fda regulated Recalls

689 recalls tagged with “fda regulated”.

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 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

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

I.T.S. Pelvic Reconstruction System Recall for MRI Heating Risk (46,637 Units) 2026

I.T.S. recalled 46,637 pelvic reconstruction system components nationwide in the United States after MRI safety testing showed higher RF-induced heating than the IFU stated. The issue centers on MRI heating under certain conditions that could injure patients. Patients should stop using the devices and follow manufacturer recall instructions.

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

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. 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

STAAR Surgical AG EVO+ Visian TICL VTICM5 Recalled for 12.6 mm Length Mismatch (2026)

STAAR Surgical AG recalled 7 EVO+ Visian TICL VTICM5 lenses after finding a labeling error that listed 12.1 mm length but which are 12.6 mm. The mismatch can cause excessive vault and ocular complications. Physicians and patients should stop using the device immediately and follow manufacturer instructions for recall actions.

STAAR Surgical AG
Toric Implantable
Read more
Health & Personal Care
HIGH
FDA DEVICE

Agiliti Recalls Adapt Pump Over Microclimate Management Failure

Agiliti Health recalled 4,286 Adapt Pumps on January 21, 2026, after identifying a malfunction. The issue prevents the Microclimate Management function from re-engaging following the Autofirm function. This defect poses a risk to patients relying on the device for safe pressure management.

Agiliti Health - Ellis
Agiliti identified
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 DRUG

ACME United BZK Antiseptic Towelettes Recall for CGMP Deviations (2026)

ACME United Corporation recalled BZK Antiseptic Towelettes sold for Food Service Resources nationwide after CGMP deviations were found. The recall is Class II and high risk. Consumers and healthcare providers should stop using this product immediately and follow recall guidance.

ACME United
CGMP Deviations
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 DRUG

Med-Nap Cleansing Towelettes Recall 2026 for CGMP Deviations

Med-Nap Cleansing Towelettes, manufactured by Acme United Corporation, were recalled nationwide on January 20, 2026. The recall cites CGMP deviations in manufacturing for benzalkonium chloride 0.13% towelettes. Consumers and healthcare providers should stop using the product immediately and contact Acme United for guidance.

Med-Nap Cleansing Towelettes
CGMP Deviations
Read more
Health & Personal Care
HIGH
FDA DRUG

ACME United's First Aid Only BZK Towelettes Recall 2026: CGMP Deviations Prompt Nationwide Action

ACME United Corporation recalled First Aid Only BZK Antiseptic Towelettes nationwide after CGMP deviations were identified in manufacturing. The products carry NDC 0924-7116-03 and come in 50-wipe packages. Consumers should stop using the product and contact the company for guidance. A recall notice will be mailed to affected customers.

First Aid Only
CGMP Deviations
Read more
Health & Personal Care
HIGH
FDA DRUG

First Aid Only BZK Antiseptic Towelettes Recall for CGMP Deviations (2026)

First Aid Only BZK Antiseptic Towelettes are recalled nationwide in 2026 after CGMP Deviations were identified at the Acme United Corporation facility. The recall cites CGMP Deviations that could affect product quality. Consumers should stop using the product and contact Acme United Corporation for guidance.

First Aid Only BZK Antiseptic
CGMP Deviations
Read more
Health & Personal Care
HIGH
FDA DRUG

Acme United MED NAP BZK Antiseptic Towelettes Recalled in 2026 (100-Count)

Acme United Corporation recalled Med Nap BZK Antiseptic Towelettes, 100-count, distributed nationwide. The FDA-listed CGMP deviations raise concerns about manufacturing quality and product safety. Consumers and healthcare providers should stop using the product and follow the recall letter for guidance.

Acme United Corporation
CGMP Deviations
Read more
Health & Personal Care
HIGH
FDA DRUG

ACME UNITED Recalls Max Packaging Antibacterial Towelette for CGMP Deviations (2026)

ACME UNITED recalled Max Packaging Antibacterial Towelette nationwide in the United States after CGMP deviations were identified. Manufacturing quality deviations prompted the recall, classified as Class II and labeled as high hazard. Stop using the product immediately and contact ACME UNITED CORPORATION or your healthcare provider for guidance.

ACME UNITED
CGMP Deviations
Read more
Previous
12345...35
Next

Tag Statistics

Total Recalls
689

Related Tags

burn riskelectrical hazardcpsc regulatedimmediate actionstop use immediatelyreturn for refundelectronicmetalreplacement availableworkplacemandatory standard violationadult product