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 30, 2026·Initiated Feb 27, 2026

Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Premium Laser System TFL-PLS Model/Catalog Number: TFL-PLS containing TFL-CPLU Product Description: An electricity powered device assembly which emits a high-power laser beam to vaporize/ablate soft tissue with moderate hemostasis, little charring, and a thin zone of necrosis. Component: No

Reason: Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperable. Additionally, smoke or a burning smell may occur. By design, the issue causing the smoke or burning smell would be contained within the internal laser console enclosure and would be self-extinguishing.

Root cause: Process control

Recalling firm: Olympus Corporation of the AmericasType: Powered Laser Surgical InstrumentDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Chile, Europe, Singapore, Australia, and Hong Kong.Recall #Z-1694-2026

Open, ClassifiedPosted Mar 30, 2026·Initiated Feb 27, 2026

Brand Name: Olympus SOLTIVE Pro SuperPulsed Laser System Product Name: SOLTIVE Pro Laser System TFL-SLS Model/Catalog Number: TFL-SLS containing TFL-CSLU Product Description: An electricity powered device assembly which emits a high-power laser beam to vaporize/ablate soft tissue with moderate hemostasis, little charring, and a thin zone of necrosis. Component: No

Reason: Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperable. Additionally, smoke or a burning smell may occur. By design, the issue causing the smoke or burning smell would be contained within the internal laser console enclosure and would be self-extinguishing.

Root cause: Process control

Recalling firm: Olympus Corporation of the AmericasType: Powered Laser Surgical InstrumentDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Chile, Europe, Singapore, Australia, and Hong Kong.Recall #Z-1695-2026

Open, ClassifiedPosted Mar 30, 2026·Initiated Dec 9, 2025

Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: da Vinci S and Si Monopolar Curved Scissors Instrument Model/Catalog Number: 420179 Software Version: N/A Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories. Please refer to attached User Manual for additional details on intended use. All da Vinci S/Si reusable instruments with jaws use mechanical tungsten cables and pulleys to transmit motion from the input discs to the housing (on the proximal chassis), through the main shaft, and the distal instrument tip (inside the patient). Component: N/A

Reason: Due to increased complaints for broken/frayed grip cables for reusable instruments.

Root cause: Process control

Recalling firm: Intuitive Surgical, Inc.Type: System, Surgical, Computer Controlled InstrumentDistribution: Worldwide - U.S. Nationwide distribution in the states of CA, FL, GA, IA, IL, IN, KS, KY, LA, MA, MO, MS, NC, NJ, NY, OH, PA, TX, VA and WI. The countries of Argentina, Brazil, Canada, Chile, China, Cyprus, Czech Republic, Ecuador, France, Germany, Greece, Guadeloupe, India, Indonesia, Italy, Japan, Kuwait, Lebanon, Malaysia, Mexico, Pakistan, Philippines, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, South Korea, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.Recall #Z-1696-2026

Open, ClassifiedPosted Mar 30, 2026·Initiated Dec 9, 2025

Brand Name: da Vinci S, Si Double Fenestrated Grasper Instrument Product Name: da Vinci S, Si Double Fenestrated Grasper Instrument Model/Catalog Number: 420189 Software Version: NA Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories. Please refer to attached User Manual for additional details on intended use. All da Vinci S/Si reusable instruments with jaws use mechanical tungsten cables and pulleys to transmit motion from the input discs to the housing (on the proximal chassis), through the main shaft, and the distal instrument tip (inside the patient). Component: NA

Reason: Due to increased complaints for broken/frayed grip cables for reusable instruments.

Root cause: Process control

Recalling firm: Intuitive Surgical, Inc.Type: System, Surgical, Computer Controlled InstrumentDistribution: Worldwide - U.S. Nationwide distribution in the states of CA, FL, GA, IA, IL, IN, KS, KY, LA, MA, MO, MS, NC, NJ, NY, OH, PA, TX, VA and WI. The countries of Argentina, Brazil, Canada, Chile, China, Cyprus, Czech Republic, Ecuador, France, Germany, Greece, Guadeloupe, India, Indonesia, Italy, Japan, Kuwait, Lebanon, Malaysia, Mexico, Pakistan, Philippines, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, South Korea, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.Recall #Z-1697-2026

Open, ClassifiedPosted Mar 30, 2026·Initiated Dec 9, 2025

Brand Name: da Vinci S, Si Mega Needle Driver Instrument Product Name: da Vinci S, Si Mega Needle Driver Instrument Model/Catalog Number: 420194 Software Version: NA Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories. Please refer to attached User Manual for additional details on intended use. All da Vinci S/Si reusable instruments with jaws use mechanical tungsten cables and pulleys to transmit motion from the input discs to the housing (on the proximal chassis), through the main shaft, and the distal instrument tip (inside the patient). Component: NA

Reason: Due to increased complaints for broken/frayed grip cables for reusable instruments.

Root cause: Process control

Recalling firm: Intuitive Surgical, Inc.Type: System, Surgical, Computer Controlled InstrumentDistribution: Worldwide - U.S. Nationwide distribution in the states of CA, FL, GA, IA, IL, IN, KS, KY, LA, MA, MO, MS, NC, NJ, NY, OH, PA, TX, VA and WI. The countries of Argentina, Brazil, Canada, Chile, China, Cyprus, Czech Republic, Ecuador, France, Germany, Greece, Guadeloupe, India, Indonesia, Italy, Japan, Kuwait, Lebanon, Malaysia, Mexico, Pakistan, Philippines, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, South Korea, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.Recall #Z-1698-2026

Open, ClassifiedPosted Mar 30, 2026·Initiated Dec 9, 2025

Brand Name: da Vinci S, Si Grasping Retractor Instrument Product Name: da Vinci S, Si Grasping Retractor Instrument Model/Catalog Number: 420278 Software Version: NA Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories. Please refer to attached User Manual for additional details on intended use. All da Vinci S/Si reusable instruments with jaws use mechanical tungsten cables and pulleys to transmit motion from the input discs to the housing (on the proximal chassis), through the main shaft, and the distal instrument tip (inside the patient). Component: NA

Reason: Due to increased complaints for broken/frayed grip cables for reusable instruments.

Root cause: Process control

Recalling firm: Intuitive Surgical, Inc.Type: System, Surgical, Computer Controlled InstrumentDistribution: Worldwide - U.S. Nationwide distribution in the states of CA, FL, GA, IA, IL, IN, KS, KY, LA, MA, MO, MS, NC, NJ, NY, OH, PA, TX, VA and WI. The countries of Argentina, Brazil, Canada, Chile, China, Cyprus, Czech Republic, Ecuador, France, Germany, Greece, Guadeloupe, India, Indonesia, Italy, Japan, Kuwait, Lebanon, Malaysia, Mexico, Pakistan, Philippines, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, South Korea, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.Recall #Z-1699-2026

Open, ClassifiedPosted Mar 30, 2026·Initiated Dec 9, 2025

Brand Name: da Vinci S, Si Tenaculum Forceps Instrument Product Name: da Vinci S, Si Tenaculum Forceps Instrument Model/Catalog Number: 420207 Software Version: N/A Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories. Please refer to attached User Manual for additional details on intended use. All da Vinci S/Si reusable instruments with jaws use mechanical tungsten cables and pulleys to transmit motion from the input discs to the housing (on the proximal chassis), through the main shaft, and the distal instrument tip (inside the patient). Component: N/A

Reason: Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments

Root cause: Process change control

Recalling firm: Intuitive Surgical, Inc.Type: System, Surgical, Computer Controlled InstrumentDistribution: U.S. Nationwide distribution in the states of AR, CA, CT, FL, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NJ, NM, NY, NC, OH, PA, TX, VA, and WA. The countries of Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Ecuador, Egypt, France, Germany, Greece, Guadeloupe, Hong Kong, India, Indonesia, Italy, Japan, Kuwait, Lebanon, Malaysia, Mexico, Pakistan, Philippines, Portugal, Qatar, Romania, Russian Federation, Rwanda, Saudi Arabia, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.Recall #Z-1700-2026

Open, ClassifiedPosted Mar 30, 2026·Initiated Dec 9, 2025

Brand Name: da Vinci S, Si Permanent Cautery Hook Instrument Product Name: da Vinci S, Si Permanent Cautery Hook Instrument Model/Catalog Number: 420183 Software Version: NA Product Description: EndoWrist Instruments or da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories. Please refer to attached User Manual for additional details on intended use. All da Vinci S/Si reusable instruments with jaws use mechanical tungsten cables and pulleys to transmit motion from the input discs to the housing (on the proximal chassis), through the main shaft, and the distal instrument tip (inside the patient). Component: NA

Reason: Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments

Root cause: Process change control

Recalling firm: Intuitive Surgical, Inc.Type: System, Surgical, Computer Controlled InstrumentDistribution: U.S. Nationwide distribution in the states of AR, CA, CT, FL, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NJ, NM, NY, NC, OH, PA, TX, VA, and WA. The countries of Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Ecuador, Egypt, France, Germany, Greece, Guadeloupe, Hong Kong, India, Indonesia, Italy, Japan, Kuwait, Lebanon, Malaysia, Mexico, Pakistan, Philippines, Portugal, Qatar, Romania, Russian Federation, Rwanda, Saudi Arabia, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.Recall #Z-1701-2026

Open, ClassifiedPosted Mar 30, 2026·Initiated Feb 25, 2026

2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US.

Reason: A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8, resulting in the bones taps having an incorrect thread.

Root cause: Process change control

Recalling firm: Synthes (USA) Products LLCType: Tap, BoneDistribution: US Nationwide distribution in the states of AR, AZ, CA, CO, FL, IN, LA, MD, MN, NC, NJ, OH, OK, OR, PA, TN, TX, UT, VA, WA, WI.Recall #Z-1702-2026

Open, ClassifiedPosted Mar 30, 2026·Initiated Feb 25, 2026

2.4 VOLT(TM) TAP CORTEX SCREW TO 90MM. Part Number: 03.424.126-US.

Reason: A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8, resulting in the bones taps having an incorrect thread.

Root cause: Process change control

Recalling firm: Synthes (USA) Products LLCType: Tap, BoneDistribution: US Nationwide distribution in the states of AR, AZ, CA, CO, FL, IN, LA, MD, MN, NC, NJ, OH, OK, OR, PA, TN, TX, UT, VA, WA, WI.Recall #Z-1703-2026

Open, ClassifiedPosted Mar 30, 2026·Initiated Jul 21, 2025

Brand Name: Finesse BTK Multicath Product Name: Injectable Angioplasty Balloon Catheter Model/Catalog Number: FS252251502 Product Description: 5 French sheath, 0.014" guidewire compatible over-the-wire injectable angioplasty balloon catheter, balloon diameter 2.5mm, balloon length 225mm, catheter working length 150cm Component: NA

Reason: Potential for the balloon in the device to not meet burst specifications.

Root cause: Process control

Recalling firm: SUMMA THERAPEUTICS, LLCType: Catheter, Angioplasty, Peripheral, TransluminalDistribution: US Nationwide distribution in the states of New Jersey, Florida.Recall #Z-1704-2026

Open, ClassifiedPosted Mar 27, 2026·Initiated Feb 16, 2026

Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 3. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 4. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 5. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 6. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK. 7. Optical AIC w/Impella Connect, Pack'd, CA; Product Code: 0042-0040-CA. 8. Optical AIC w/Impella Connect, Pack'd, EU; Product Code: 0042-0040-EU. 9. Optical, AIC, Impella Connect, Pkgd, AU; Product Code: 0042-0040-AU.

Reason: Potential that the "Purge System Blocked" alarm display on the Automated Impella Controller (AIC) could be delayed when using first generation Impella 5.5 (0550-0008*) pumps.

Root cause: Software design

Recalling firm: Abiomed, Inc.Type: Temporary Non-Roller Type Left Heart Support Blood PumpDistribution: International distribution in the country of Australia, Canada, France, Germany, Kuwait.Recall #Z-1591-2026

Open, ClassifiedPosted Mar 27, 2026·Initiated Feb 10, 2026

Puracol and Puracol Plus Collagen Wound Dressings: MSC8522 DRESSING,COLLAGEN,PURACOL,STRL,2" X 2" MSC8622EP DRESSING,COLLAGEN,PURACOL PLUS, 2X2.2"

Reason: Elevated endotoxin levels identified in affected lots. Issue may elicit strong inflammatory response if used, including local tissue irritation, delayed wound healing, or systemic effects such as fever and hypotension. In severe cases, septic shock may result.

Root cause: Under Investigation by firm

Recalling firm: Medline Industries, LPType: Wound Dressing With Animal-Derived Material(S)Distribution: Domestic distribution nationwide US. International distribution to Mexico and Panama.Recall #Z-1650-2026

Open, ClassifiedPosted Mar 27, 2026·Initiated Feb 11, 2026

Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;

Reason: The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are correct.

Root cause: Under Investigation by firm

Recalling firm: Waldemar Link GmbH & Co. KG (Mfg Site)Type: Bit, DrillDistribution: US distribution to states of: AL, AZ, FL, GA, IL, IN, KS, KY, LA, MI, NC, OH, OK, TX, VARecall #Z-1651-2026

Open, ClassifiedPosted Mar 27, 2026·Initiated Feb 11, 2026

Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;

Reason: The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are correct.

Root cause: Under Investigation by firm

Recalling firm: Waldemar Link GmbH & Co. KG (Mfg Site)Type: Bit, DrillDistribution: US distribution to states of: AL, AZ, FL, GA, IL, IN, KS, KY, LA, MI, NC, OH, OK, TX, VARecall #Z-1652-2026

Open, ClassifiedPosted Mar 27, 2026·Initiated Jan 29, 2026

Brand Name: Paradise Ultrasound Renal Denervation System Product Name: Paradise Catheter Model/Catalog Number: PRDS-068-02 Product Description: Common name: Ablation catheter renal denervation

Reason: Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use.

Root cause: Under Investigation by firm

Recalling firm: ReCor Medical Inc.Type: Ablation Catheter, Renal DenervationDistribution: U.S. Nationwide distribution in the states of CA, CO, FL, KS, MO, NC, OH, TX, and VA.Recall #Z-1654-2026

Open, ClassifiedPosted Mar 27, 2026·Initiated Jan 29, 2026

Brand Name: Paradise Ultrasound Renal Denervation System Product Name: Paradise Catheter Model/Catalog Number: PRDS-068-02 Product Description: Common name: Ablation catheter renal denervation

Reason: Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use.

Root cause: Under Investigation by firm

Recalling firm: ReCor Medical Inc.Type: Ablation Catheter, Renal DenervationDistribution: U.S. Nationwide distribution in the states of CA, CO, FL, KS, MO, NC, OH, TX, and VA.Recall #Z-1655-2026

Open, ClassifiedPosted Mar 27, 2026·Initiated Feb 9, 2026

RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00

Reason: Due to a radiotherapy medical system software defect, when performing angular roll corrections followed by a repeat localization, the roll corrections applied in the initial localization scan are not carried through to treatment delivery leading to the treatment plan dose being delivered to the incorrect location, potentially a displacement of 5mm or higher, with a 10% to 20% underdose.

Root cause: Software change control

Recalling firm: Reflexion Medical, Inc.Type: Fludeoxyglucose F18-Guided Radiation Therapy SystemDistribution: US: CA, TX, PA, CT, NJ, OR, LA, OHRecall #Z-1656-2026

Open, ClassifiedPosted Mar 27, 2026·Initiated Feb 23, 2026

Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;

Reason: A potential for depressed results for Atellica CH A1c_E when processing Atellica CH RCRP on the same analyzer. Customers processing A1c_E and RCRP on separate analyzers are not impacted by the recall. The frequency and magnitude of the negative bias and imprecision increase over time and are not consistent with the assay Instructions For Use (IFU). When this issue is present, Quality Control (QC) results demonstrate a negative trend and increased imprecision. The clinical impact of a negative (A1c_E) bias may lead to a delay in diagnosis for diabetes or lead to less-than-optimal treatment for existing diabetes.

Root cause: Process control

Recalling firm: Siemens Healthcare Diagnostics, Inc.Type: Hemoglobin A1c Test SystemDistribution: Domestic: Nationwide Distribution International: Argentina, Australia, Bangladesh, Brazil, Bulgaria , Canada, Chile, China, Colombia, Croatia , Cura¿ao, St Eus, Czech Republic , Denmark , Ecuador, Egypt , Estonia , Finland , France , Georgia , Germany , Greece , Hong Kong, India, Iraq , Italy , Jordan , Kuwait , Latvia , Lithuania , Macedonia , Malaysia, Maldives, Mexico, Netherlands , New Zealand, Norway , Oman , Pakistan , Paraguay, Qatar , Romania , Saudi Arabia , Serbia , Singapore, Slovakia , Slovenia , South Africa, South Korea, Spain , Turkey , Turkmenistan , U.A.E. , Uganda , United Kingdom , Uruguay , Vatikancity;Recall #Z-1657-2026

Open, ClassifiedPosted Mar 27, 2026·Initiated Feb 6, 2026

BD Kiestra" ReadA; Catalog No.: 446948.

Reason: In certain situations, following a system reboot, one or more modules may have become unreachable via the remote connectivity interface. When this occurred, there was potential for delays in plate retrieval from the incubator while connectivity was restored. This issue was intermittent and did not affect test results, performance of the assay, or sample integrity.

Root cause: Software Manufacturing/Software Deployment

Recalling firm: BD KIESTRA LAB AUTOMATIONType: Bath, Incubators/Water, AllDistribution: Domestic: KS, MD, MN, NJ, TX, VA; International: Australia, Austria, Belgium, Canada, China, Denmark, France, Germany, Hong Kong, Italy, Kuwait, Mexico, Morocco, Netherlands, Norway, Saudi Arabia, Spain, Sweden, Switzerland, Taiwan, United Kingdom;Recall #Z-1658-2026