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 27 of 30

Class IIDeviceOngoing
Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
AVID Medical, Inc. · Toano, VA

Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.

Class IIDeviceOngoing
CONMED Linvatec GENESYS CrossFT Suture Anchor with Disposable Driver REF# CFBC-5502B 5.5mm GENESYs CrossFT Suture Anchor with two, #2 (5 metric) Hi-Fi Sutures Sterile
ConMed Corporation · Utica, NY
Class IIDeviceOngoing
healthmark ProChek-II, Model Number PT-313, PT-201-12
Healthmark Industries Co., Inc. · Fraser, MI
Class IIDeviceOngoing
Medline convenience kits labeled as: 1) GYN ROBOTIC CDS, Medline Kit SKU CDS982888Q; 2) GYN ROBOTIC ADD ON PACK, Medline Kit SKU DYNJ43837D; 3) OH GYN/LAP ROBOT PACK, Medline Kit SKU DYNJ89759; 4) GYN LAPAROSCOPY PACK, Medline Kit SKU DYNJ89781; 5) ROBOT ME RF, Medline Kit SKU DYNJ900203N; 6) GYN LAPAROSCOPY, Medline Kit SKU DYNJ900541Q; 7) ROBOTIC, Medline Kit SKU DYNJ903485K; 8) ROBOTIC GYN, Medline Kit SKU DYNJ905230K; 9) LAPAROSCOPIC GYN AND COLON, Medline Kit SKU DYNJ906013I; 10) GYN LAPAROSCOPIC PACK, Medline Kit SKU DYNJ909394B; 11) GYN ROBOTIC, Medline Kit SKU DYNJ909526B; 12) GYN ROBOTIC, Medline Kit SKU DYNJ909526C; 13) GYN ONC ROBOTIC, Medline Kit SKU DYNJ910180; 14) GYN ROBOTIC, Medline Kit SKU DYNJ910181; 15) GYN ROBOTIC, Medline Kit SKU DYNJ910181A; 16) ROBOTICS, Medline Kit SKU DYNJ912062.
Class IIDeviceOngoing
Midmark IQecg Digital ECG, Model/Catalog Number: 4-000-0061, 4-000-0062 Software Version: Midmark IQecg Plugin versions starting with v10 and prior to v10.1.0.18.
Midmark Corporation · Versailles, OH
Class IIDeviceOngoing
Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
AVID Medical, Inc. · Toano, VA
Class IIDeviceOngoing
Medline convenience kits labeled as: 1) OPEN HEART PACK, Medline Kit SKU CDS840393P; 2) OPEN HEART PACK, Medline Kit SKU CDS840393Q; 3) OPEN HEART PROCEDURE, Medline Kit SKU CDS980895W; 4) VALVE CDS, Medline Kit SKU CDS981551G; 5) FEM POP, Medline Kit SKU CDS982028W; 6) PACK,OPEN HEART, Medline Kit SKU DYNJ906903F; 7) PACK,CLOSED HEART, Medline Kit SKU DYNJ906904C; 8) ENDOSCOPIC SKULL BASE, Medline Kit SKU DYNJ908362F; 9) OPEN HEART, Medline Kit SKU DYNJ910947; 10) CV, Medline Kit SKU DYNJ911488.
Class IIDeviceOngoing
Medline medical convenience kits, labeled as: 1) CRANIOTOMY PACK, Medline Kit SKU DYNJT6545; 2) ORTHO SPINE PACK, Medline Kit SKU DYNJ88056A; 3) ENT SINUS PACK, Medline Kit SKU DYNJ89001; 4) THYROID ENT, Medline Kit SKU DYNJ908641.
Class IIDeviceOngoing
Medline medical convenience kits, labeled as: 1) LAMINECTOMY PACK, Medline Kit SKU DYNJT6548; 2) ORTHO SPINE PACK, Medline Kit SKU DYNJ44504G; 3) NEURO SPINE PACK, Medline Kit SKU DYNJ45419F; 4) CRANIOTOMY PACK, Medline Kit SKU DYNJ46024F; 5) SPINE PACK, Medline Kit SKU DYNJ54479C; 6) CRANIOTOMY PACK, Medline Kit SKU DYNJ58006B; 7) ORTHO-LAMINECTOMY PACK, Medline Kit SKU DYNJ58014A; 8) SPINE PACK, Medline Kit SKU DYNJ83585; 9) ORTHO SPINE PACK, Medline Kit SKU DYNJ88056; 10) CRANI MT CARMEL, Medline Kit SKU DYNJ900467I; 11) GP-NEURO SPINE PACK-LF, Medline Kit SKU PHS396933009C.
Class IIDeviceOngoing
American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AN
American Contract Systems Inc · Tiffin, OH
Class IIDeviceOngoing
FUJIFILM Synapse PACS software v7.4.310; radiological image processing system
FUJIFILM Healthcare Americas Corporation · Lexington, MA
Class IIDeviceOngoing
Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.
Philips Healthcare (Suzhou) Co., Ltd. · Suzhou, N/A
Class IIDeviceOngoing
Medline convenience kits labeled as: MAJOR HEAD AND NECK PPS, Medline Kit SKU DYNJ9425991S
Medline Industries, LP · Northfield, IL
Class IIDeviceOngoing
healthmark ProChek-W Protein Test for Robotic Arms; ProChek-Semi Quantitative Protein Test, Model Number PT-SQ-001
Healthmark Industries Co., Inc. · Fraser, MI
Class IIDeviceOngoing
Medline convenience kits labeled as: 1) LAVH, Medline Kit SKU CDS982273U; 2) GYN ABDOMINAL CDS, Medline Kit SKU CDS982654L; 3) GYN LAP HYSTERECTOMY CDS, Medline Kit SKU CDS982662Q; 4) CMH VAG HYSTERECTOMY PK-LF, Medline Kit SKU DYNJ54382F; 5) A P RESECTION, Medline Kit SKU DYNJ903467L.
Class IIDeviceOngoing
Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm, Product Codes: 1) 949-3594, Mfr Product Code 1840; Lots 2529604, 2538147, 2608145 2) 949-3595, Mfr Product Code 1841; Lots 2539075, 2539313, 2609789, 2539065 3) 949-3596, Mfr Product Code 1842; Lots 2536632, 2609174, 2610099 4) 949-3597, Mfr Product Code 1843; Lots 2535296, 2537418, 2607283 is a light-cured, nano-hybrid dental composite restorative material intended for direct restorative procedures.
Class IIDeviceOngoing
American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AM
American Contract Systems Inc · Tiffin, OH
Class IIDeviceOngoing
PORTRAIT CORE SERVICES SOFTWARE V1.1, Ref# 5700209
GE Medical Systems Information Technologies Inc · Waukesha, WI
Class IIDeviceOngoing
American Contract System Convenience Kits, CV B PACK, Model/Catalog Number: TNCB10AP
American Contract Systems Inc · Tiffin, OH
Class IFoodOngoing
Whole Foods Medium Pico de Gallo Guacamole Dip, Keep Refrigerated. Packed in various sized clear plastic containers. Product is weighed and a finished product label is applied. Products contain the following PLU Cods located under label bar code: 29802800000. Packed for Whole Foods Market, located at either 1745 W. Market Street, Akron, OH 44313 or 4301 W. William Cannon, Austin, TX 78749.
Class IIIFoodOngoing
Prospector Popcorn Fudge Brownie Gourmet Popcorn 1.5oz and 3.5oz
Prospector Popcorn, LLC · Ridgefield, CT
Class IFoodTerminated
Organic Whole Mixed Berries, Net Wt. 48 oz (3Lb) plastic bag. packed in 6 bags per case of 10 oz each. Keep Frozen. UPC 41415-12153
Class IFoodOngoing
Whole Foods Spicy Guacamole Dip, Keep Refrigerated. Packed in various sized clear plastic containers. Product is weighed and a finished product label is applied. Products contain the following PLU Cods located under label bar code: 21212000000, 21211900000, 25138200000. Packed for Whole Foods Market, located at either 1745 W. Market Street, Akron, OH 44313 or 4301 W. William Cannon, Austin, TX 78749.
Class IIFoodCompleted
Protein Cereal Cocoa Crunch. Shelf stable, ready to eat cereal product. 25-year shelf life, metalized poly pillow pouch. Net wt.8.9 oz (252g). 1 pillow pouch per kit. Nutrient, 110 Woodland Ave Reno, NV 89523. No UPC Not for individual retail sale
Class IFoodOngoing
Whole Foods Pomegranate Guacamole Dip, Keep Refrigerated. Packed in various sized clear plastic containers. Product is weighed and a finished product label is applied. Products contain the following PLU Cods located under label bar code: 27908100000, 27908500000. Packed for Whole Foods Market, located at either 1745 W. Market Street, Akron, OH 44313 or 4301 W. William Cannon, Austin, TX 78749.
Class IIIFoodOngoing
Prospector Popcorn Maple Walnut Ice Cream Gourmet Popcorn 3.5 oz.
Prospector Popcorn, LLC · Ridgefield, CT
Class IIFoodOngoing
Gifford's HomeMaine ice cream brand POWER PLAY FUDGE; ONE QUART (946 mL); UPC: 8 60864 00030 7
Gifford's Dairy, Inc. · Skowhegan, ME
Class IFoodTerminated
Organic Whole Mixed Berries, Net Wt. 10 oz (284 g) plastic bags, packed in 8 bags per case of 10 oz each. Keep Frozen. UPC 41415-06753
Class IIFoodOngoing
Prospector Popcorn Chocolate Mocha Gourmet Popcorn 1.5 oz.
Prospector Popcorn, LLC · Ridgefield, CT
Class IIIFoodOngoing
Prospector Popcorn Belgian Chocolate Toffee Gourmet Popcorn 3.5oz
Prospector Popcorn, LLC · Ridgefield, CT
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Source: openFDA enforcement reports. Not for medical decisions; data may be incomplete or unvalidated.

Reported Sep 2, 2026 · Z-3008-2026

Suture anchor may contain incorrect patient implant card which may result in incorrect device identification and traceability.

Reported Sep 2, 2026 · Z-3018-2026

Test manufactured with an expired ingredient which may present as either a false negative or positive.

Reported Sep 2, 2026 · Z-3031-2026

Medline Industries, LP · Northfield, IL

Kits contain a potentially contaminated component which were recalled by the manufacturer

Reported Sep 2, 2026 · Z-3025-2026

A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.

Reported Sep 2, 2026 · Z-3012-2026

Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.

Reported Sep 2, 2026 · Z-3007-2026

Medline Industries, LP · Northfield, IL

Kits contain a potentially contaminated component which were recalled by the manufacturer

Reported Sep 2, 2026 · Z-3020-2026

Medline Industries, LP · Northfield, IL

Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification levels of endotoxin of the neurosponges.

Reported Sep 2, 2026 · Z-2995-2026

Medline Industries, LP · Northfield, IL

Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification levels of endotoxin of the neurosponges.

Reported Sep 2, 2026 · Z-2997-2026

The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representative samples did not meet applicable performance specifications.

Reported Sep 2, 2026 · Z-3001-2026

Software issue may cause the ruler measurement to be inaccurate.

Reported Sep 2, 2026 · Z-3030-2026

Potential of failing to trigger clinical scan during Bolus Tracking.

Reported Sep 2, 2026 · Z-2988-2026

Kits contain a potentially contaminated component which were recalled by the manufacturer

Reported Sep 2, 2026 · Z-3021-2026

Test manufactured with an expired ingredient which may present as either a false negative or positive.

Reported Sep 2, 2026 · Z-3032-2026

Medline Industries, LP · Northfield, IL

Kits contain a potentially contaminated component which were recalled by the manufacturer

Reported Sep 2, 2026 · Z-3027-2026

Henry Schein Inc. · Denver, PA

Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device.

Reported Sep 2, 2026 · Z-3016-2026

The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representative samples did not meet applicable performance specifications.

Reported Sep 2, 2026 · Z-3000-2026

Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings previously configured for each patient or care area.

Reported Sep 2, 2026 · Z-3036-2026

The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representative samples did not meet applicable performance specifications.

Reported Sep 2, 2026 · Z-3002-2026

WFM Purchasing, LP · Austin, TX

Salsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.

Reported Aug 26, 2026 · H-1249-2026

Inaccurately declared nutrients including Potassium (overstated) and Calcium (overstated).

Reported Aug 26, 2026 · H-1234-2026

Publix Super Markets, Inc. · Lakeland, FL

Due to potential E. coli O145:H28 contamination

Reported Aug 26, 2026 · H-1241-2026

WFM Purchasing, LP · Austin, TX

Salsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.

Reported Aug 26, 2026 · H-1252-2026

Nutrient Foods, LLC · Reno, NV

Soy not declared in the contains statement.

Reported Aug 26, 2026 · H-1231-2026

WFM Purchasing, LP · Austin, TX

Salsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.

Reported Aug 26, 2026 · H-1250-2026

Inaccurately declared nutrients including Potassium (overstated), Calcium (overstated), and Iron (understated).

Reported Aug 26, 2026 · H-1233-2026

Potential foreign object contamination: rubber pieces

Reported Aug 26, 2026 · H-1245-2026

Publix Super Markets, Inc. · Lakeland, FL

Due to potential E. coli O145:H28 contamination

Reported Aug 26, 2026 · H-1240-2026

Inaccurately declared nutrients including Carbohydrates (understated) and Cholesterol (understated).

Reported Aug 26, 2026 · H-1232-2026

Inaccurately declared nutrients including Iron (understated), and Vitamin D (overstated).

Reported Aug 26, 2026 · H-1235-2026