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 5, 2026. New recalls appear here on the FDA's own publishing schedule.

59,129 recall(s)

Open, ClassifiedPosted Mar 24, 2026·Initiated Sep 5, 2025

Philips S4-1 Ultrasound Transducer

Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Root cause: Device Design

Recalling firm: Philips Ultrasound, IncType: Transducer, Ultrasonic, DiagnosticDistribution: US Nationwide distribution.Recall #Z-1625-2026

Open, ClassifiedPosted Mar 24, 2026·Initiated Sep 5, 2025

Philips S5-2 Ultrasound Transducer

Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Root cause: Device Design

Recalling firm: Philips Ultrasound, IncType: Transducer, Ultrasonic, DiagnosticDistribution: US Nationwide distribution.Recall #Z-1626-2026

Open, ClassifiedPosted Mar 24, 2026·Initiated Sep 5, 2025

Philips X3-1 Ultrasound Transducer

Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Root cause: Device Design

Recalling firm: Philips Ultrasound, IncType: Transducer, Ultrasonic, DiagnosticDistribution: US Nationwide distribution.Recall #Z-1627-2026

Open, ClassifiedPosted Mar 24, 2026·Initiated Sep 5, 2025

Philips X7-2 Ultrasound Transducer

Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Root cause: Device Design

Recalling firm: Philips Ultrasound, IncType: Transducer, Ultrasonic, DiagnosticDistribution: US Nationwide distribution.Recall #Z-1628-2026

Open, ClassifiedPosted Mar 24, 2026·Initiated Feb 10, 2026

Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component Lantern Knee System

Reason: Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)

Root cause: Nonconforming Material/Component

Recalling firm: Orthalign, IncType: Orthopedic Stereotaxic InstrumentDistribution: US Nationwide distribution in the state of UT.Recall #Z-1629-2026

Open, ClassifiedPosted Mar 24, 2026·Initiated Feb 10, 2026

Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 REF:402567 component Lantern Knee System

Reason: Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)

Root cause: Nonconforming Material/Component

Recalling firm: Orthalign, IncType: Orthopedic Stereotaxic InstrumentDistribution: US Nationwide distribution in the state of UT.Recall #Z-1630-2026

Open, ClassifiedPosted Mar 24, 2026·Initiated Mar 4, 2026

Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe Model/Catalog Number: ES-100V3 (device); BT2M20S8C (2 MHz fetal probe). Software Version: N/A Product Description: Hand-held, battery-powered ultrasonic Doppler blood-flow detector with LCD numeric display, used with interchangeable probes to detect vascular blood-flow signals and display heart rate; affected units were packaged with a 2 MHz BT2M20S8C fetal probe and labeled for both vascular and fetal applications.

Reason: Product labeling includes a fetal indication for use that is not cleared under its 510(k).

Root cause: Labeling Change Control

Recalling firm: Koven Technology, Inc.Type: Flowmeter, Blood, CardiovascularDistribution: US Nationwide distribution in the states of LA, NC, MT, TX MA, OR, NY, IL, CO, GA, FL, WA, WI, MO, AZ, IN.Recall #Z-1631-2026

Open, ClassifiedPosted Mar 24, 2026·Initiated Mar 17, 2026

Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;

Reason: A material mix-up had occurred during the manufacturing of Straumann Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot 7130439) was incorrectly identified as a Titanium Bar Ti Gr4 D (SAP #701922 / Lot 7130430). As a result, RC Titanium abutments were manufactured using the TAN Bar material on Mill-from-Bar Machine 396-06.

Root cause: Process control

Recalling firm: Straumann USA LLCType: Abutment, Implant, Dental, EndosseousDistribution: Worldwide - US Nationwide distribution in the states of CA, CO, FL, IA, IL, MN, MO, MT, OR, WA; and the country of Canada.Recall #Z-1632-2026

Open, ClassifiedPosted Mar 24, 2026·Initiated Mar 17, 2026

Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438;

Root cause: Process control

Open, ClassifiedPosted Mar 24, 2026·Initiated Feb 19, 2026

Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Product Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Model/Catalog Number: DIB00 Software Version: N/A Product Description: The TECNIS SIMPLICITY" Delivery System is designed to provide a sterile,controlled and touch-free method of delivering the lens into the eye. The lens is preloaded and pre-assembled in the delivery system. The TECNIS SIMPLICITY" Delivery System Model DIB00 contains the TECNISEyhance" IOL, which is a one-piece, foldable, posterior chamber lens with an overall diameter of 13.0 mm and an optic diameter of 6.0 mm. The TECNIS SIMPLICITY" Delivery System is designed to provide a sterile,controlled and touch-free method of delivering the lens into the eye. Component: No

Reason: Due to identifying a limited quantity of intraocular lenses that may have a haptic that sticks to the optic which prevents the lens from unfolding as consistently as expected.

Root cause: Process control

Recalling firm: AMO Puerto Rico Manufacturing, Inc.Type: Intraocular LensDistribution: U.S Nationwide distribution in the states of CA,FL, IL, ME,MS, NJ, NY, OK, OR, TX, and WI.Recall #Z-1634-2026

Open, ClassifiedPosted Mar 24, 2026·Initiated Jan 30, 2026

MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61

Reason: Three software defects (Pump Error 53, BG check, and Critical Pump Error (Open Book Image)) that occurred as a result of software updates (versions 6.60, 6.61, and 6.62), which could result in a risk of hypoglycemia or hyperglycemia due to inaccuracies in insulin delivery (either under-delivery, over-delivery, or cessation of delivery).

Root cause: Software change control

Recalling firm: Medtronic MiniMed, Inc.Type: Alternate Controller Enabled Insulin Infusion PumpDistribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH,NJ, NM, NV, NY, OH,OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the country of Israel.Recall #Z-1635-2026

Open, ClassifiedPosted Mar 21, 2026·Initiated Feb 18, 2026

Handy Solutions Neck & Shoulders Heating Pad, Number: 25607, Manufactured by Ninbo Unico Products Co., Ltd

Reason: If heating pad is folded while in use, the power density increases in the folded area causing excessive temperatures, which can also be caused by placing pad under the body, then the high limit device is unable to sense the higher temperature so power is not terminated. May cause a burning smell prior to melting/burning potentially causing burns to persons and property.

Root cause: Device Design

Recalling firm: Navajo Manufacturing CompanyType: Pad, Heating, PoweredDistribution: US Nationwide distribution in the states of CA, MS, FL, IN, LA, VA, TX.Recall #Z-1588-2026

Open, ClassifiedPosted Mar 20, 2026·Initiated Feb 12, 2026

Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILE EO. For surgical use

Reason: Probes may rupture/burst during activation

Root cause: Process control

Recalling firm: Erbe USA IncType: Unit, Cryosurgical, AccessoriesDistribution: US Nationwide distribution, including Puerto Rico.Recall #Z-1566-2026

Open, ClassifiedPosted Mar 20, 2026·Initiated Feb 12, 2026

Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical use

Reason: Probes may rupture/burst during activation

Root cause: Process control

Recalling firm: Erbe USA IncType: Unit, Cryosurgical, AccessoriesDistribution: US Nationwide distribution, including Puerto Rico.Recall #Z-1567-2026

Open, ClassifiedPosted Mar 20, 2026·Initiated Feb 12, 2026

Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use

Reason: Probes may rupture/burst during activation

Root cause: Process control

Recalling firm: Erbe USA IncType: Unit, Cryosurgical, AccessoriesDistribution: US Nationwide distribution, including Puerto Rico.Recall #Z-1568-2026

Open, ClassifiedPosted Mar 20, 2026·Initiated Feb 3, 2026

Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E85101LP

Reason: There is a potential issue that can lead to discordance between the simulated needle trajectory/tip position and the actual needle trajectory/tip position.

Root cause: Device Design

Recalling firm: GE Medical Systems, LLCType: System, X-Ray, Tomography, ComputedDistribution: Worldwide distribution - US Nationwide.Recall #Z-1590-2026

Open, ClassifiedPosted Mar 20, 2026·Initiated Jan 23, 2026

Volar Radius Plate with Angular Stability with the following description: Radius Plate PROlock II. Article Numbers: 21031-3, 21031-5, 21032-11, 21032-3, 21032-5, 21033-3, 21033-5, 21034-3, 21034-5, 21035-3, 21036-3.

Reason: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

Root cause: No Marketing Application

Recalling firm: I.T.S. GmbHType: Plate, Fixation, BoneDistribution: US Nationwide distribution in the states of AL, AZ, BVI, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, OH, OK, PA, SC, TX, USVI, WV, W.Recall #Z-1592-2026

Open, ClassifiedPosted Mar 20, 2026·Initiated Jan 23, 2026

Claviculaplate with Angular Stability, with the below descriptions and associated article numbers. 1. Anterior Clavicle Plate, Medial; Article Numbers: 21116-8, 21117-10, 21118-10. 2. Clavicle Plate; Article Numbers: 21121-6, 21121-8. 3. Clavicle Plate, 3.5mm; Article Numbers: 21122-10, 21122-6, 21122-8. 4. Clavicle Plate, Lateral; Article Numbers: 21123-4, 21124-4, 21127-6, 21128-6.

Reason: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

Root cause: No Marketing Application

Open, ClassifiedPosted Mar 20, 2026·Initiated Jan 23, 2026

Brand Name: Humeral Head Plate with Angular Stability, with the following description: Proximal Humeral Plate. Article Numbers: 211341-10, 211341-4, 211341-7, 21134-4, 21134-5, 21135-4, 21136-4, 21136-5, 21136-7, 21137-4, 21137-7, 21138-4, 21139-4.

Reason: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

Root cause: No Marketing Application

Open, ClassifiedPosted Mar 20, 2026·Initiated Jan 23, 2026

FR.O.H. Calcaneus Repair System with the following description: Anterolateral Calcaneus Plate. Article Number: 21064-60.

Reason: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

Root cause: No Marketing Application