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

11076–11100 of 27647

HighFDA (Devices)·Z-2686-2024·2024-08-28
Diagnostic Test Kit May Produce False Results in Tuberculosis Drug Resistance Testing
The BD BACTEC MGIT 960 PZA Kit may intermittently produce falsely resistant results when testing TB susceptibility to pyrazinamide. This Class II recall affects 12,383 units distributed worldwide.
Product
BD BACTEC MGIT 960 PZA Kit)- IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA) Catalog Number: 245128
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2581-2024·2024-08-28
Baxter Spectrum Wireless Battery Modules May Fail to Document Infusion Status
Baxter Spectrum Wireless Battery Modules may fail to automatically transmit infusion status information to hospital electronic medical records systems. The software issue affects 17,377 units nationwide.
Product
Baxter Spectrum Wireless Battery Modules A/B/G/N, product code 35223, used with either of the following: 35700BAX2 (Spectrum V8 infusion pump) or 3570009 (Spectrum IQ infusion pump) Baxter SIGMA Spectrum V8 Infusion Pump
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2664-2024·2024-08-28
Ophthalmic knife sharpness defect recalled for increased complaints
Alcon recalls 3,419 ophthalmic knives due to increased complaints about blade sharpness. The Class II recall affects the ClearCut SB INTREPID 2.2 ANG and related models distributed nationwide and internationally.
Product
Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog Number: 8065992561 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2641-2024·2024-08-28
Bottle Decanter REF 2004S Recalled for Sterile Barrier Packaging Defects
Microtek Medical Inc. is recalling Bottle Decanter REF 2004S units due to pin holes and tears found in the sterile barrier packaging during testing. Compromised packaging could allow contamination of the medical device.
Product
Bottle Decanter, REF 2004S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2657-2024·2024-08-28
ClearCut Sideport Ophthalmic Knives Recalled Due to Sharpness Issues
Alcon has recalled ClearCut Sideport Knife ophthalmic surgical instruments due to an increase in complaint reports related to sharpness.
Product
Product Desc: Product Name: ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065921541 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2640-2024·2024-08-28
Bag Decanter II Medical Device Recalled for Sterile Packaging Defects
Microtek Medical Inc. is recalling Bag Decanter II medical devices due to pinholes and tears identified in the sterile packaging film during quality testing, which could compromise product sterility.
Product
Bag Decanter II, REF 2002S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2648-2024·2024-08-28
Alcon ophthalmic surgical knives recalled for blade sharpness defects
Alcon is recalling specific ophthalmic surgical knives (ClearCut and A-OK models) from its Custom Pak system due to blade sharpness complaints affecting 384,851 units distributed nationwide and internationally.
Product
Product Name: Alcon Custom Pak Model/Catalog Number: Many Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2663-2024·2024-08-28
Alcon Ophthalmic Surgical Knives Recalled Due to Sharpness Defects
Alcon is recalling ClearCut SB INTREPID 2.2 ANG ophthalmic surgical knives due to increased complaint reports about inadequate blade sharpness. The recall affects 35,199 units distributed across the United States and 41 other countries.
Product
Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog Number: 8065992445 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0639-2024·2024-08-28
Rubbing Alcohol Recalled for Non-Sterile Water in Manufacturing
ZEE Company's 70% isopropyl rubbing alcohol is being recalled because non-sterile water was used in production instead of sterile water, violating manufacturing standards. The product was distributed nationwide in the US and Canada.
Product
Rubbing Alcohol (70% Isopropyl Alcohol), First-Aid Antiseptic, packaged in a) 3.78L (1-gallon jug); and b) 208.19L (55-gallon drum), Sold by: ZEE Company- A Member of the Vincit Group, 3401 Cummings Road, Chattanooga, TN 37419, Made in USA.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2671-2024·2024-08-28
Ophthalmic Surgical Knives Recalled Due to Sharpness Defect
Alcon is recalling 7,713 units of ClearCut and A-OK ophthalmic surgical knives due to reports of decreased sharpness. The defect may compromise surgical performance during eye procedures.
Product
Product Name: 25+ TOTALPLUS CP PAK 20K CPM BV .9 IU Model/Catalog Number: 8065000095 Software Version: N/A Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2693-2024·2024-08-28
IBA Proton Therapy System PROTEUS 235 Collision Detection Malfunction
FDA recalls 19 units of the IBA Proton Therapy System PROTEUS 235 due to occasional failures in collision detection for the Forte Robotic Patient Positioning System affecting facilities across multiple US states and internationally.
Product
IBA Proton Therapy System - PROTEUS 235- Designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-2684-2024·2024-08-28
VITROS XT Chemistry Slides Recalled for Dust Contamination of Diagnostic Results
Ortho-Clinical Diagnostics is recalling 88,253 units of VITROS XT Chemistry ALB-TP Slides because they shed dust and debris during normal operation, potentially contaminating sodium test results and causing misdiagnosis.
Product
The VITROS XT Chemistry Products ALB-TP Slides is a single device that contains both an albumin test and a total protein test side by side separated by a plastic barrier sealed within a single slide frame. In this format, individual reactions occur, and test results are generated
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2658-2024·2024-08-28
Alcon ClearCut and A-OK Ophthalmic Knives Recalled for Reduced Sharpness
Alcon is recalling ClearCut Sideport and A-OK Corneal/Scleral V-Lance ophthalmic knives due to reports of reduced blade sharpness. The recall affects 6,020 units distributed in the United States and internationally.
Product
Product Desc: Product Name: ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065982465 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2676-2024·2024-08-28
Ophthalmic surgical knives recalled for blade sharpness defect
Alcon Research LLC is recalling 7,108 ClearCut and A-OK ophthalmic surgical knives due to increased complaint reports about blade sharpness. The affected knives were distributed nationwide and internationally.
Product
Product Name: TOTAL PLUS,25+,10K VALVE STD Model/Catalog Number: 8065752437 Software Version: N/A Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2652-2024·2024-08-28
Alcon Ophthalmic Surgical Knives Recalled for Inadequate Sharpness Defect
Alcon is recalling specific ophthalmic knives due to reports of inadequate sharpness. The affected instruments may not function as intended during surgical procedures.
Product
Product Desc: Product Name: CLEARCUT SAFETY INTREPID SB,2.4 Model/Catalog Number: 8065772445 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2701-2024·2024-08-28
Medline medical procedure kits recalled for dimensional variation
Medline is recalling medical procedure kits due to a slight dimensional variation that may cause fitting difficulties. No injuries or illnesses have been reported.
Product
Medline medical procedure kits labeled as follows: a) HEART ANESTHESIA SET UP, REF DYNJ902752C, b) KIT ENDO, REF DYKE1872A, c) LOWER ENDO KIT, REF DYKE1921A, d) PACEMAKER, REF DYNJ901681D, e) UPPER ENDO KIT, REF DYKE1922A, f) VASCULAR, REF DYNJ905515D, g) VASCUALR,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0637-2024·2024-08-28
Testosterone Gel Recalled by Teva for Excessive Potency
Teva Pharmaceuticals recalls 7,080 packets of Testosterone Gel nationwide due to higher-than-labeled potency. Patients using the recalled product may receive unintended overdoses.
Product
TESTOSTERONE — TESTOSTERONE (TESTOSTERONE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2683-2024·2024-08-28
FDA Recalls BioFire Pneumonia Diagnostic Test Kits for Control Failures
BioFire Diagnostics recalls BIOFIRE FILMARRAY Pneumonia Panel plus test kits due to manufacturing defects that could lead to control failures and delayed test results. The affected kits were distributed in multiple US states and countries worldwide.
Product
BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2715-2024·2024-08-28
NeuroLogica GM60A Mobile X-Ray System Anti-Fall Arm Safety Failure Risk
NeuroLogica has recalled its GM60A Digital Diagnostic Mobile X-Ray System due to potential failure of the anti-fall safety system in the device arm. The recall affects 31 units distributed nationwide.
Product
GM60A. Digital Diagnostic Mobile X-Ray System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2703-2024·2024-08-28
Medline medical procedure kits recalled for dimensional variation affecting canister fit
Medline Industries recalled 6,998 medical procedure kits worldwide due to slight dimensional variations that may cause difficulty fitting into outer canisters. The Class II recall affects multiple procedure kit types distributed in the US and internationally.
Product
Medline medical procedure kits labeled as follows: a) BASIC NASAL, REF DYNJ909932; b) BRONCH KIT, REF DYKE1007B; c) ENT, REF DYNJ909935; d) NASAL SINUS-LF, REF DYNJ902624G; e) ORAL, REF DYNJ902377I; f) PACK,BRONCHOSCOPY, REF DYNJ65475B; g) PACK,HEAD AND NECK, REF
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2705-2024·2024-08-28
Medline ENDO KIT procedure kits recalled for dimensional variation affecting fit
Medline is recalling 2,588 ENDO KIT medical procedure kits worldwide due to dimensional variation that may cause difficulty fitting into the outer canister.
Product
Medline medical procedure kits labeled as follows: a) ENDO KIT, REF DYK1012268E1
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2678-2024·2024-08-28
Alcon ophthalmic surgical knives recalled for sharpness defects
Alcon is recalling ClearCut and A-OK ophthalmic surgical knives due to sharpness complaints. The defect affects 1,057 units distributed nationwide and internationally.
Product
Product Name: 25+ CMB PAK 10K CPM,V,STD 0.9 Model/Catalog Number: 8065752450 Software Version: N/A Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2653-2024·2024-08-28
Ophthalmic Surgical Knives Recalled for Potential Sharpness Issues
Alcon is recalling specific ophthalmic knives following an increase in complaint reports related to sharpness. These surgical instruments are used in eye procedures.
Product
Product Desc: Product Name: CLEARCUT SAFETY INTREPID DB,2.4 Model/Catalog Number: 8065772465 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2688-2024·2024-08-28
Barricaid Annular Closure Impactor recalled due to missing welds
Intrinsic Therapeutics recalls 207 units of Barricaid Annular Closure Impactor devices nationwide due to manufacturing defects where at least two units are missing critical welds.
Product
Barricaid Annular Closure Impactor, REF: BAR-IMPACTOR, P/N: 400906-A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2582-2024·2024-08-28
Spectrum Wireless Battery Modules fail to auto-document infusion status
Spectrum Wireless Battery Modules may fail to send infusion status updates to hospital electronic medical records. The issue affects 17,377 units nationwide used with Spectrum V8 and IQ infusion pumps.
Product
Spectrum Wireless Battery Modules A/B/G/N, product code 36010, used with either of the following 35700BAX2 (Spectrum V8 infusion pump) and 3570009 (Spectrum IQ infusion pump)
Category
Medical Device
Distribution
Distributed nationwide

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11076–11100 of 27647