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 19 of 30

Class IIDeviceOngoing
Workflow Core Services V8, intended to provide set of services for storage and retrieval of patient data, exams and performs system Administration, common configuration management for consuming applications, All versions
GE Healthcare · Chicago, IL
Class IIDeviceOngoing
REF:B11LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 11X100MM
Stryker Sustainability Solutions · Tempe, AZ
Class IIDeviceOngoing
Philips Patient Information Center iX REF:866389
Philips North America · Cambridge, MA
Class IIDeviceOngoing
Enterprise Archive V8, software product for receiving, archiving, and sending electronic medical data, All versions
GE Healthcare · Chicago, IL
Class IDeviceOngoing
StatStrip Glucose Hospital Meter System. Model No: 66739. Glucose test system.
Nova Biomedical Corporation · Waltham, MA
Class IIDeviceOngoing
Convenience kits MINOR PACK DYNJ58421A SPRINGHILL MINOR PACK DYNJ40734F
Medline Industries, LP · Northfield, IL
Class IIDeviceOngoing
TRIATHLON HINGE INSERT SIZE 4 11MM 5612-P-411 TRIATHLON HINGE INSERT SIZE 4 13MM 5612-P-413 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
Howmedica Osteonics Corp. · Mahwah, NJ
Class IDeviceOngoing
Medline Convenience Kits: 1) PORT ACCESS KIT UNIV OF ALA, Catalog Number: DYKM1414; 2) ARTERIAL LINE ST JOES SYR PACK, Catalog Number: DYNJ38145F
Class IDeviceOngoing
Haylard CONTINUOUS NERVE BLOCK TRAY; Model/Item Number (Kit): BMCN001-05;
AVID Medical, Inc. · Toano, VA
Class IIDeviceOngoing
Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006
restor3d Inc. · Durham, NC
Class IIDeviceOngoing
Aisys, Datex-Ohmeda anesthesia system, Part Number 1011-9050-000
Datex-Ohmeda, Inc. · Madison, WI
Class IIDeviceOngoing
AXLE PIN ASSY LARGE ELBOW COBALT CHROME Catalog No. C-M112-2-500 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
Howmedica Osteonics Corp. · Mahwah, NJ
Class IIDeviceOngoing
EWO_02513 (Catalog number 320122) For Investigational Use Only Nano Un-Cannulated Demo Samples Quantity 100
embecta Medical II LLC · Parsippany, NJ
Class IIDeviceOngoing
CADD Yellow Medication Cassette Reservoir with NRFit connector US Product Codes: 21-7600-24, 21-7609-24 OUS Product Codes: 21-7609-24 21-7600-24 21-7600-24 21-7600-24 21-7609-24 21-7609-24 21-7600-24 21-7600-24 21-7609-24 21-7609-24 21-7600-24 21-7600-24 21-7609-24 21-7600-24 21-7600-24 21-7609-24 21-7609-24JP 21-7600-24JP 21-7609-24 21-7609-24 21-7600-24 21-7600-24 21-7609-24 21-7600-24 21-7600-24 21-7600-24 21-7609-24
Class IIDeviceOngoing
REF:2B5LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 100MM
Stryker Sustainability Solutions · Tempe, AZ
Class IIDeviceOngoing
Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number: SG-0002 Software Version: 6.0.2, 6.0.4, 6.0.5, 6.0.6 Product Description: The DASH¿ Rapid PCR Instrument (DASH Instrument) is an automated, fluorescence-based, reverse-transcription polymerase chain reaction (RT-PCR) instrument that extracts specimens and performs nucleic acid amplified tests (NAAT) in DASH test cartridges for the qualitative detection of infectious diseases. The DASH Instrument is intended for use in conjunction with DASH Rapid PCR System tests to aid in the diagnosis of infectious diseases. Component: No.
Class IIDeviceOngoing
Blood Culture Collection Venipuncture Kit 20/Cs, REF: 77451; Blood Culture Kit 20/Cs, REF: 81834B; Blood Culture Collection Kit, REF: 81834C. All containing BD ChloraPrep Clear - 1 mL Applicators
Class IIDeviceOngoing
Percutaneous Insertion Kit (PIK), dilator set L, Model Numbers: 701054427 (USA), 701054427 (OUS);
Maquet Cardiopulmonary Gmbh · Rastatt, N/A
Class IDeviceOngoing
DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625150; DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625200; DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625240; DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625300; DuoGlide Short-Term Curved Extension Dialysis Catheter, REF: 5626120; DuoGlide Short-Term Curved Extension Dialysis Catheter, REF: 5626150; DuoGlide Short-Term Curved Extension Dialysis Catheter, REF: 5626200; DuoGlide Short-Term Curved Extension Dialysis Catheter, REF: 5626240; Niagara Dual-Lumen Short-Term Curved Extension Dialysis Catheter, REF: 5766200
Class IIDeviceOngoing
Convenience kits CATARACT PACK DYNJ59881A
Medline Industries, LP · Northfield, IL
Class IFoodOngoing
Crown Farms Dried Suri Cut, 200 gm, in plastic pack, 25 packages per box, keep frozen
EURO FOODS GROUP USA NJ INC · Totowa, NJ
Class IIFoodOngoing
Prolon Everyday Apulian Almond & Cocoa Spread, NET WT: 8.47 OZ. Product packaged in glass jar with white label and gold screw on closure. UPC: 50040360530
L-Nutra Inc · Los Angeles, CA
Class IFoodOngoing
Momchipz Gluten Free Veggie Chips Broccoli Florets & Cauliflower, net wt. 3oz (85g). UPC 6 28634 44216 6. Ingredients: Broccoli, Cauliflower, Tapioca Flour, Coconut Oil, Salt, White Pepper. Proudly Made in Indonesia. Imported for Exotique Foods, Inc. Toronto, ON - Canada.
Class IFoodOngoing
Alfalfa, Net Weight 50 lbs. bag, Product of USA, International Specialty Supply 1011 Volunteer Dr. Cookeville, TN 38506
International Sprout Holdings, Inc · Cookeville, TN
Class IIFoodOngoing
Fannie May & XO Marshmallow Pixie S'mores Collection, 4.47oz
Ferrero USA · North Canton, OH
Class IIDrugOngoing
fentaNYL Citrate, 1,000 mcg/100 mL (10mcg/mL) Injection solution in 100 mL, 0.9% NaCl Bag, OurPharma LLC, 2512 S. City Lake, Fayetteville, AR, NDC 73013-1013-01.
OurPharma LLC · Fayetteville, AR
Class IIIDrugOngoing
Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution, 10 mL per dropper bottle, For Office Use Only, Imprimis NJOF, LLC, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-732-10
Class IDrugOngoing
Epinephrine Injection, USP, 30 mg/30 mL (1mg/mL), 30 mL-Multiple-Dose Vial, Rx Only, For Intravenous Infusion, intramuscular and Subcutaneous Use, AMERICAN REGENT INC., SHIRLEY, NY 11967. NDC 0517-3030-01
Class IIIDrugOngoing
Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-255-01.
Ajanta Pharma USA Inc · Bridgewater, NJ
Class IDrugOngoing
Dextrose Injection, USP, 70 %, 2000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL, 60016, Made in USA, NDC 00338-0719-06
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Source: openFDA enforcement reports. Not for medical decisions; data may be incomplete or unvalidated.

Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead to misdiagnosis or a delay in patient care.

Reported Sep 23, 2026 · Z-3170-2026

Reusable access port system may crack or seperate during use.

Reported Sep 23, 2026 · Z-3184-2026

Due to software malfunction, patient information system may freeze and become unresponsive.

Reported Sep 23, 2026 · Z-3141-2026

Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead to misdiagnosis or a delay in patient care.

Reported Sep 23, 2026 · Z-3167-2026

A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode including patient identification (ID) barcodes and quality control (QC) solution ID barcodes when a new barcode is scanned, resulting in the prior barcode information remaining displayed on the screen for the current test. When this defect occurs and the operator accepts the incorrectly displayed patient information without recognizing the mismatch, the current patient's glucose result will be incorrectly assigned to the previous patient's medical record and transmitted to the data management system (DMS), and the current patient's medical record will not receive a result, leaving their glucose status unrecorded and their clinical management without the information needed to guide treatment decisions. The previous patient, whose medical record now contains a glucose result that does not belong to them, may receive inappropriate clinical intervention based on that erroneous result, particularly in critically ill patients, neonates, and infants who cannot communicate symptoms or self-treat. The defect also affects QC barcode scanning: if a QC scan triggers the same retention behavior, QC results may be attributed to an incorrect identifier or QC tests may fail without the user recognizing the underlying cause. This defect does not affect the analytical accuracy of glucose measurements.

Reported Sep 23, 2026 · Z-3129-2026

Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field or patient infection if product is used.

Reported Sep 23, 2026 · Z-3208-2026

Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.

Reported Sep 23, 2026 · Z-3198-2026

Medline Industries, LP · Northfield, IL

The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.

Reported Sep 23, 2026 · Z-3123-2026

Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.

Reported Sep 23, 2026 · Z-3152-2026

Ankle implantation systems were packaged with incorrect patient-specific cutting guides, which may result in: delayed surgery, the need to use standard instrumentation, reduced fixation or poor alignment of implants, implant loosening/migration, or need for revision surgery.

Reported Sep 23, 2026 · Z-3178-2026

Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control, the system delivers 100% O2 to the breathing system enabling continued controlled or manual ventilation and initiates audible and visual alarms. When this issue occurs, anesthetic agent delivery will be interrupted and requires clinician intervention. If this is not provided, the patient may experience decreased anesthetic agent effect.

Reported Sep 23, 2026 · Z-3189-2026

Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.

Reported Sep 23, 2026 · Z-3195-2026

Retrospectively reported: Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices.

Reported Sep 23, 2026 · Z-3180-2026

ICU Medical, Inc. · Lake Forest, IL

Reservoirs may exhibit medication leakage at the joint between luer connector and tubing. Issue could result in delay or interruption of therapy, under delivery of medication, exposure to infectious or toxic agents, or air embolus.

Reported Sep 23, 2026 · Z-3212-2026

Reusable access port system may crack or seperate during use.

Reported Sep 23, 2026 · Z-3182-2026

Nuclein LLC · Austin, TX

Due to a software issue

Reported Sep 23, 2026 · Z-3164-2026

Medical Action Industries, Inc. 306 · Arden, NC

Blood culture convenience kits contain a component subject to a drug recall that due to an an open or incomplete seal on the packaging of the applicator may compromise the component's sterile barrier and if used may lead to localized skin or soft tissue infection.

Reported Sep 23, 2026 · Z-3181-2026

The packaging may not consistently maintain sterile barrier integrity.

Reported Sep 23, 2026 · Z-3146-2026

Bard Access Systems, Inc. · Salt Lake City, UT

this is a downstream recall of class I recall RES 98777

Reported Sep 23, 2026 · Z-2985-2026

Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field or patient infection if product is used.

Reported Sep 23, 2026 · Z-3210-2026

The firm imported and distributed dried ribbon fish that was not properly eviscerated prior to drying.

Reported Sep 16, 2026 · H-1331-2026

Undeclared allergen (tree nuts): hazelnut, cashew, and pistachio.

Reported Sep 16, 2026 · H-1335-2026

EXOTIQUE FOODS CANADA · Etobicoke

Undeclared Wheat.

Reported Sep 16, 2026 · H-1330-2026

Potential E. coli and Salmonella contamination

Reported Sep 16, 2026 · H-1341-2026

Undeclared milk and pecans

Reported Sep 16, 2026 · H-1334-2026

Labeling: Not Elsewhere Classified: Complaint received on 08/31/2026 regarding the discrepancy of the IV bag expiry (07/31/2026 and 11/30/2026) and the product expiry (12/09/2026).

Reported Sep 16, 2026 · D-0864-2026

ImprimisRx NJ LLC · Ledgewood, NJ

Subpotent Drug

Reported Sep 16, 2026 · D-0835-2026

American Regent, Inc. · Shirley, NY

Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broken and leaking vials.

Reported Sep 16, 2026 · D-0865-2026

Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the 18 months long term stability. Result: 1.1 percent. Spec: 1.0 percent.

Reported Sep 16, 2026 · D-0836-2026

Baxter Healthcare Corporation · Deerfield, IL

Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.

Reported Sep 16, 2026 · D-0850-2026