burn risk Recalls

471 recalls tagged with “burn risk”.

Health & Personal Care
HIGH
FDA DEVICE

I.T.S. GmbH LRS Orthopedic System Recall: 176 Units for MRI Heating Risk (2026)

ITS GmbH recalled 176 units nationwide in the United States after MRI safety testing showed higher RF-induced temperature increases under certain MRI conditions. The issue could cause burns during MRI exposure. Healthcare providers and patients should stop using the device immediately and follow recall instructions.

I.T.S. GmbH
Updated MRI
Read more
Health & Personal Care
HIGH
FDA DEVICE

ITS GmbH Recalled 11 Pelvic Reconstruction System PRS Components for MRI Heating Risk (2026)

ITS GmbH recalled 11 Pelvic Reconstruction System PRS components after MRI safety testing showed higher RF-induced temperature increases under certain MRI conditions than described in the IFU. The recall covers Fixation Screw 70312 and Spike short 70314. Healthcare providers and patients should stop using the devices and follow the manufacturer’s recall instructions provided by email.

I.T.S. GmbH
Updated MRI
Read more
Health & Personal Care
HIGH
FDA DEVICE

ITS GmbH Pilon Plate with Angular Stability Recalled for MRI Heating Risk (2026) 101 Units

ITS GmbH recalls 101 Pilon Plate with Angular Stability implants distributed nationwide in the United States. Updated MRI safety testing shows higher RF-induced temperature increases under certain MRI conditions than described in the IFU. Patients and healthcare providers should stop using the device immediately and follow recall instructions.

I.T.S. GmbH
Updated MRI
Read more
Health & Personal Care
HIGH
FDA DEVICE

I.T.S. FR.O.H. Calcaneus Plate Recalled for MRI Heating Risk in 4 Units (2026)

I.T.S. GmbH is recalling the FR.O.H. Calcaneus Repair System, Anterolateral Calcaneus Plate, 4 units, distributed nationwide in the United States. Updated MRI safety testing shows higher RF-induced temperature increases under certain MRI conditions than described in the IFU. Healthcare providers should stop using the device immediately and follow the manufacturer’s recall instructions.

I.T.S. GmbH
Updated MRI
Read more
Health & Personal Care
HIGH
FDA DEVICE

ITS Fibula Plate PROlock with Angular Stability Recall Affects 869 Units (2026)

ITS recalls 869 Fibula Plate PROlock with Angular Stability implants distributed nationwide in the United States. Updated MRI safety testing shows higher RF-induced temperature increases under certain MRI conditions than previously reflected in the IFU. Hospitals and healthcare providers should stop using this device immediately and follow the recall instructions.

I.T.S. GmbH
Updated MRI
Read more
Health & Personal Care
HIGH
FDA DEVICE

I.T.S. GmbH Claviculaplate with Angular Stability Recalled for MRI Heating Risk 322 Units (2026)

I.T.S. GmbH recalled 322 Claviculaplate with Angular Stability devices sold nationwide in the United States. Updated MRI safety testing shows higher RF-induced temperature increases under certain MRI conditions than the IFU reflected. Healthcare providers and patients should stop using the device immediately and follow recall instructions from the manufacturer.

I.T.S. GmbH
Updated MRI
Read more
Health & Personal Care
HIGH
FDA DEVICE

I.T.S. GmbH Distal Humeral Plates Recalled for MRI Heating Risk — 12,059 Units (2026)

I.T.S. GmbH recalled 12,059 Distal Humeral Plates with Angular Stability due to MRI heating risk. Updated MRI safety testing shows higher RF-induced temperature increases under certain MRI conditions than reflected in the IFU. Healthcare providers and patients should stop using the device and follow recall instructions.

I.T.S. GmbH
Updated MRI
Read more
Health & Personal Care
HIGH
FDA DEVICE

I.T.S. GmbH Recalls 15,517 FLS Foot Locking Plates System and Hallux Osteotomy Plates Over MRI Heat‑

I.T.S. GmbH recalled 15,517 FLS Foot Locking Plates System and HOL Hallux Osteotomy locking plates distributed nationwide in the United States. Updated MRI safety testing shows higher RF-induced temperature increases under certain MRI conditions than previously reflected in the IFU. Patients and healthcare providers should stop using this device immediately and follow the recall instructions from:

I.T.S. GmbH
Updated MRI
Read more
Health & Personal Care
HIGH
FDA DEVICE

ITS Recalls 70 Olecranon Plates Over MRI RF Heating Risk (2026)

ITS recalls 70 Olecranon Plates with Angular Stability distributed nationwide in the United States. Updated MRI safety testing shows higher RF-induced temperature increases under certain MRI conditions than described in the IFU. Patients and healthcare providers should stop using this device immediately and contact ITS or their healthcare provider for instructions.

I.T.S. GmbH
Updated MRI
Read more
Health & Personal Care
HIGH
FDA DEVICE

ITS GmbH Recalls 623 HCS Headless Cannulated Screws Over MRI Heating Risk (2026)

ITS GmbH recalled 623 HCS Headless Cannulated Screws distributed nationwide to U.S. healthcare facilities. The defect involves higher RF-induced temperature increases during certain MRI procedures than the IFU described. Affected patients and providers should stop using immediately and follow recall instructions. Contact ITS GmbH or your healthcare provider for instructions.

I.T.S. GmbH
Updated MRI
Read more
Health & Personal Care
HIGH
FDA DEVICE

ITS GmbH HLS Hand Locking Plates System Recalled for MRI Heating Risk (1,307 Units, 2026)

ITS GmbH recalled 1,307 units of the HLS Hand Locking Plates System distributed nationwide in the United States after MRI safety testing showed higher RF-induced temperature increases. The issue exceeds what is described in the IFU under certain MRI conditions. Patients and healthcare providers should stop using the device immediately and follow ITS GmbH's recall instructions.

I.T.S. GmbH
Updated MRI
Read more
Health & Personal Care
HIGH
FDA DEVICE

ITS GmbH Humeral Head Plate MRI Recall Affects 292 Units in 2026

ITS GmbH recalled 292 proximal humeral plates nationwide in the United States after MRI safety testing showed higher RF-induced heating under certain MRI conditions. The heating can occur during MRI and may cause burns or tissue damage. Patients and clinicians should stop using the device immediately and follow the recall instructions from ITS GmbH and their healthcare providers.

I.T.S. GmbH
Updated MRI
Read more
Health & Personal Care
HIGH
FDA DEVICE

I.T.S. Ulna Locking Plate Systems Recalled Over MRI Heating Risk (2026)

I.T.S. GmbH recalled 120 units of its DUL and UOL ulna locking plate systems distributed nationwide to U.S. healthcare providers after MRI safety testing showed higher RF-induced heating. The updated testing found temperature increases under certain MRI conditions not reflected in the Instructions for Use. Healthcare facilities and patients should stop using the devices immediately and follow the厂

I.T.S. GmbH
Updated MRI
Read more
Health & Personal Care
HIGH
FDA DRUG

Dukal BZK Antiseptic Towelettes Recalled for CGMP Deviations (2026)

Nationwide recall of Dukal BZK Antiseptic Towelettes due to CGMP deviations. The products are manufactured for Dukal, LLC in Ronkonkoma, NY and distributed across the United States. Stop using immediately and contact ACME United Corporation for guidance.

Dukal
CGMP Deviations
Read more
Health & Personal Care
HIGH
FDA DEVICE

Instrumentation Laboratory Recalls GEM Premier 5000 GEM PAK Cartridges Over PCSND Errors, 1,989 US/3

GEM Premier 5000 recall announced for 1,989 units distributed worldwide, including the US and numerous other countries. The issue involves GEM PAK cartridges experiencing Process Control Solution Not Detected errors during warm-up, causing ejections and potential delays in patient results. Stop using the device and follow manufacturer recall instructions.

Instrumentation Laboratory
Confirmed customer
Read more
Health & Personal Care
HIGH
FDA DRUG

Medi-First Antiseptic Wipes Recalled for CGMP Deviations in 2026, 100 Wipes per Box

ACME United Corporation recalled Medi-First Antiseptic Wipes sold nationwide in the United States. The recall cites CGMP deviations that could affect product quality. Consumers and healthcare providers should stop using the wipes immediately and contact ACME United Corporation or a healthcare provider for guidance.

Medi-First Antiseptic Wipes
CGMP Deviations
Read more
Health & Personal Care
HIGH
FDA DEVICE

Integra LifeSciences Recalls Medical Dressing Due to Sterility Risk

Integra LifeSciences Corp. recalled 55,276 units of MEDIHONEY Calcium Alginate with Active Leptospermum Honey on January 16, 2026. The recall cites potential packaging failures that may compromise sterility. Affected products include model numbers 31012, 31022, and 31045.

Integra LifeSciences Corp.
Potential packaging
Read more
    burn risk Recalls | RecallRadar