FDA Recalls

The latest food, drug and medical device recalls reported by the U.S. Food and Drug Administration, newest first. Data updated Oct 21, 2026.

87,918 recalls · page 6 of 30

Class IIDeviceOngoing
ABD HYSTERECTOMY; Model/Item Number (Kit): NAMC438-07;
AVID Medical, Inc. · Toano, VA

Product may be potentially contaminated with a lubricant used during the manufacturing process.

Class IIIDeviceOngoing
BeneVision N1 and N-Series Patient Monitor. Patient Monitor: N12/N15/N17/N19/N22.
Mindray DS USA, Inc. · Mahwah, NJ
Class IIDeviceOngoing
GYN LAPAROSCOPY/LAPAROTOMY; Model/Item Number (Kit): 1. WRNM002-15, 2. FBCH108-03;
AVID Medical, Inc. · Toano, VA
Class IIIDeviceOngoing
Generic Name: Kit, Urine, Clean Catch Trade Name: Kit: Urinary Clean Catch 20/cs Model/Catalog Number: 76769 Lot Number: 333606 UDI-DI: 20809160118228 Software Version: N/A
Medical Action Industries, Inc. 306 · Arden, NC
Class IIDeviceOngoing
MAJOR PACK; Model/Item Number (Kit): NIHB0018-11;
AVID Medical, Inc. · Toano, VA
Class IIIDeviceOngoing
Panorama and Telemetry Monitoring System. Operator's Manuals: TMS-6016/Panorama Telepack-608/TMS60 (TD60).
Mindray DS USA, Inc. · Mahwah, NJ
Class IIDeviceOngoing
Presource Packs containing Medtronic Microstream Components: Intubation Kit Catalog Numbers AN23366084 AN23366085 AN2336608H AN2336608J Intubating Bag Kit Catalog Number OMSVM4166A Intubation UH Kit Catalog Number AN2336608G
Class IIDeviceOngoing
DxC 500i Clinical Analyzer Modules: 1. DxC 500 AU Module w/ISE, DxC 500i, Part No. C63522 2. DxC 500 AU Module, DxC 500i, Part No. C63521 3. Access 2 Module, DxC 500i, Part No. C13252
Class IIDeviceOngoing
SEDIPLAST; Model/Catalog Numbers: S-100 and S-1000;
POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC · Cortlandt Manor, NY
Class IIDeviceOngoing
DAVINCI LAP/GYN; Model/Item Number (Kit): WRNM037-16;
AVID Medical, Inc. · Toano, VA
Class IIIDeviceOngoing
BeneVision Series Telemetry Monitor. Operator's Manuals: TM70/TM80
Mindray DS USA, Inc. · Mahwah, NJ
Class IIDeviceOngoing
ENDOVASCULAR PACK; Model/Item Number (Kit): VAPX014-04;
AVID Medical, Inc. · Toano, VA
Class IIDeviceOngoing
HALYARD Laparoscopy Comprehensive Pack II REF: 49332
GRI Medical & Electronic Technology Co., Ltd. · Jia Xing, N/A
Class IIDeviceOngoing
Alphenix INFX-8000C/B5
Canon Medical System, USA, INC. · Tustin, CA
Class IIDeviceOngoing
DxC 500 AU Clinical Chemistry Analyzers: 1. AU w/out ISE, Part No. C63519 2. AU w/ISE, Part No. C63520
Beckman Coulter Inc. · Brea, CA
Class IIIDeviceOngoing
cPM Series Patient Monitor. Operator's Manual: cPM 8/cPM 12
Mindray DS USA, Inc. · Mahwah, NJ
Class IIIDeviceOngoing
BeneView Series. Operator's Manuals: T5 / T8
Mindray DS USA, Inc. · Mahwah, NJ
Class IIDeviceOngoing
LAPAROSCOPIC PROSTATECTOMY; Model/Item Number (Kit): NIHB0036-07;
AVID Medical, Inc. · Toano, VA
Class IIDeviceOngoing
Brand Name: ADAPTABLE Beach Chair Product Name: Beach Chair surgical patient positioner Model/Catalog Number: 804-33-300 (Enovis); 3105-400-030 (Stryker); internal BC-0001 / BC-0220 Software Version: N/A Product Description: Surgical beach-chair positioner that mounts to the accessory rails of the OR table leg section to elevate and support the patient's upper body in the upright (beach chair) position during surgical procedures. Component: No, finished device. The failure is in the BC-0105, subcomponent.
Class IIDeviceOngoing
Intellijoint Navigation System: Workstation G2 Configured, REF: 000-0241; Intellijoint HIP Cart System, REF: 000-0250; Intellijoint HIP, Portable System, REF: 000-0249
Intellijoint Surgical, Inc. · Kitchener, N/A
Class IIDeviceOngoing
Sperm Ab ELISA; Model/Catalog Number: EIA-1826; Product Description: Sperm Ab ELISA (96 well plate test);
DRG International, Inc. · Springfield, NJ
Class IIIDeviceOngoing
T1 Patient Monitor. Operator's Manual: T1 Patient Monitor
Mindray DS USA, Inc. · Mahwah, NJ
Class IIDeviceOngoing
TufTex¿ Over-the-Wire Embolectomy Catheter; Catalog Number: E1651-88;
LeMaitre Vascular, Inc. · Burlington, MA
Class IIDeviceOngoing
PACK OPEN HEART CFH; Model/Item Number (Kit): 1. UFCF004-06, 2. UFCF004-07;
AVID Medical, Inc. · Toano, VA
Class IIDeviceOngoing
HEART PREP TRAY; Model/Item Number (Kit): MECV97W;
AVID Medical, Inc. · Toano, VA
Class IIIDeviceOngoing
Passport Series Patient Monitor. Operator's Manuals: 8 / 12 / 12M / 17M / V
Mindray DS USA, Inc. · Mahwah, NJ
Class IIDeviceOngoing
PLASTICS TRAY; Model/Item Number (Kit): EURO053;
AVID Medical, Inc. · Toano, VA
Class IFoodOngoing
Todd's Seeds Salad Sprouting Mixture - Broccoli, Mustard, Alfalfa and Cabbage, packaged in heat-sealed resealable bags in the following sizes: 1/4 lb., 1/2 lb., and 1 lb.
Class IIFoodOngoing
Lior brand Cinnamon Ground Seasoning; 90g transparent plastic container; UPC 794711005484.
Galil Importing Corp · Hauppauge, NY
Class IIFoodOngoing
Kofinas Garlic Mediterranean Infused Extra Virgin Olive Oil, packaged in 3.4 fl oz (100mL), 8.5 fl oz (250mL), and 17 fl oz (500mL) glass bottles, UPC: 799475717185 (on 8.5 fl oz/250mL), 799475717178 (on 17 fl oz/500mL). The 3.4 fl oz/100mL bottles were sold as part of a gift set; the 8.5 fl oz/250mL and 17 fl oz/500mL products were sold individually.
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Source: openFDA enforcement reports. Not for medical decisions; data may be incomplete or unvalidated.

Reported Oct 14, 2026 · Z-0106-2027

Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions

Reported Oct 14, 2026 · Z-0110-2027

Product may be potentially contaminated with a lubricant used during the manufacturing process.

Reported Oct 14, 2026 · Z-0093-2027

An internal data-entry error caused kit lot 333606 to be labeled with an expiration date of March 31, 2027, instead of February 28, 2027.

Reported Oct 14, 2026 · Z-0069-2027

Product may be potentially contaminated with a lubricant used during the manufacturing process.

Reported Oct 14, 2026 · Z-0104-2027

Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions

Reported Oct 14, 2026 · Z-0112-2027

Cardinal Health 200, LLC · Waukegan, IL

Kits contain Microstream components. Medtronic issued an update to the Instructions for Use of these components due reports of difficulty in disconnecting the adapter from the patient's endotracheal tube to perform a procedure. The issue can result in a delay to treatment and unintended extubation. The potential exists for respiratory failure, hypoxia, aspiration, or low oxygen saturation.

Reported Oct 14, 2026 · Z-0079-2027

Beckman Coulter Inc. · Brea, CA

Beckman Coulter has identified a software issue affecting DxC 500i Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical Chemistry test to use units different from the system default, a subsequent configuration change and activation of the draft configuration in the System Configuration page may cause the analyzer to revert the test units to the system default setting without notifying the user. The system does Pre-Review Reminders Include OII and CDRHRecallGroup@fda.hhs.gov in any discussions on change/elevation of recalls to Class I classification and situations involving additional public communications (FDA and/or firm issued). Post-Review Reminders Final Check: Ensure your documentation accurately reflects the final recommendation prior to signature. Complete CTS: Recall Product tab, Additional Recall Event Info, Regulation, and Act. Upload PDFs of Consult, Review Memo, and Classification Letter for Class I Recall in DocMan. [Click to enter extra reminder]To add reminders, type the reminder in the text field to the left then press the Tab key. Doc ID 03534.05.06 2 of 8 not provide a warning or notification to alert the user that the configured units have reverted to the default units. This issue can result in falsely elevated reported results.

Reported Oct 14, 2026 · Z-0083-2027

During use of an affected tube, the operator may encounter increased resistance when inserting the pipette. The resulting pressure buildup may cause the tube cap to detach or be forcibly ejected, potentially resulting in the release of blood and exposure of the operator or surrounding work area to a biological hazard (blood).

Reported Oct 14, 2026 · Z-0107-2027

Product may be potentially contaminated with a lubricant used during the manufacturing process.

Reported Oct 14, 2026 · Z-0101-2027

Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions

Reported Oct 14, 2026 · Z-0111-2027

Product may be potentially contaminated with a lubricant used during the manufacturing process.

Reported Oct 14, 2026 · Z-0095-2027

Laparoscopy packs labeled as "latex free" were found to contain a latex urethral catheter

Reported Oct 14, 2026 · Z-0077-2027

Loosening of the bolts securing the longitudinal movement mechanism may cause the tabletop to shift, resulting in [positional/imaging/patient] misalignment and a longitudinal motion error

Reported Oct 14, 2026 · Z-0108-2027

Beckman Coulter has identified a software issue affecting DxC 500 AU Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical Chemistry test to use units different from the system default, a subsequent configuration change and activation of the draft configuration in the System Configuration page may cause the analyzer to revert the test units to the system default setting without notifying the user. The system does Pre-Review Reminders Include OII and CDRHRecallGroup@fda.hhs.gov in any discussions on change/elevation of recalls to Class I classification and situations involving additional public communications (FDA and/or firm issued). Post-Review Reminders Final Check: Ensure your documentation accurately reflects the final recommendation prior to signature. Complete CTS: Recall Product tab, Additional Recall Event Info, Regulation, and Act. Upload PDFs of Consult, Review Memo, and Classification Letter for Class I Recall in DocMan. [Click to enter extra reminder]To add reminders, type the reminder in the text field to the left then press the Tab key. Doc ID 03534.05.06 2 of 8 not provide a warning or notification to alert the user that the configured units have reverted to the default units. This issue can result in falsely elevated reported results.

Reported Oct 14, 2026 · Z-0084-2027

Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions

Reported Oct 14, 2026 · Z-0115-2027

Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions

Reported Oct 14, 2026 · Z-0113-2027

Product may be potentially contaminated with a lubricant used during the manufacturing process.

Reported Oct 14, 2026 · Z-0099-2027

QUANTUM OPS Inc · Chattanooga, TN

Due to a manufacturing issue (inadequate weld) for patient head positioning system.

Reported Oct 14, 2026 · Z-0076-2027

A navigation system used to aid in selection and positioning of orthopedic implant system components has a workstation that may contain a 15-inch MacBook Pro battery, subject to an Apple battery recall, that may overheat and pose a fire safety risk.

Reported Oct 14, 2026 · Z-0119-2027

Potential for false negative patient results.

Reported Oct 14, 2026 · Z-0082-2027

Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions

Reported Oct 14, 2026 · Z-0116-2027

Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing.

Reported Oct 14, 2026 · Z-0117-2027

Product may be potentially contaminated with a lubricant used during the manufacturing process.

Reported Oct 14, 2026 · Z-0097-2027

Product may be potentially contaminated with a lubricant used during the manufacturing process.

Reported Oct 14, 2026 · Z-0102-2027

Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions

Reported Oct 14, 2026 · Z-0114-2027

Product may be potentially contaminated with a lubricant used during the manufacturing process.

Reported Oct 14, 2026 · Z-0100-2027

TODD'S SEEDS LLC · Cookeville, TN

Products contain alfalfa seed recalled by the supplier and may be contaminated with E. coli and/or Salmonella (downstream recall)

Reported Oct 7, 2026 · H-1407-2026

Product contains elevated levels of lead.

Reported Oct 7, 2026 · H-1402-2026

LMSI, LLC · Montgomery, OH

Product contains garlic essential oil not approved for culinary use

Reported Oct 7, 2026 · H-1399-2026