HydroSil Go Intermittent Urinary Catheters, Catalog Numbers: a) REF 71808, b) REF 71810, c) REF 71812, d) REF 71814, e) REF 71816, f) REF 71818
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1697-2023·2023-06-14
Fluoride Varnish Packaging Error: Wrong Flavor Variant in White Mint Package
Young Dental Manufacturing is recalling Benco Dental iris 5% fluoride varnish packages labeled White Mint because they may contain Bubblegum varnish instead. The recall affects 344 boxes distributed to Florida, Nevada, and Pennsylvania.
Product
BencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-635; cavity varnish
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1694-2023·2023-06-14
ESR Diagnostic Quality Control Material Incorrectly Labeled as Different Level
RR Mechatronics Starrsed Control Level N ESR vials were mislabeled as a different control level, causing instruments to flag results as out of range. The mislabeling affects approximately 9,306 units worldwide.
Product
RR Mechatronics Starrsed Control Level N ESR Control 4.6 ml QRR049001- In-vitro diagnostic quality control material to monitor the precision of Starrsed Erythrocyte Sedimentation Rate (ESR) instruments and procedures. Product Code: A0026577
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1695-2023·2023-06-14
ESR Diagnostic Control Vials Recalled for Incorrect Lot Labeling
Mechatronics USA recalls approximately 10,752 units of ESR quality control vials due to incorrect lot labeling that causes instrument results to be falsely flagged as out of range.
Product
RR Mechatronics Control Level A ESR Control4.6 ml QRR049002- In-vitro diagnostic quality control material to monitor the precision of Starrsed Erythrocyte Sedimentation Rate (ESR) instruments and procedures. Product Code: A0026578
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1696-2023·2023-06-14
Abbott Alinity i Anti-TPO Reagent Kit Recalled for Fill Volume Error
Abbott is recalling Alinity i Anti-TPO Reagent Kit (Lot 46009FN00) due to a manufacturing error resulting in marginally lower fill volume than specified in the Instructions for Use. Approximately 110 kits were distributed nationwide across 17 US states.
Product
Alinity i Anti-TPO Reagent Kit, List Number 09P3521
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1644-2023·2023-06-07
EarlyVue VS30 Vital Signs Monitor lacks calibration alarm, risking inaccurate CO2 readings
Philips EarlyVue VS30 vital signs monitors lack a calibration alarm, potentially causing inaccurate CO2 measurements. This could prevent clinicians from detecting changes in patient condition.
Product
EARLYVUE VS30 VITAL SIGNS MONITOR Software Version A.00.02 and A.00.01 Product Number: 863359
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1654-2023·2023-06-07
Knee Replacement Insert Mislabeled; Contents May Not Match Catalog Number
Howmedica Osteonics Corp. is recalling TRIATHLON X3 knee replacement bearing inserts because products labeled with one catalog number may actually contain a different specification. This mislabeling could result in incorrect implant sizing during surgery.
Product
TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM Intended for knee replacement Catalog Number: 5532-G-413-E
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1648-2023·2023-06-07
Cytrellis ellacor Dermal Micro-Coring System Recalled for Potential Scarring
Cytrellis Biosystems is recalling 89 units of the ellacor System Gen 4 nationwide due to irregular core patterns that may cause prolonged healing, skin texture irregularities, or scarring.
Product
Cytrellis ellacor System with Micro-Coring Technology-Dermal Micro-Coring System System intended for the treatment of moderate and severe wrinkles in the mid and lower face. Model #: Gen 4
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1653-2023·2023-06-07
Knee replacement implant bearing inserts mislabeled with wrong catalog numbers
Howmedica Osteonics recalled 24 TRIATHLON X3 tibial bearing inserts due to mislabeling, where units labeled with one catalog number may contain a different size. Medical facilities should discontinue use and contact the manufacturer.
Product
TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM-Intended for knee replacement Catalog Number: 5531-G-312-E
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1669-2023·2023-06-07
X-Ray Machine Detector May Move Unexpectedly Due to Drive Shaft Failure
FDA recalls the Intelli-C X-Ray machine's left side suspended tabletop model due to potential drive shaft failure in the detector lift mechanism, which could cause uncontrolled detector movement.
Product
Intelli-C, Left side suspended Tabletop, REF: 03400010
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1642-2023·2023-06-07
Venous Hardshell Cardiotomy Reservoirs recalled for sterile packaging defects
Maquet Medical Systems USA is recalling Venous Hardshell Cardiotomy Reservoirs for cardiopulmonary bypass due to sterile packaging defects. Exposure to non-sterile product could result in infection, sepsis, or ischemia.
Product
Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item No. VKMO 10000-USA 701070441 VKMO 11000-USA 701070445
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1640-2023·2023-06-07
QUADROX-i Neonatal oxygenator recalled for compromised sterile packaging
Maquet Medical Systems is recalling QUADROX-i Neonatal oxygenators due to packaging defects that may compromise sterility. Improper accessory placement and packaging damage could expose the device to contamination, risking infection and sepsis.
Product
QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 10000-USA 701070412 HMO 11000-USA 701070416
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1663-2023·2023-06-07
Teleflex HORIZON Titanium ligating clips recalled for missing cartridge safety feature
Teleflex LLC is recalling approximately 146,606 units of HORIZON Microclip Titanium Ligating Clips because a safety feature is missing from the clip cartridge. Without this step feature, clips may be positioned variably and applied inadequately to blood vessels during surgery.
Product
Teleflex HORIZON Microclip Titanium Ligating Clips w/tape, REF 005200; for use in general surgical procedures that require vessel or tissue ligation
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1638-2023·2023-06-07
Cardiac Oxygenator QUADROX-i Adult Recalled for Sterile Barrier Packaging Defects
Maquet is recalling QUADROX-i Adult cardiopulmonary bypass oxygenators (Models HMO 70000-USA and HMO 71000-USA) due to packaging defects including holes, cracks, and improper placement of accessories that may compromise sterility.
Product
QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 70000-USA 701067820 HMO 71000-USA 701067823
Category
Medical Device
Distribution
Distributed nationwide

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9301–9325 of 13717