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-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-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-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
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-1681-2023·2023-06-14
Surgical anchor inserter recalled for potential tip fracture and bone damage
DePuy Mitek BIOKNOTLESS Rapid anchor inserters may fracture during use, potentially leaving fragments in the patient. If detected during surgery, removal could cause bone damage.
Product
DePuy Mitek BIOKNOTLESS Rapid w/ Pan-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212723
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-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-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-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
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
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-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-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
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-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-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-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-1634-2023·2023-06-07
Cardiopulmonary bypass oxygenator recalled due to sterile barrier packaging defects
Maquet Medical Systems USA is recalling 8,670 HMOD 70000-USA/QUADROX-iD Adult oxygenators used in cardiopulmonary bypass due to packaging defects that may compromise sterile barriers and expose devices to contamination.
Product
HMOD 70000-USA/QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Item no. 701067840
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1639-2023·2023-06-07
Maquet QUADROX-i Adult Oxygenator recalled for packaging damage compromising sterile barrier
Maquet Medical Systems is recalling QUADROX-i Adult Oxygenators due to potential packaging damage that may compromise sterile barriers, risking infection during cardiopulmonary bypass surgery.
Product
BEQ-HMO 71000-USA /QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Item no. 701067829
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1668-2023·2023-06-07
Medical Device Recall: X-Ray Detector Drive Shaft May Break
The FDA is recalling 32 X-ray detector units due to a potential drive shaft failure that could cause uncontrolled detector movement. Affected units are distributed in 10 US states.
Product
Intelli-C, Right side suspended Tabletop, REF: 03400000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1641-2023·2023-06-07
QUADROX-i Pediatric Oxygenator Packaging Defects Compromise Sterile Barrier
FDA Class II recall of QUADROX-i Pediatric oxygenators due to packaging defects—creases, holes, cracks—that compromise sterile barriers, risking infection and sepsis during cardiopulmonary bypass procedures.
Product
QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 30000-USA 701070384 HMO 31000-USA 701070388
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-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

How to read this listing

Filters

9301–9325 of 13717