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

9501–9525 of 113902

ModerateFDA (Devices)·Z-1715-2025·2025-05-07
Olympus SOLTIVE Pro SuperPulsed Laser System procedural parameter issue
Olympus is recalling the SOLTIVE Pro SuperPulsed Laser System because preset treatment parameters may not be consistently applied according to the instructions for use.
Product
Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Numbers: TFL-SLS, TFL-PLS Product Description: SOLTIVE Laser Systems use technology to increase procedural efficiency and flexibility to ureteroscopy, PCNL, and poten
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0760-2025·2025-05-07
Emily Kate's Gluten Free Carrot Cake recalled for foreign material
Emily Kate's Gluten Free Carrot Cake (6.4 oz) is being recalled because foil has been found in cake slices. The affected product was distributed to one location in Wisconsin.
Product
Emily Kate's Gluten Free Carrot Cake, Net Wt. 6.4oz, Emily Kate's Food, LLC, Kansas City, KS 66106, UPC 850581007284
Category
Food
Distribution
1 state
ModerateFDA (Devices)·Z-1692-2025·2025-05-07
Defibtech Automated External Defibrillators Model DDU-2300 Recalled
Defibtech is recalling Automated External Defibrillators Model DDU-2300 distributed in Switzerland because Italian-language labeling and instructions were not included, violating Swiss Medical Devices Ordinance requirements.
Product
Automated External Defibrillators, Model DDU-2300. Item numbers: DCF-E2310D3/1¿(German/English dual language), DCF-E2310E3/1¿(German/French dual language), DCF-E2310F3/1¿ (French/English dual language), DCF-E2310G3/1¿(French/German dual language), DCF-E2310IT (Italian language)
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1685-2025·2025-05-07
epoc BGEM Crea Test Card for Blood Analysis System recalled
Siemens Healthcare Diagnostics is recalling epoc BGEM Crea Test Card (25 pk) units due to discrepant high pH results in samples with higher injection volumes. The recall affects 5,207 units distributed nationwide and internationally.
Product
epoc BGEM Crea Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736382; epoc Software Version & Sensor Configuration: epoc Host SW v3.41.2, epoc NXS SW v4.14.9 & 4.14.11, Sensor Configuration 45.n.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0393-2025·2025-05-07
Wegovy injection recalled due to temperature exposure during shipping
Cardinal Health is recalling Wegovy (semaglutide) 2.4 mg injection due to temperature abuse during shipping. Product was removed from refrigerated storage for an extended period due to a distribution center error.
Product
Wegovy (semaglutide) injection, 2.4 mg/0.75 mL, 4 Single-Dose Prefilled Pens per Carton, For Subcutaneous Use Only, Rx Only, Single-Dose Only, Novo Nordisk Inc., Plainsboro, NJ 08536, Manufactured by: Novo Nordisk A/S, DK-2880, Bagsvaerd, Denmark, NDC 0169-4524-14.
Category
Drug
Distribution
3 states
ModerateFDA (Devices)·Z-1689-2025·2025-05-07
IceSeed 1.5 CX Cryoablation Needles Recalled for Incorrect Software Settings
Boston Scientific is recalling IceSeed 1.5 CX cryoablation needles manufactured between April 2024 and February 2025 due to incorrect software programming. Affected needles may prompt unnecessary Needle Integrity and Functionality Tests if disconnected and reconnected during use.
Product
IceSeed 1.5 CX NEEDLE OUS, Cryoablation Needle, REF H7493967534170. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1683-2025·2025-05-07
HistoCore PELORIS 3 Rapid Tissue Processor Manifold Tubing Leakage
Leica Biosystems is recalling 77 units of the HistoCore PELORIS 3 Rapid Tissue Processor due to a leakage issue in the manifold tubing. The affected units were distributed across 14 US states.
Product
HistoCore PELORIS 3, Model/Catalog Number: 45.0005/45.7512.501 A11, Software Version: 3.4.0. The HistoCore PELORIS 3 Rapid Tissue Processor is a dual retort rapid tissue processor used to prepare tissue samples.
Category
Medical Device
Distribution
14 states
ModerateFDA (Devices)·Z-1712-2025·2025-05-07
Medline Sterile Water and Saline Bottles Recalled for Leaking Peel-Foil Seals
Medline procedure kits containing Sterile Water and Sterile 0.9% Normal Saline bottles are being recalled because the bottles leak at the peel-foil and bottle opening interface.
Product
Medline procedure kits, labeled as: REDDY JOINT BATH, REF MMJB001A
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1693-2025·2025-05-07
Automated External Defibrillator Model DDU-2450 Missing Italian Translation
Defibtech, LLC is recalling one Automated External Defibrillator Model DDU-2450 (German language version) distributed in Switzerland because it lacks required Italian language labeling and instructions for use.
Product
Automated External Defibrillators, Model DDU-2450. Item number: DCF-E2460DE (German language)
Category
Medical Device
Distribution
0 states
ModerateFDA (Drugs)·D-0395-2025·2025-05-07
Levothyroxine Sodium Tablets 50 mcg Recalled for Subpotency
Accord Healthcare is recalling 4,872 bottles of Levothyroxine Sodium Tablets (50 mcg) nationwide because the tablets are subpotent and may not provide the intended therapeutic effect.
Product
LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1686-2025·2025-05-07
IceSeed 1.5 CX S Cryoablation Needle Programmed with Incorrect Settings
Boston Scientific is recalling 435 IceSeed 1.5 CX S cryoablation needles manufactured between April 2024 and February 2025 that were programmed with DEMO settings instead of Commercial settings, which can cause the Cryoablation System to prompt repeated tests if the needle is disconnected and reconnected.
Product
IceSeed 1.5 CX S NEEDLE US, Cryoablation Needle, REF H7493967233100. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0394-2025·2025-05-07
Levothyroxine Sodium Tablets Recalled for Subpotency by Accord Healthcare
Accord Healthcare is recalling 4,888 bottles of Levothyroxine Sodium Tablets (25 mcg) nationwide due to subpotency. The affected lot is D2300323 with expiration date 01/2026.
Product
LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1703-2025·2025-05-07
myQA iON dosimetry device analysis result miscalculation issue
IBA Dosimetry GmbH is recalling the myQA iON dosimetry device (Article Number MQ10-000) because creating two structures with identical names except for a special character causes wrong analysis results.
Product
myQA iON; Article Number: MQ10-000;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0389-2025·2025-05-07
Tirofiban Injection Recalled for Out-of-Specification Test Results
Eugia US LLC is recalling Tirofiban Hydrochloride Injection due to out-of-specification test results for related substances found during stability testing. The affected lot was distributed nationwide.
Product
TIROFIBAN — TIROFIBAN (TIROFIBAN)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1687-2025·2025-05-07
Boston Scientific IceSeed CX Cryoablation Needles Incorrectly Programmed
Boston Scientific is recalling IceSeed 1.5 CX S cryoablation needles manufactured April 2024 to February 2025 that were programmed with DEMO instead of Commercial settings. If disconnected and reconnected after initial testing, the system will re-prompt testing rather than functioning normally.
Product
IceSeed 1.5 CX S NEEDLE OUS, Cryoablation Needle, REF H7493967334100. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0397-2025·2025-05-07
Levothyroxine Sodium Tablets Nationwide Recall Due to Subpotency
Accord Healthcare is recalling approximately 18,984 bottles of Levothyroxine Sodium Tablets, 112 mcg, nationwide because the tablets are subpotent. Patients taking this medication should contact their pharmacy or healthcare provider immediately.
Product
LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1706-2025·2025-05-07
Medline Sterile 0.9% Normal Saline 100mL bottles recalled for leaks
Medline Sterile 0.9% Normal Saline 100mL bottles are being recalled because they may leak at the interface where the peel-foil meets the bottle opening. The bottles were distributed nationwide in the US and in Panama and Canada.
Product
Medline Sterile 0.9% Normal Saline, USP, 100mL, REF RDI30296
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1707-2025·2025-05-07
Medline procedure kits recalled for leaking sterile water and saline bottles
Medline procedure kits containing sterile water and 0.9% normal saline bottles are being recalled because the bottles leak at the peel-foil and bottle opening interface. The kits were distributed worldwide including the US, Panama, and Canada.
Product
Medline procedure kits, labeled as: T AND A PACK -LF, REF DYNJ85792
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0746-2025·2025-05-07
Chile Verde Egg Bites recalled for potential foreign material contamination
Valley Fine Foods Co., Inc is recalling Chile Verde Egg Bites due to potential contamination with foreign materials. Affected products were distributed in Texas.
Product
CHILE VERDE EGG BITES; NET WT. 4.6 OZ (130 g); 2 egg bites/package
Category
Food
Distribution
1 state
ModerateFDA (Devices)·Z-1705-2025·2025-05-07
Medline Sterile Water USP bottles recalled for leaking at peel-foil interface
Medline Sterile Water, USP 100mL bottles are being recalled because they leak at the interface between the peel-foil and bottle opening, posing a contamination risk.
Product
Medline Sterile Water, USP, 100mL, REF RDI30295
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0400-2025·2025-05-07
Medroxyprogesterone Acetate Injectable Suspension Recalled Due to Cold Chain Disruption
Medroxyprogesterone Acetate Injectable Suspension (150 mg/mL) distributed to medical facilities in Mississippi and Florida is recalled because severe thunderstorms caused shipping delays that may have compromised the product's storage conditions and safety.
Product
Medroxyprogesterone Acetate Injectable Suspension, USP, 150 mg / mL, 1 mL Single-Dose Vial, Rx only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520, NDC 55150-0330-01
Category
Drug
Distribution
2 states
ModerateFDA (Drugs)·D-0392-2025·2025-05-07
Dexonto 0.4% Dexamethasone Solution Recalled for Incorrect Expiration Dating
Nubratori, Inc. is recalling Dexonto 0.4% dexamethasone sodium phosphate solution because some outer boxes are labeled with an incorrect expiration date (12/25/2025 instead of 12/25/2024), creating risk of use after actual expiration.
Product
Dexonto 0.4% (dexamethasone sodium phosphate) solution 20 mg/5 mL (4 mg/mL), Rx Only, 12 - 5 mL Single Dose Units per box, Preservative Free, For Iontophoresis Use Only, Non-Sterile Product, Not for Injection, NUBRATORI RX, 381 Van Ness Ave# 1507, CA 90501, NDC 71300-6564-1 (box)
Category
Drug
Distribution
2 states
ModerateFDA (Drugs)·D-0401-2025·2025-05-07
Infuvite Adult Multiple Vitamins Injection Recalled Due to Cold Chain Failure
Certain Infuvite Adult injectable vitamins were exposed to inadequate storage conditions after severe thunderstorms caused shipping delays exceeding 48 hours. The affected products' safety, quality, and potency may have been compromised.
Product
INFUVITE ADULT — INFUVITE ADULT (MULTIPLE VITAMINS INJECTION)
Category
Drug
Distribution
2 states
ModerateFDA (Devices)·Z-1710-2025·2025-05-07
Medline Plastics Suture Tray recalled due to leaking sterile liquid bottles
Medline is recalling Plastics Suture Tray kits (Ref SUT13535) because the included Sterile Water and Sterile 0.9% Normal Saline bottles leak at the peel-foil and bottle opening interface.
Product
Medline procedure kits, labeled as: PLASTICS SUTURE TRAY, REF SUT13535
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1713-2025·2025-05-07
Medline Sterile Water and Saline Bottles Recalled for Leaking
Medline Industries is recalling Sterile Water and Sterile 0.9% Normal Saline bottles due to leaking at the peel-foil and bottle opening interface. The affected kits were distributed nationwide and internationally.
Product
Medline procedure kits, labeled as: OL OCULAR, REF DYNJ906183K
Category
Medical Device
Distribution
Distributed nationwide

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9501–9525 of 113902