Medical device recalls

FDA recalls of medical devices including diagnostics, implants, and consumer health hardware.

601–625 of 13418

HighFDA (Devices)·Z-1602-2026·2026-04-01
[pending] Distal Humeral Plates with Angular Stability with the below descriptions and corresponding article n
Pending LLM rewrite. Source: FDA_DEVICE Z-1602-2026.
Product
Distal Humeral Plates with Angular Stability with the below descriptions and corresponding article numbers. 1. Cortical Screw, Locking; Article Numbers: 37351-10-N, 37351-12-N, 37351-14-N, 37351-16-N, 37351-18-N, 37351-20-N, 37351-22-N, 37351-24-N, 37351-26-N, 37351-28-N, 373
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1575-2026·2026-04-01
[pending] CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENFP19K/A, CENFP23K/A,
Pending LLM rewrite. Source: FDA_DEVICE Z-1575-2026.
Product
CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/A, CENFP31K/A, CENFT15K, CENFT15K/D, CENFT17K, CENFT17K/A, CENFT17K/D, CENFT19K, CENFT19K/A, CENFT19K/B, CENFT19K/D, CENFT23K, CENFT23K/A, CENFT23K/B, CENFT23K/D, CENFT27K
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1568-2026·2026-04-01
[pending] Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use
Pending LLM rewrite. Source: FDA_DEVICE Z-1568-2026.
Product
Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1598-2026·2026-04-01
[pending] I.T.S. Straight Plate with Angular Stability with the below descriptions and corresponding article n
Pending LLM rewrite. Source: FDA_DEVICE Z-1598-2026.
Product
I.T.S. Straight Plate with Angular Stability with the below descriptions and corresponding article numbers. 1. Forearm Plate, Curved; Article Numbers: 21604-6, 21604-9. 2. Forearm Plate, Straight; Article Numbers: 21605-11, 21605-6, 21605-9. 3. Straight Compression Pla
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1608-2026·2026-04-01
[pending] Brand Name: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) with the below descriptions a
Pending LLM rewrite. Source: FDA_DEVICE Z-1608-2026.
Product
Brand Name: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) with the below descriptions and corresponding article numbers. 1. Anterior Column Plate; Article Numbers: 21218-16, 21219-16. 2. Anterior Column Plate; Article Numbers: 21218-14, 21219-14. 3. Biplanar 2-C
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1610-2026·2026-04-01
[pending] Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.
Pending LLM rewrite. Source: FDA_DEVICE Z-1610-2026.
Product
Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1576-2026·2026-04-01
[pending] ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-N
Pending LLM rewrite. Source: FDA_DEVICE Z-1576-2026.
Product
ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-NE5/C, DC21454035/C, DC21455550/C
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1643-2026·2026-04-01
[pending] Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS Cutting Forceps Model/C
Pending LLM rewrite. Source: FDA_DEVICE Z-1643-2026.
Product
Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920000PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. Coagulation is achieved using electrosurgical energy under
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1590-2026·2026-04-01
[pending] Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Num
Pending LLM rewrite. Source: FDA_DEVICE Z-1590-2026.
Product
Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E85101LP
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1615-2026·2026-04-01
[pending] Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator devi
Pending LLM rewrite. Source: FDA_DEVICE Z-1615-2026.
Product
Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1613-2026·2026-04-01
[pending] Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.
Pending LLM rewrite. Source: FDA_DEVICE Z-1613-2026.
Product
Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1645-2026·2026-04-01
[pending] BD Alaris" System with Guardrails" Suite MX with Point of Care Unit
Pending LLM rewrite. Source: FDA_DEVICE Z-1645-2026.
Product
BD Alaris" System with Guardrails" Suite MX with Point of Care Unit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1627-2026·2026-04-01
[pending] Philips X3-1 Ultrasound Transducer
Pending LLM rewrite. Source: FDA_DEVICE Z-1627-2026.
Product
Philips X3-1 Ultrasound Transducer
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1623-2026·2026-04-01
[pending] Philips OMNI II TEE Ultrasound Transducer
Pending LLM rewrite. Source: FDA_DEVICE Z-1623-2026.
Product
Philips OMNI II TEE Ultrasound Transducer
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1640-2026·2026-04-01
[pending] Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Forceps Model/Catalog Nu
Pending LLM rewrite. Source: FDA_DEVICE Z-1640-2026.
Product
Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Forceps Model/Catalog Number: PK-CF0533 Product Description: An assembly of devices intended to generate and apply radio-frequency (RF) alternating current to soft tissues for cutting and coagulation dur
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1635-2026·2026-04-01
[pending] MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61
Pending LLM rewrite. Source: FDA_DEVICE Z-1635-2026.
Product
MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1651-2026·2026-04-01
[pending] Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;
Pending LLM rewrite. Source: FDA_DEVICE Z-1651-2026.
Product
Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;
Category
Medical Device
Distribution
15 states
HighFDA (Devices)·Z-1577-2026·2026-04-01
[pending] 16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/B
Pending LLM rewrite. Source: FDA_DEVICE Z-1577-2026.
Product
16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1636-2026·2026-04-01
[pending] Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin
Pending LLM rewrite. Source: FDA_DEVICE Z-1636-2026.
Product
Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to deliver insulin from within a disposable cartridge, through an infusion set, into a patient s subcutaneous tissue. As with current i
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1612-2026·2026-04-01
[pending] Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.
Pending LLM rewrite. Source: FDA_DEVICE Z-1612-2026.
Product
Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1603-2026·2026-04-01
[pending] I.T.S. LRS (Locking Reconstruction System) with the below descriptions and corresponding article num
Pending LLM rewrite. Source: FDA_DEVICE Z-1603-2026.
Product
I.T.S. LRS (Locking Reconstruction System) with the below descriptions and corresponding article numbers. 1. DFL (Distal Femur Locking) Distal Femur Plate; Article Numbers: 21301-5, 21301-7, 21301-9, 21301-13, 21302-5, 21302-7, 21302-9, 21302-13. 2. PTL (Proximal Lateral
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1621-2026·2026-04-01
[pending] Philips L17-5 Ultrasound Transducer
Pending LLM rewrite. Source: FDA_DEVICE Z-1621-2026.
Product
Philips L17-5 Ultrasound Transducer
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1579-2026·2026-04-01
[pending] BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU, H965103028031/A, H
Pending LLM rewrite. Source: FDA_DEVICE Z-1579-2026.
Product
BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU, H965103028031/A, H965103028031/EU, H965103028041/A, H965103028041/EU, H965103028051/A, H965103028051/EU, H965103028061/A, H965103028061/EU, H965103028070/A, H965103028070/EU, H965103028080/A, H96510
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1588-2026·2026-04-01
[pending] Handy Solutions Neck & Shoulders Heating Pad, Number: 25607, Manufactured by Ninbo Unico Products Co
Pending LLM rewrite. Source: FDA_DEVICE Z-1588-2026.
Product
Handy Solutions Neck & Shoulders Heating Pad, Number: 25607, Manufactured by Ninbo Unico Products Co., Ltd
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1611-2026·2026-04-01
[pending] Olympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444.
Pending LLM rewrite. Source: FDA_DEVICE Z-1611-2026.
Product
Olympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444.
Category
Medical Device
Distribution
Distributed nationwide

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