FDA Updates

Every medical device recall the FDA publishes, pulled live from openFDA's Device Recall database - the same records behind the FDA's own recall pages. No manual sync: this page re-fetches on its own, so a recall shows up here as soon as the FDA posts it. Not filtered to devices in our catalog.

openFDA last refreshed this dataset on September 10, 2026. New recalls appear here on the FDA's own publishing schedule.

59,131 recall(s)

Open, ClassifiedPosted Mar 24, 2025·Initiated Feb 12, 2025

Z1 Femoral Hip System, Product Number 611777612

Reason: There is a potential design issue with the Z1 Offset Stem Inserter leading to fracturing of the distal tip.

Root cause: Under Investigation by firm

Recalling firm: Zimmer, Inc.Type: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedDistribution: US Nationwide distribution.Recall #Z-1329-2025

Open, ClassifiedPosted Mar 24, 2025·Initiated Feb 27, 2025

NexGen LPS Flex, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis, Model Number 00-5962-042-10

Reason: The "Use with plate 7, 8, 9, 10" compatibility statement on top of the label does not match with the compatibility statements "USE WITH PLATE 5, 6" in the translations section of the same label.

Root cause: Labeling Change Control

Recalling firm: Zimmer, Inc.Type: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerDistribution: Worldwide - US Nationwide distribution in the states pf CA, KS, MA, MD, ME, NE, NJ, OR, SD, and TX. The countries of Canada, China, India, Netherlands, Singapore.Recall #Z-1433-2025

Open, ClassifiedPosted Mar 24, 2025·Initiated Jan 27, 2025

Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D

Reason: Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect dilator use may result in procedure delay.

Root cause: Packaging process control

Recalling firm: Merit Medical Systems, Inc.Type: Introducer, CatheterDistribution: International distribution to the country of Japan.Recall #Z-1434-2025

Open, ClassifiedPosted Mar 21, 2025·Initiated Feb 19, 2025

CVAC Aspiration System, REF: CVC127020-1, and User Manual L00018. Intended for endoscopic examination/treatment of urinary tract and kidney interior.

Reason: Aspiration system, for endoscopic examination/treatment of urinary tract and kidney interior, to have labeling update adding additional instructions, for patients with high viscosity fluid in the kidney, not to continue providing fluid inflow in the presence of unresolved slow or absent fluid outflow because this can create intrarenal pressure imbalance, and lead to excessive intrarenal pressure.

Root cause: Device Design

Recalling firm: Calyxo, Inc.Type: Endoscopic Access Overtube, Gastroenterology-UrologyDistribution: US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV.Recall #Z-1396-2025

Open, ClassifiedPosted Mar 21, 2025·Initiated Feb 27, 2025

Premier Solo Diamond - Large Invented Cone; SKU: 807016C.

Reason: The hardness not meeting the material specification and may cause the diamond bur to bend.

Root cause: Process control

Recalling firm: Premier Dental Products CoType: Bur, DentalDistribution: US Nationwide distribution in the states of CA, MN, NY, PA, TN, VA, WA.Recall #Z-1408-2025