Medical device recalls

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

476–500 of 13395

HighFDA (Devices)·Z-1698-2026·2026-04-08
[pending] Brand Name: da Vinci S, Si Mega Needle Driver Instrument Product Name: da Vinci S, Si Mega Needle D
Pending LLM rewrite. Source: FDA_DEVICE Z-1698-2026.
Product
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 en
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1672-2026·2026-04-08
[pending] Allura Xper FD20/15 OR Table; System Code: 722059;
Pending LLM rewrite. Source: FDA_DEVICE Z-1672-2026.
Product
Allura Xper FD20/15 OR Table; System Code: 722059;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1738-2026·2026-04-08
[pending] eTRAX Needle Sensor - 18G (for Aurora Trackers), Part Number 667-159
Pending LLM rewrite. Source: FDA_DEVICE Z-1738-2026.
Product
eTRAX Needle Sensor - 18G (for Aurora Trackers), Part Number 667-159
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-1747-2026·2026-04-08
[pending] MiniMed 620G Insulin Pump (MMT-1750)
Pending LLM rewrite. Source: FDA_DEVICE Z-1747-2026.
Product
MiniMed 620G Insulin Pump (MMT-1750)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1702-2026·2026-04-08
[pending] 2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US.
Pending LLM rewrite. Source: FDA_DEVICE Z-1702-2026.
Product
2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1673-2026·2026-04-08
[pending] Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229;
Pending LLM rewrite. Source: FDA_DEVICE Z-1673-2026.
Product
Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1733-2026·2026-04-08
[pending] eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151
Pending LLM rewrite. Source: FDA_DEVICE Z-1733-2026.
Product
eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-1676-2026·2026-04-08
[pending] Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;
Pending LLM rewrite. Source: FDA_DEVICE Z-1676-2026.
Product
Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1705-2026·2026-04-08
[pending] Airway Exam Kit, DYKE1796
Pending LLM rewrite. Source: FDA_DEVICE Z-1705-2026.
Product
Airway Exam Kit, DYKE1796
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1748-2026·2026-04-08
[pending] Paradigm Insulin Pump (MMT-712, MMT-715)
Pending LLM rewrite. Source: FDA_DEVICE Z-1748-2026.
Product
Paradigm Insulin Pump (MMT-712, MMT-715)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1736-2026·2026-04-08
[pending] eTRAX Needle Sensor - 14G(for Aurora Trackers), Part Number 667-157
Pending LLM rewrite. Source: FDA_DEVICE Z-1736-2026.
Product
eTRAX Needle Sensor - 14G(for Aurora Trackers), Part Number 667-157
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-1679-2026·2026-04-08
[pending] Azurion 5 M12; System Code: (1)722227, (2)722231;
Pending LLM rewrite. Source: FDA_DEVICE Z-1679-2026.
Product
Azurion 5 M12; System Code: (1)722227, (2)722231;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1766-2026·2026-04-08
[pending] OXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria identification sysystem
Pending LLM rewrite. Source: FDA_DEVICE Z-1766-2026.
Product
OXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria identification sysystem
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1732-2026·2026-04-08
[pending] eTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-150
Pending LLM rewrite. Source: FDA_DEVICE Z-1732-2026.
Product
eTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-150
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-1762-2026·2026-04-08
[pending] Burlington Medical, Half Aprons.
Pending LLM rewrite. Source: FDA_DEVICE Z-1762-2026.
Product
Burlington Medical, Half Aprons.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1754-2026·2026-04-08
[pending] Burlington Medical, Vest
Pending LLM rewrite. Source: FDA_DEVICE Z-1754-2026.
Product
Burlington Medical, Vest
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1746-2026·2026-04-08
[pending] MiniMed 740G Insulin Pump (MMT-1811, MMT-1812, MMT-1861, MMT-1862)
Pending LLM rewrite. Source: FDA_DEVICE Z-1746-2026.
Product
MiniMed 740G Insulin Pump (MMT-1811, MMT-1812, MMT-1861, MMT-1862)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1591-2026·2026-04-08
[pending] Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1
Pending LLM rewrite. Source: FDA_DEVICE Z-1591-2026.
Product
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; Produc
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1666-2026·2026-04-08
[pending] ALLURA Xper FD20 Biplane OR Table; System Code: (1) 722020, (2)722025;
Pending LLM rewrite. Source: FDA_DEVICE Z-1666-2026.
Product
ALLURA Xper FD20 Biplane OR Table; System Code: (1) 722020, (2)722025;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1694-2026·2026-04-08
[pending] Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Premium Laser Sy
Pending LLM rewrite. Source: FDA_DEVICE Z-1694-2026.
Product
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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1763-2026·2026-04-08
[pending] Burlington Medical, Demi Half Aprons.
Pending LLM rewrite. Source: FDA_DEVICE Z-1763-2026.
Product
Burlington Medical, Demi Half Aprons.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1660-2026·2026-04-08
[pending] ALLURA Xper FD10F; System Code: 722002;
Pending LLM rewrite. Source: FDA_DEVICE Z-1660-2026.
Product
ALLURA Xper FD10F; System Code: 722002;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1657-2026·2026-04-08
[pending] Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;
Pending LLM rewrite. Source: FDA_DEVICE Z-1657-2026.
Product
Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1681-2026·2026-04-08
[pending] CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, 3549313, 354-9314 S
Pending LLM rewrite. Source: FDA_DEVICE Z-1681-2026.
Product
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, 3549313, 354-9314 SILTEX Low Height Tissue Expander Style (9100, 450cc), (9300, 450cc), (9300, 550cc)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1750-2026·2026-04-08
[pending] Paradigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723)
Pending LLM rewrite. Source: FDA_DEVICE Z-1750-2026.
Product
Paradigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723)
Category
Medical Device
Distribution
Distributed nationwide

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