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 3, 2026. New recalls appear here on the FDA's own publishing schedule.

59,102 recall(s)

Open, ClassifiedPosted Jun 23, 2026·Initiated May 20, 2026

Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241

Reason: Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

Root cause: Under Investigation by firm

Recalling firm: Zimmer, Inc.Type: Shoulder Prosthesis, Reverse ConfigurationDistribution: US Nationwide distribution.Recall #Z-2528-2026

Open, ClassifiedPosted Jun 23, 2026·Initiated May 20, 2026

Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040242

Reason: Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

Root cause: Under Investigation by firm

Recalling firm: Zimmer, Inc.Type: Shoulder Prosthesis, Reverse ConfigurationDistribution: US Nationwide distribution.Recall #Z-2529-2026

Open, ClassifiedPosted Jun 23, 2026·Initiated May 20, 2026

Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040444

Reason: Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

Root cause: Under Investigation by firm

Recalling firm: Zimmer, Inc.Type: Shoulder Prosthesis, Reverse ConfigurationDistribution: US Nationwide distribution.Recall #Z-2530-2026

Open, ClassifiedPosted Jun 23, 2026·Initiated May 20, 2026

Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040476

Reason: Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

Root cause: Under Investigation by firm

Recalling firm: Zimmer, Inc.Type: Shoulder Prosthesis, Reverse ConfigurationDistribution: US Nationwide distribution.Recall #Z-2531-2026

Open, ClassifiedPosted Jun 23, 2026·Initiated May 28, 2026

Acumed Hexalob Screw various sizes: REF Numbers: : 3070-27008 2.7mm x 8mm NL Hexalobe Screw; 3070-27009 2.7mm x 9mm NL Hexalobe Screw; 3070-27010 2.7mm x 10mm NL Hexalobe Screw; 3070-27011 2.7mm x 11mm NL Hexalobe Screw; 3070-27012 2.7mm x 12mm NL Hexalobe Screw; 3070-27013 2.7mm x 13mm NL Hexalobe Screw; 3070-27014 2.7mm x 14mm NL Hexalobe Screw; 3070-27015 2.7mm x 15mm NL Hexalobe Screw; 3070-27016 2.7mm x 16mm NL Hexalobe Screw; 3070-27017 2.7mm x 17mm NL Hexalobe Screw; 3070-27018 2.7mm x 18mm NL Hexalobe Screw; 3076-30010 3.0mm x 10mm NL Hexalobe Screw; 3076-30012 3.0mm x 12mm NL Hexalobe Screw; 3076-30014 3.0mm x 14mm NL Hexalobe Screw

Reason: Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use.

Root cause: Device Design

Recalling firm: Acumed LLCType: Plate, Fixation, BoneDistribution: US Nationwide distribution in the states of AR, CA, CO, CT, FL, GA, IL, KS, KY, LA, MA, MS, NC, NM, NY, OH, OK, OR, PA, SC, TN, TX, UT, WA, WI.Recall #Z-2532-2026

Open, ClassifiedPosted Jun 22, 2026·Initiated Apr 22, 2026

Da Vinci ASSY, PSS, SP1098, Part Number: 380601

Reason: Operative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a structural column failure, the E-brake pin would prevent E-brake engagement and may result in uncontrolled motion. In addition, if it moves/backs out it may cause restricted column range of motion and/or uncontrolled motion, which may cause patient tissue injury/crushing injury/bleeding.

Root cause: Process control

Recalling firm: Intuitive Surgical, Inc.Type: System, Surgical, Computer Controlled InstrumentDistribution: Worldwide - US Nationwide distribution including in the states of CA, GA, OH, PA, NY, MN, TN, OR, IL, MD, NJ, AL, NV, TX, FL, LA, CT, NC, AZ, IA, MO, WA, MI, WV, WI, KY, KS, VA, OK, MA, IN, CO, SC, SD, MS, NH, UT, ME and the countries of Belgium, Denmark, Sweden, France, Japan, Germany, Israel, Switzerland, South Korea, Czech Republic, Austria, United Kingdom, Italy, Spain, Ireland, Saudi Arabia, Greece, Taiwan, Australia, China, Turkey, Poland, United Arab Emirates, Hong Kong, Romania.Recall #Z-2521-2026

Open, ClassifiedPosted Jun 22, 2026·Initiated May 26, 2026

Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A

Reason: Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output.

Root cause: Process control

Recalling firm: Philips North America LlcType: System, Monitoring, PerinatalDistribution: Worldwide distribution - US Nationwide and The countries of AE, AT, AU, BE, BG, BH, BR, CA, CH, CN, CR, CZ, DE, ES, FI, FR, GB, GR, HK, ID, IL, IN, IT, JO, JP, KR, KR, LT, LU, LV, MX, MY, NL, NZ, OM, SA, SE, SG, SI, TR, TW, ZA.Recall #Z-2522-2026

Open, ClassifiedPosted Jun 22, 2026·Initiated May 26, 2026

Philips Avalon Fetal Monitor, FM 30 Part numberM2703A

Root cause: Process control

Open, ClassifiedPosted Jun 22, 2026·Initiated Feb 11, 2026

TMJ Bilateral Implants, REF: CHG020

Reason: Custom temporomandibular joint implant may have contained incorrect patient-specific components that led to a poor fit of the implant, leading to a right-sided open bite.

Root cause: Process control

Recalling firm: TMJ Solutions IncType: Joint, Temporomandibular, ImplantDistribution: US Nationwide distribution in the state of MA.Recall #Z-2524-2026

Open, ClassifiedPosted Jun 18, 2026·Initiated May 8, 2026

Giraffe Stand-alone Infant Resuscitation System; Powered emergency ventilator (resuscitator) Product identifiers: 2082663-001, 2082663-002, M1241424 Product impacted only if service blender M1091607-R was installed during the last Preventative Maintenance

Reason: Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in hypoxia or hyperoxia in the patient.

Root cause: Process control

Recalling firm: Datex-Ohmeda IncType: Ventilator, Emergency, Manual (Resuscitator)Distribution: PendingRecall #Z-2357-2026

Open, ClassifiedPosted Jun 18, 2026·Initiated May 8, 2026

Giraffe Warmer with Integrated Resuscitation System (iRes), Panda Warmer with Integrated Resuscitation System (iRes) Product Identifiers: M1118179, M1112198 Impacted only if service blender M1091607-R was installed during the last Preventative Maintenance.

Root cause: Process control

Recalling firm: Datex-Ohmeda IncType: Warmer, Infant RadiantDistribution: PendingRecall #Z-2358-2026

Open, ClassifiedPosted Jun 18, 2026·Initiated May 8, 2026

Panda Freestanding Warmer, Infant Radiant Warmer Product Identifiers: 2063568-001 Impacted only if service blender M1091607-R was installed during the last Preventative Maintenance.

Root cause: Process control

Recalling firm: Datex-Ohmeda IncType: Warmer, Infant RadiantDistribution: PendingRecall #Z-2359-2026

Open, ClassifiedPosted Jun 18, 2026·Initiated May 18, 2026

Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.

Reason: Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support.

Root cause: Under Investigation by firm

Recalling firm: Abiomed, Inc.Type: Temporary Non-Roller Type Left Heart Support Blood PumpDistribution: US distribution to GA, IA, NE, PA, TX, WA, WI. International distribution to Czech Republic, Norway, and JapanRecall #Z-2457-2026

Open, ClassifiedPosted Jun 18, 2026·Initiated Apr 20, 2026

Product Name: STAAR ICL Calculation Software Software Version: Version 8.00 Product Description: The STAAR ICL Calculation Software is designed as an aide in the calculation of the size and diopter power (with residual refraction) for physician selection of the lens. For toric ICLs, an Implantation Orientation Diagram (IOD) is also produced to provide the physician with pictorial representation of the axis of rotation and alignment. Note: The STAAR ICL Calculation Software resides on STAAR Surgical's e-commerce website in STAAR ICL planning support (Stella), as referenced in the attached recall communication. Component: No

Reason: Due to a software coding issues for calculating the implant orientation diagram printout for the implantation for toric implantable collamer lenses.

Root cause: Software design

Recalling firm: Staar Surgical AGType: Lens, Intraocular, PhakicDistribution: Worldwide - US Nationwide distribution including in the states and territory of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Austria, Australia, Belgium, Canada, Switzerland, Czech Republic, Germany Spain, Finland, France, Great Britain, Hong Kong, Ireland, Israel, India, Iran, Italy, Jordan, Korea, Kuwait, Kazakhstan, Morocco, Malaysia, Netherlands, Oman, Philippines, Poland, Saudi Arabia, Sweden, Singapore, Thailand, Turkey, Taiwan, Ukraine, USA, Vietnam.Recall #Z-2509-2026

Open, ClassifiedPosted Jun 18, 2026·Initiated Sep 23, 2025

iLet Bionic Pancreas, REF: BB1001

Reason: The reason for the recall is: it was found in version 3.3.6 of the iLet ACE Pump firmware and all previous releases that a screen unlock failure could occur when the user successfully slides the unlock slider on the Lock Screen, no screen transition occurs, and the user remains on the Lock Screen. Because the user cannot exit the Lock Screen, the user is unable to perform a cartridge change or meal announcement. If this occurs and therapy is in progress, therapy will continue normally until the insulin cartridge is depleted. The user will be unable to perform a cartridge change or a meal announcement and will be stuck on the screen until the battery fully drains. This can lead to hyperglycemia.

Root cause: Software design

Recalling firm: Beta Bionics, Inc.Type: Alternate Controller Enabled Insulin Infusion PumpDistribution: US: WI, HI, OH, ME, CO, NJ, NE, KY, SC, CA, TX, NH, NY, WA, PA, MD, FL, IA, GA, MI, VT, TN, IL, IN, KS, MA, LA, MS, NC, CT, MN, VA, OK, AR, AZ, MO, MT, RI, DC, NM, OR, ID, NV, AK, ND, DE, WV, WY, SD, UT, ALRecall #Z-2513-2026

Open, ClassifiedPosted Jun 18, 2026·Initiated May 21, 2026

BD Connecta" BD Luer-Lok" 360 REF 394910 UDI-DI code: 00382903949106 BD Connecta" Stopcocks are used to administer fluids or medication through one or two different ports via an IV cannula or extension tube. The ports can be used to sample blood or for hemodynamic monitoring. When used with IV lipid nutritional products, the stopcock device can be used for up to 24 hours.

Reason: Due to stopcock issues when using the plastic luer-lok syringe, the connection at the Port C may over thread or continue to spin rather than tightening securely. This behavior has led some clinical users to perceive the connection as unstable.

Root cause: Device Design

Recalling firm: BD SWITZERLAND SARLType: Stopcock, I.V. SetDistribution: U.S.: AK, AL, AR, AZ, CA, CO, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV. O.U.S.: JapanRecall #Z-2514-2026

Open, ClassifiedPosted Jun 18, 2026·Initiated May 11, 2026

Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire Respiratory Sensing Lead Model/Catalog Number: 4340 Software Version: N/A Product Description: The Inspire Respiratory Sensing Lead (Model 4340) is designed to detect respiratory effort. The lead features a pressure sensitive membrane that converts the mechanical energy of respiration into an electrical signal. The lead incorporates a standard connector for coupling to the implantable pulse generator (IPG). Component: N/A

Reason: Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Material degradation of a product past its Use By Date may result in unplanned or premature revision surgery.

Root cause: Process control

Recalling firm: Inspire Medical Systems Inc.Type: Stimulator, Hypoglossal Nerve, Implanted, ApneaDistribution: Worldwide distribution - US Nationwide and the country of Hong Kong.Recall #Z-2515-2026

Open, ClassifiedPosted Jun 18, 2026·Initiated May 11, 2026

Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation Lead Model/Catalog Number: 4063 Product Description: The Inspire Stimulation Lead (Model 4063) is designed to deliver stimulation to the hypoglossal nerve for the treatment of obstructive sleep apnea. The lead features a flexible, self-sizing cuff. Electrodes in the inner surface of the cuff deliver stimulation to the nerve. The lead incorporates a standard connector for coupling to the implantable pulse generator (IPG). Component: N/A

Root cause: Process control

Recalling firm: Inspire Medical Systems Inc.Type: Stimulator, Hypoglossal Nerve, Implanted, ApneaDistribution: Worldwide distribution - US Nationwide and the country of Hong Kong.Recall #Z-2516-2026

Open, ClassifiedPosted Jun 18, 2026·Initiated May 8, 2026

Splashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-DI codes: 00884450529645 00884450529669 00884450529690 REF: MSWSTDA35180 UDI-DI codes: 00884450529645 00884450529669 REF: MSWSTDA35260EX UDI-DI code: 00884450529683 REF: MSWSTDA3580 UDI-DI codes: 00884450529645 00884450529690 00884450529744 REF: MSWSTDS35150 UDI-DI codes: 00884450529690 00884450529744 REF: MSWSTFA35260EX UDI-DI code: 00884450529447 REF: MSWSTFA3580 UDI-DI code: 00884450529515 REF: MSWSTFS35150 UDI-DI code: 00884450529553 The Merit Hydrophilic Guide Wire is intended to be used in the peripheral vascular system to facilitate the placement of devices during diagnostic and interventional procedures.

Reason: Due to unsealed portions of pouches.

Root cause: Process design

Recalling firm: Merit Medical Systems, Inc.Type: Wire, Guide, CatheterDistribution: Worldwide - U.S. Nationwide distribution in the states and territory AL, AZ, CA, FL, GA, IA, ID, IL, IN, KS, MA, MD, ME, MI, MN, MO, MS, NC, NH, NJ, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, and Puerto Rico. The countries of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Guatemala, Ireland, Italy, Kazakhstan, Kenya, Netherlands, Norway, Portugal, Spain, Sweden, and Switzerland.Recall #Z-2517-2026

Open, ClassifiedPosted Jun 18, 2026·Initiated May 13, 2026

Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist System (LVAS) is a set of equipment and materials that together comprise a medical device designed to provide therapeutic benefit to those affected with advanced heart failure. In service, the LVAS assumes some or all of the workload of the left ventricle, thereby restoring the patient's systemic perfusion while palliating the underlying pathology. The LVAS features a Left Ventricular Assist Device (LVAD), a blood pump intended for long-term implantation in such patients, an extracorporeal Controller, plus all of the features, controls, attachments, interfaces, power sources, supporting equipment, labeling, and tools required to achieve the desired therapeutic benefit. Component: No

Reason: Due to 11 volt Backup Battery failures.

Root cause: Under Investigation by firm

Recalling firm: Thoratec LLCType: Ventricular (Assist) BypassDistribution: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and the countries of Canada, Germany, Japan, Netherlands, Poland, Spain.Recall #Z-2518-2026