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  1. FDA Recalls
  2. ›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 221–240 of 1,000 recalls

Class IIOngoing

Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PULL Model/Catalog Number: 7180-20

Avanos Medical, Inc.

Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.

April 30, 2026 · DeviceView details →
Class IIOngoing

Halyard, Drape Pack. Kit Code: LMDP36-01.

AVID Medical, Inc.

Inadvertent distribution of sealed pouches that had not undergone validated sterilization.

April 30, 2026 · DeviceView details →
Class IIOngoing

Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, 722221), Azurion 3 M15 (722064, 722222), Azurion 5 M12 (722227), Azurion 5 M20 (722228), Azurion 7 B12 (722067, 722225), Azurion 7 B20 (722068, 722226), Azurion 7 M12 (722078, 722223), Azurion 7 M20 (722079, 722224).

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of service. Issues with an HDD may, depending on the specific system PC in which the affected HDD is installed, result in loss of imaging functionality. Additionally, in Allura systems, this may lead to loss of motorized movement, or loss of data. In some cases, a system restart may temporarily restore functionality.

April 30, 2026 · DeviceView details →
Class IIOngoing

BD Pyxis Anesthesia Station ES REF: 327 Medication cabinet

CareFusion 303, Inc.

Fingerprint scanner may overheat to a temperature to cause 1st degree burn.

April 30, 2026 · DeviceView details →
Class IIOngoing

Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.U1; drills, burrs, trephines & accessories (simple, powered)

SURGIFY MEDICAL OY

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

April 30, 2026 · DeviceView details →
Class IIOngoing

BD Pyxis MedStation 4000 REF: 303 Medication cabinet

CareFusion 303, Inc.

Fingerprint scanner may overheat to a temperature to cause 1st degree burn.

April 30, 2026 · DeviceView details →
Class IIOngoing

Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PULL Model/Catalog Number: 8180-20

Avanos Medical, Inc.

Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.

April 30, 2026 · DeviceView details →
Class IIOngoing

Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.U1; drills, burrs, trephines & accessories (simple, powered)

SURGIFY MEDICAL OY

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

April 30, 2026 · DeviceView details →
Class IIOngoing

Surgify Halo, 3.0 mm, Extendable, Model/Catalog Number: 30.000.SEE.U2; drills, burrs, trephines & accessories (simple, powered)

SURGIFY MEDICAL OY

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

April 30, 2026 · DeviceView details →
Class IIOngoing

Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PUSH OTW Model/Catalog Number: 7170-14 Product Description: Feeding Tube Kit

Avanos Medical, Inc.

Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.

April 30, 2026 · DeviceView details →
Class IIOngoing

Surgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.U1; drills, burrs, trephines & accessories (simple, powered)

SURGIFY MEDICAL OY

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

April 30, 2026 · DeviceView details →
Class IIOngoing

Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.H1; drills, burrs, trephines & accessories (simple, powered)

SURGIFY MEDICAL OY

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

April 30, 2026 · DeviceView details →
Class IIOngoing

Halyard, Eye Bag Pack. Kit Code: UIEB48-01.

AVID Medical, Inc.

Inadvertent distribution of sealed pouches that had not undergone validated sterilization.

April 30, 2026 · DeviceView details →
Class IIOngoing

Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10 OR Table (722022, 722033), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039);

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of service. Issues with an HDD may, depending on the specific system PC in which the affected HDD is installed, result in loss of imaging functionality. Additionally, in Allura systems, this may lead to loss of motorized movement, or loss of data. In some cases, a system restart may temporarily restore functionality.

April 30, 2026 · DeviceView details →
Class IIOngoing

TDC VELOCE", 25G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT25, 9311.25G01, 9311.25G02, 9311.25K01, 9311.25K02, 9311.25K03, 9625.G0201;

D.O.R.C. Dutch Opthalmic Research Center Intl B.V.

An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.

April 30, 2026 · DeviceView details →
Class IIOngoing

BD Pyxis MedBank Mini REF: 1147-00 Medication cabinet

CareFusion 303, Inc.

Fingerprint scanner may overheat to a temperature to cause 1st degree burn.

April 30, 2026 · DeviceView details →
Class IIOngoing

Surgify Halo, 40 mm, Long, Model/Catalog Number: 40.125.NVG.U1; drills, burrs, trephines & accessories (simple, powered)

SURGIFY MEDICAL OY

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

April 30, 2026 · DeviceView details →
Class IIOngoing

Short Monobloc Stem Broaches, Size/REF: 7/04.01.10.0970, 8/04.01.10.0971, 9/04.01.10.0972, 10/04.01.10.0973, 11/04.01.10.0974, 12/04.01.10.0975, 13/04.01.10.0976, 14/04.01.10.0977, 15/04.01.10.0978, 16/04.01.10.0979 Part of Medacta Shoulder System

Medacta Usa Inc

Surgical instruments used during shoulder arthroplasty procedures does not progressively translate to replicate implant geometry, so the reaming guide and the stem reamer are positioned approximately 0.2 mm per size more laterally than intended, which may increase the risk of fracture in the medial region of the proximal humerus.

April 30, 2026 · DeviceView details →
Class IIOngoing

directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2

Accriva Diagnostics, Inc.

Assayed Whole blood control contains labeling with incorrect performance range.

April 30, 2026 · DeviceView details →
Class IIOngoing

BD Pyxis MedStation ES Tower REF: 352 Medication cabinet

CareFusion 303, Inc.

Fingerprint scanner may overheat to a temperature to cause 1st degree burn.

April 30, 2026 · DeviceView details →
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