These recalls involve products that pose serious risks of injury or death. Check if you own any of these products and take immediate action if needed.

Immediate attention

High Risk Recalls

4,262 critical product recalls that require immediate attention. These products have been identified as posing serious safety hazards.

High-risk recalls: 4,262
Action level: Stop use

What to do if you own a recalled product

Stop using the product immediately
Keep the product away from children
Follow the remedy instructions provided
Contact the manufacturer for a refund or replacement

HIGH

FDA DEVICE

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

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

Apr 30, 2026

SURGIFY MEDICAL OY

Potential for

HIGH

FDA DEVICE

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

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

Apr 30, 2026

SURGIFY MEDICAL OY

Potential for

HIGH

FDA DEVICE

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

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

Apr 30, 2026

SURGIFY MEDICAL OY

Potential for

HIGH

FDA DEVICE

Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.U1; drills, burrs, trephines & accessories (simple, powered)

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

Apr 30, 2026

SURGIFY MEDICAL OY

Potential for

HIGH

FDA DEVICE

Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.H1; drills, burrs, trephines & accessories (simple, powered)

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

Apr 30, 2026

SURGIFY MEDICAL OY

Potential for

HIGH

FDA DEVICE

Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.U1; drills, burrs, trephines & accessories (simple, powered)

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

Apr 30, 2026

SURGIFY MEDICAL OY

Potential for

HIGH

FDA DEVICE

Surgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.H1; drills, burrs, trephines & accessories (simple, powered)

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

Apr 30, 2026

SURGIFY MEDICAL OY

Potential for

HIGH

FDA DEVICE

Surgify Halo, 3.0 mm, Long, Model/Catalog Number: 30.125.NVG.U2; drills, burrs, trephines & accessories (simple, powered)

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

Apr 30, 2026

SURGIFY MEDICAL OY

Potential for

HIGH

FDA DEVICE

Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.H1; drills, burrs, trephines & accessories (simple, powered)

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

Apr 30, 2026

SURGIFY MEDICAL OY

Potential for

HIGH

FDA DEVICE

Surgify Halo, 3.0 mm, Short, Model/Catalog Number: 30.070.NVG.U2; drills, burrs, trephines & accessories (simple, powered)

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

Apr 30, 2026

SURGIFY MEDICAL OY

Potential for

HIGH

FDA DEVICE

Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.H1; drills, burrs, trephines & accessories (simple, powered)

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

Apr 30, 2026

SURGIFY MEDICAL OY

Potential for

HIGH

FDA DEVICE

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

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

Apr 30, 2026

SURGIFY MEDICAL OY

Potential for

HIGH

FDA DEVICE

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, ...

Apr 30, 2026

Medacta Usa

Surgical instruments

HIGH

FDA DEVICE

Mahurkar Elite PASS Trays; Description (Product Number/CFN): 12 FR x 13cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221413), 12 FR x 16cm Acute Dual Lumen Catheter with...

The Tegaderm CHG dressing, as specified in product labeling, was missing from certain lots of Mahurkar Elite PASS Trays.

Apr 29, 2026

Mozarc Medical US

The Tegaderm

HIGH

FDA DEVICE

Boston Scientific TCN Electrodes: REF: TCN-5, TCN Electrode, NITINOL, 5 cm x 0.45 mm (0.0175 in); REF:TCN-10, TCN Electrode, NITINOL, 10 cm x 0.45 mm (0.0175 in) REF:TCN-15, TCN Electrode,...

Reusable electrodes may not meet expected performance levels.

Apr 29, 2026

Boston Scientific Neuromodulation

Reusable electrodes

HIGH

FDA DEVICE

Plum Duo Precision IV Pump, 40002-0403

Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.

Apr 29, 2026

ICU Medical

Under certain

HIGH

FDA DRUG

Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-098-09, b) 30 capsules, NDC 27241-098-03, c) 1000 Capsules, NDC 27241-098-10, Marketed by: Ajanta Pharma USA Inc.,...

CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.

Apr 29, 2026

DULOXETINE

CGMP Deviations:

HIGH

FDA DRUG

Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-097-06.

CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.

Apr 29, 2026

DULOXETINE

CGMP Deviations:

HIGH

FDA DRUG

Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-099-03

CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.

Apr 29, 2026

DULOXETINE

CGMP Deviations:

HIGH

FDA DRUG

Erythromycin Tablets, USP, 500 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534;...

CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit

Apr 29, 2026

ERYTHROMYCIN

CGMP Deviations;

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