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

12901–12925 of 27721

SevereFDA (Devices)·Z-1614-2024·2024-05-01
Route 92 Medical Reperfusion System Recalled for Potential Device Separation
Nineteen units of the Route 92 Medical 070 Reperfusion System may experience distal tip separation. Healthcare facilities should cease use of affected devices immediately.
Product
Route 92 Medical 070 Reperfusion System, REF 1003, Rxonly, SterileEO. Used for introduction of interventional devices into the neurovasculature and aspiration of thrombus in ischemic stroke patients.
Category
Medical Device
Distribution
30 states
SevereFDA (Drugs)·D-0456-2024·2024-05-01
The GOAT Sublingual Strip Recalled for Undeclared Prescription Drug Ingredients
The GOAT Sublingual Strip male enhancement product, distributed nationwide, was recalled for containing undeclared sildenafil and tadalafil. The product was marketed without FDA approval.
Product
The GOAT SUBLINGUAL STRIP, MALE ENHANCEMENT, 2 Pack, Distributed by Hombres LLC, 130 Maccormick Ave, Suite 105, Costa Mesa, A, UPC 6 61631 26363 1.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0450-2024·2024-05-01
FDA Recalls Flower Power Female Enhancement for Undeclared Sildenafil and Tadalafil
Flower Power CBD infused Female Enhancement contains undeclared sildenafil and tadalafil. These prescription drugs were not disclosed to consumers and the product was marketed without FDA approval.
Product
Flower Power, CBD infused Female Enhancement, 59 ml bottle, UPC 0 678741 351646.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0452-2024·2024-05-01
Pink Pussycat Honey recalled for undeclared sildenafil and tadalafil content
Pyramids Wholesale Inc. is recalling Pink Pussycat Honey because it contains undeclared sildenafil and tadalafil and was marketed without FDA approval. The recall affects all lots nationwide.
Product
Pink Pussycat Honey, net wt: 20gx12 sachets, UPC 7 918750 046557
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0448-2024·2024-05-01
Spanish Fly 22K Capsules Recalled for Undeclared Prescription Drug Ingredients
Spanish Fly 22K capsules contain undeclared sildenafil and/or tadalafil and were marketed without FDA approval. The product poses serious health risks from these unapproved pharmaceutical ingredients.
Product
Spanish Fly 22K capsules, 2-count box, UPC 0 664979 979455
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1613-2024·2024-05-01
Route 92 Medical delivery catheter recalled due to tip separation risk
Route 92 Medical is recalling Tenzing 7 delivery catheters because the distal tip may separate from the proximal marker band. The affected units were distributed across the US and New Zealand.
Product
Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO. Used for introduction of interventional devices into the neurovasculature.
Category
Medical Device
Distribution
30 states
SevereFDA (Drugs)·D-0470-2024·2024-05-01
ForeverMen Natural Energy Boost Capsules Recalled for Undeclared Sildenafil
ForeverMen Natural Energy Boost Capsules contain undeclared sildenafil and are marketed without FDA approval, making them an unapproved drug. Consumers should stop using the product immediately.
Product
ForeverMen Natural Energy Boost Capsules, packaged in a box containing a 10-count blister card.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-1204-2024·2024-05-01
Roly Poly Bakery Multigrain Bread Recalled for Undeclared Egg
Roly Poly Bakery is recalling multigrain bread sold in Connecticut and Massachusetts because it contains undeclared egg, a major food allergen. Consumers with egg allergies should not consume this product.
Product
Roly Poly Bakery brand MULTIGRAIN bread; INGREDIENTS: Whole Wheat Flour, High Gluten Flour, Ryechops, Sesame, Caraway, Brownflex, Soybean, Pearl Wheat, Sunflower, Salt, Water.
Category
Food
Distribution
2 states
SevereFDA (Drugs)·D-0458-2024·2024-05-01
Sexual Enhancement Product Recalled for Undeclared Prescription Drugs
Pyramids Wholesale Inc. is recalling HONEY MANUKA BUNNY LOVE nationwide because it contains undeclared sildenafil and/or tadalafil—prescription medications—and was marketed without FDA approval.
Product
HONEY MANUKA BUNNY LOVE, 12g, All Natural Sexual Enhancement, UPC: N/A
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0454-2024·2024-05-01
FDA Recalls libigrow RED DRAGON+ Capsules for Undeclared Sildenafil and Tadalafil
Pyramids Wholesale Inc. is recalling libigrow RED DRAGON+ capsules nationwide because they contain undeclared sildenafil and tadalafil, prescription medications not approved by the FDA for this product.
Product
libigrow RED DRAGON+, Maximum Strength Formula, 2 capsules per box, UPC 7 05105 83073 5.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0457-2024·2024-05-01
Male Performance Enhancer Recalled for Undeclared Sildenafil and Tadalafil
ALPHASTRIP Male Performance Enhancer strips are being recalled nationwide because they contain undeclared sildenafil and tadalafil. The product was marketed without FDA approval.
Product
ALPHASTRIP MALE PERFORMANCE ENHANCER, The fastest acting sublingual, Serving Size (1 strip), Distributed by: GALT INT'L
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1611-2024·2024-05-01
Route 92 Medical Reperfusion System Potential Catheter Tip Separation
Route 92 Medical recalls its Full Length 070 Reperfusion System due to potential distal tip separation at the proximal marker band, which could affect device delivery during interventional procedures.
Product
Route 92 Medical, Full Length 070 Reperfusion System, REF: 7001, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovasculature.
Category
Medical Device
Distribution
30 states
SevereFDA (Drugs)·D-0453-2024·2024-05-01
Male Sexual Enhancement Product Recalled for Undeclared Pharmaceutical Ingredients
Pyramids Wholesale Inc. is recalling all lots of GoHARD 25000 because it contains undeclared sildenafil and tadalafil. The product was marketed without FDA approval for these prescription-strength drugs.
Product
GoHARD 25000, Male Sexual Enhancement, Honey, 100% Natural, UPC: N/A.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1623-2024·2024-05-01
Hip Implant Acetabular Shell Recalled for Manufacturing Defect
Howmedica Osteonics is recalling TRIDENTII HEMI CLUSTER50D hip implant shells due to excessive deburring that may create a smooth edge, potentially affecting implant fit. Affected units were distributed nationwide and internationally.
Product
TRIDENTII HEMI CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-50D
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0464-2024·2024-05-01
FDA Recalls Fluorescein Sodium Ophthalmic Strips for Manufacturing Defect
The FDA is recalling FUL-GLO Fluorescein Sodium Sterile Ophthalmic Strips (4,648 cartons) nationwide due to unspecified impurities in the active ingredient exceeding USP standards.
Product
FUL-GLO, Fluorescein Sodium Sterile Ophthalmic Strips USP (0.6 mg Fluorescein), 300 sterile strips per carton, Manufactured for: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-403-03.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1618-2024·2024-05-01
Replacement Lead Wires Recalled for Risk of Treatment Delivery Failure
EBI, LLC recalls 829 replacement lead wire assemblies (Part 1067724-2) distributed nationwide since May 1, 2023. Damaged wire sheaths may prevent therapeutic treatment signals from reaching electrodes, potentially delaying treatment.
Product
20" Lead Wires, Replacement Part Number: 1067724-2
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1615-2024·2024-05-01
LightStrike Blackout Curtains Recalled Due to Inadequate UV and Ozone Protection
XENEX LightStrike Blackout Curtains are recalled due to inadequate protection against UV and ozone exposure. Bystanders in rooms during device operation may experience temporary skin reddening, eye irritation, nausea, and headache.
Product
LightStrike Blackout Curtains, Part numbers; 610-00008, 610-00009, 610-00019, 610-00020, and 610-00024, used with the LightStrike Germ-Zapping Robots Models: PXUV4D, PXUV5D, LSMUV6-FT, or LSMUV6-SL, for whole room microbial reduction.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1687-2024·2024-05-01
Water bottles used in dental treatment devices recalled for disassembly risk
Electro Medical Systems is recalling water bottles used with AIRFLOW dental devices because certain bottle collars can disassemble under pressure during treatment or storage. No injuries have been reported.
Product
Brand Name: WATER BOTTLE Product Name: WATER BOTTLE Model/Catalog Number: EG-121 Software Version: N/A Product Description: These bottles are sold empty and are filled by the user with water fort dental treatments. The bottle is pressurized on the device during use. Componen
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1617-2024·2024-05-01
Biomet OrthoPak Bone Growth Stimulator System Recalled Due to Lead Wire Damage
The Biomet OrthoPak Bone Growth Stimulator System is being recalled due to potential lead wire sheath damage that could prevent therapeutic signal delivery and delay patient treatment nationwide.
Product
Biomet OrthoPak Non-invasive Bone Growth Stimulator System-Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones. Part Number: 1067718
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1221-2024·2024-05-01
Blues Hog Sweet & Savory Seasoning recalled for undeclared wheat and soy
Baron Spices Inc is recalling Blues Hog Sweet & Savory Seasoning due to undeclared wheat, soy flour, and soy lecithin. Consumers with wheat or soy allergies should not consume this product.
Product
Blues Hog Sweet & Savory Seasoning, 6.25oz plastic bottle, 12 bottles per case
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-1629-2024·2024-05-01
Hip replacement acetabular shell recalled for excessive deburring
Howmedica Osteonics is recalling TRIDENTII PSL CLUSTER50D acetabular shells for hip replacements due to excessive deburring resulting in smooth edges on the shell.
Product
TRIDENTII PSL CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-50D
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0473-2024·2024-05-01
Cloderm Cream Recalled for Manufacturer Quality Assurance Program Discontinuation
EPI Health is recalling Cloderm cream due to discontinuation of the manufacturer's quality assurance program. This may result in products that do not meet specifications for identity, strength, purity, or quality.
Product
Cloderm (clocortolone pivalate) Cream, 0.1%, Rx Only, For Topical Use Only, Net Wt 45g, Manufactured for: EPI Health, LLC, Charleston, SC 29403, NDC 71403-804-90
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1636-2024·2024-05-01
Quidel InflammaDry MMP-9 Test: Misaligned Results Window May Cause False Negatives
Quidel Corporation is recalling 104,300 units of InflammaDry MMP-9 diagnostic tests due to misalignment of the test results window. Positive results may be hidden and not visible, potentially leading to false negative readings.
Product
QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 20 Tests
Category
Medical Device
Distribution
44 states
HighFDA (Devices)·Z-1607-2024·2024-05-01
Vanguard Knee System Tibial Bearing Recalled for Manufacturing Damage
Biomet is recalling the Vanguard Knee System AS Tibial Bearing (Model 189082) due to possible damage during manufacturing. Affected units were distributed worldwide including the United States.
Product
Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number 189082. The product is placed into a foil pouch with protective packaging in the form of a polyurethane bag, and sealed closed (inner barrier). The inner barrier is then placed into a PETG tray and
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1635-2024·2024-05-01
Palindrome Precision H Chronic Catheter Kit may lack labeled heparin coating
Covidien is recalling 878 units of Palindrome Precision H Chronic Catheter Kits that may lack the heparin anticoagulant coating indicated on the label, potentially reducing clot prevention during hemodialysis.
Product
Palindrome Precision H Chronic Catheter Kit 14.5 Fr/Ch (4.8mm) x 23 cm (Symmetrical Tip, Heparin Coating and Tal VenaTrac Stylet- Intended for acute and chronic hemodialysis, apheresis, and infusion. Model Number (CFN): 8888145044CP
Category
Medical Device
Distribution
Distributed nationwide

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12901–12925 of 27721