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 13731

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-1687-2023·2023-06-14
Avanos Medical Recalls ambIT Reusable Cassettes Missing Air-Inline Filter
Avanos Medical is recalling SMMT ambIT Reusable cassettes (Product Code 220568, Lot 30191805) that were potentially distributed without a required air-in-line filter. The missing component affects units in Texas, Oregon, and Australia.
Product
SMMT ambIT Reusable Program - Luer Cass, Product Code: 220568
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-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-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-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-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-1685-2023·2023-06-14
AVNS ambIT System infusion kits recalled for missing air filter
Avanos Medical is recalling certain AVNS ambIT System infusion kits because some units may lack the required air in-line filter. Affected kits were distributed worldwide including the US (Texas and Oregon) and Australia.
Product
AVNS ambIT System - PIB/PCA W 5in Cath, Product Code: 220507
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1677-2023·2023-06-14
Surgical Anchor Inserter Tip Fragmentation During Patient Procedures
DePuy Mitek's BIOKNOTLESS Plus anchor inserter may fragment during surgical use if bending force is applied. Fragments retained in the patient may require surgical removal, potentially causing bone damage.
Product
DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212724
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1692-2023·2023-06-14
Surgical Procedure Packs Recalled Due to Included Light Handle Covers
DeRoyal Industries is recalling two models of custom surgical procedure packs because they contain light handle covers that were previously recalled by another manufacturer. The packs were distributed in Virginia.
Product
Sterile custom surgical procedure packs (1) 89-10529.04, CNRV OR C-SECTION PACK, New River Valley Medical Center; and (2) 89-10567.05, OB-OR C-SECTION PACK, Carilion Roanoke Memorial Hospital.
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-1700-2023·2023-06-14
Magic3 Go Pediatric Intermittent Urinary Catheters Recalled for Packaging Defect
C.R. Bard Inc is recalling Magic3 Go pediatric intermittent urinary catheters due to a manufacturing defect where the resealing label can separate from the foil pouch, potentially compromising product sterility.
Product
Magic3 Go Intermittent Urinary Catheters, pediatric Catalog Numbers: a) REF 52810G
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1688-2023·2023-06-14
Avanos Recalls ambIT Cassette Filters for Missing Air In-Line Filter
Avanos Medical is recalling ambIT Cassette Filter Male Luer (Product Code 220266) because some units were potentially distributed without an air in-line filter component.
Product
ambIT Cassette Filter Male Luer, Product Code: 220266
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1698-2023·2023-06-14
Magic3 Go Female Intermittent Urinary Catheters Recalled for Packaging Defect
C.R. Bard Inc is recalling Magic3 Go female intermittent urinary catheters worldwide due to a manufacturing defect where the resealing label can separate from the product pouch, potentially compromising product sterility.
Product
Magic3 Go Intermittent Urinary Catheters, Female Catalog Numbers: a) REF 51808, b) REF 51810, c) REF 51812, d) REF 51814, e) REF 51816, f) REF 51818
Category
Medical Device
Distribution
0 states
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-1699-2023·2023-06-14
Magic3 Go Intermittent Urinary Catheters Recalled for Packaging Defect
C.R. Bard is recalling Magic3 Go Intermittent Urinary Catheters because the clear resealing label can separate from the pouch, potentially compromising sterility. The recall affects devices distributed worldwide.
Product
Magic3 Go Intermittent Urinary Catheters, male Catalog Numbers: a) REF 50810G, b) REF 50812G, c) REF 50814G, d) REF 50816G, e) REF 50818G, f) REF 53810G, g) REF 53812G, h) REF 53814G, i) REF 53816G, j) REF 53818G, k) REF 53820G
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-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-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-1635-2023·2023-06-07
Oxygenator devices recalled due to packaging damage compromising sterile barrier
Maquet Medical Systems USA recalls 15,880 QUADROX-iD oxygenators nationwide due to packaging damage that may compromise sterile barriers, potentially exposing patients to infection.
Product
BEQ-HMOD70000-USA/QUADROX-iD, Oxygenator used during cardiopulmonary bypass Item no. 701067859
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1657-2023·2023-06-07
QUADROX-i Small Adult Oxygenator Recalled Due to Packaging Sterile Barrier Defect
Maquet Medical Systems USA is recalling 1,784 QUADROX-i Small Adult Oxygenators used in heart bypass surgery because product packaging may contain tiny pinholes that compromise sterile integrity, potentially allowing non-sterile exposure.
Product
QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no. BEQ-HMO 50000-USA 701067905 HMO 50000-USA 701067891 HMO 51000-USA 701067895
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

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9301–9325 of 13731