infant product Recalls

794 recalls tagged with “infant product”.

Health & Personal Care
HIGH
FDA DRUG

Baxter Acetaminophen Injection 1000 mg/100 mL Recall for Discoloration

Baxter Healthcare’s Acetaminophen Injection 1000 mg/100 mL is recalled. The nationwide recall covers 13,000 containers with lot 24A27G66 and expiring 12/31/2025. The FDA lists discoloration as the hazard. Stop using and contact Baxter or a healthcare provider.

Baxter Healthcare Corporation
Discoloration
Read more
Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Pacemakers Recalled in Class I High-Hazard Software Issue Affecting ACCOLADE, VERS

Boston Scientific recalled 7,488 pacemakers worldwide due to software that could impair Safety Mode initiation in high-battery-impedance states. Devices include ACCOLADE family models and CRT-Ps such as VISIONIST and VALITUDE. The issue stems from software designed to enhance Safety Architecture. Patients should follow manufacturer instructions and contact providers immediately.

Boston Scientific
Software to
Read more
Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Pacemakers Recalled for Software Flaw That Could Block Safety Mode

Boston Scientific recalled 32,695 ACCOLADE family pacemakers and related CRT-Ps after discovering software that could prevent entering Safety Mode when battery impedance is high. The recall is worldwide and classified as Class I with a high hazard level. Patients should stop using the devices and follow manufacturer instructions. Contact Boston Scientific or a healthcare provider for guidance.

Boston Scientific
Software to
Read more
Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Pacemakers Recalled for Safety-Mode Initiation Software Flaw (2025)

Boston Scientific recalled 1,050 pacemaker units worldwide on Aug 20, 2025. The recall covers ACCOLADE family devices and Visionist and Valitude CRT-Ps. A software issue could prevent Safety Mode initiation in ambulatory settings. Patients should follow manufacturer guidance and contact their clinician immediately.

Boston Scientific
Software to
Read more
Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Pacemakers Recall 28,911 U128 ACCOLADE, VISIONIST VALITUDE CRT-P Devices (2025)

Boston Scientific recalled 28,911 pacemakers worldwide due to a software flaw in Safety Architecture that could prevent Safety Mode when battery impedance is high. The recall covers ACCOLADE family devices and VISIONIST and VALITUDE CRT-Ps. Patients should stop using the device immediately and follow the recall letter instructions.

Boston Scientific
Software to
Read more
Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Pacemaker L231 Recalled; 63,851 Units in 2025

Boston Scientific recalled 63,851 L231 pacemakers worldwide on August 20, 2025. The recall covers the ACCOLADE family and related devices, including PROPONENT, ESSENTIO, ALTRUA 2 DR SL/EL, and VISIONIST and VALITUDE CRT-Ps. The software flaw could prevent Safety Mode from initiating when needed. Stop using the device and contact your healthcare provider for instructions immediately.

Boston Scientific
Software to
Read more
Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Pacemaker Recall Affects 3,620 Units Worldwide in 2025

Boston Scientific recalls 3,620 pacemakers worldwide including VALITUDE CRT-P EL and ACCOLADE family devices. A software update is intended to prevent initiation of Safety Mode due to high battery impedance. Patients and clinicians should stop using affected devices and await manufacturer instructions.

Boston Scientific
Software to
Read more
Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Pacemakers Recalled for High Battery Impedance Safety Software

Boston Scientific recall affects 4,055 pacemakers worldwide. The recall covers ACCOLADE family devices, ALTRUA 2 DR SL/EL, VISIONIST and VALITUDE CRT-P models. Software intended to enhance Safety Architecture can fail to initiate Safety Mode in ambulatory settings. Patients should stop using the device and contact their clinician.

Boston Scientific
Software to
Read more
Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Pacemakers Recalled Over Software Flaw in Safety Architecture (2025)

Boston Scientific recalls 223,163 pacemakers worldwide due to software issues affecting Safety Architecture. The recall covers ACCOLADE, PROPONENT, ESSENTIO, ALTRUA 2 DR devices and VISIONIST and VALITUDE CRT-Ps. The defect prevents initiation of Safety Mode when battery impedance is high. Patients should stop using the device and follow manufacturer instructions.

Boston Scientific
Software to
Read more
Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific ESSENTIO DR EL MRI Pacemaker Recalled for Software Safety Issue (190,088 Units, 0)

Boston Scientific recalled 190,088 pacemakers worldwide, including ACCOLADE family devices and related CRT-Ps. The software to enhance Safety Architecture could prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state. Patients and healthcare providers should stop using these devices immediately and await manufacturer instructions by letter.

Boston Scientific
Software to
Read more
Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Pacemakers Recalled Over Software Issue in Safety Architecture (2025)

Boston Scientific recalled 3,146 pacemakers worldwide after identifying a software defect that could prevent Safety Mode initiation in an ambulatory setting. Devices include ACCOLADE family models and VISIONIST and VALITUDE CRT-Ps. Patients should stop using affected devices and follow manufacturer instructions.

Boston Scientific
Software to
Read more
Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific L221 PROPONENT DR EL Pacemaker Recalled for Safety Software Issue (2025)

Boston Scientific is recalling 3,592 pacemakers sold worldwide through hospitals and clinics in 2025. A software feature intended to enhance Safety Architecture may fail to initiate Safety Mode in ambulatory settings due to high battery impedance. Patients and healthcare providers should stop using these devices immediately and follow the recall instructions.

Boston Scientific
Software to
Read more
Health & Personal Care
HIGH
FDA DRUG

Lannett 10mg Dextroamphetamine Tablets Recalled for Foreign Tablet Contamination (2025)

Lannett Company Inc. recalls 4,848 bottles of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets. A bottle labeled 10 mg 100-count contained a 5 mg tablet. Two bottles were affected. Consumers and healthcare providers should stop using this product immediately. Contact Lannett or a healthcare provider for guidance.

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate
Presence of
Read more
Health & Personal Care
HIGH
FDA DRUG

Chlorpromazine Hydrochloride 200 mg Recall Expanded After Packaging Contamination Found in 3,363 JDS

Amneal Pharmaceuticals products containing chlorpromazine hydrochloride are recalled nationwide after the FDA-linked notice identifies a foreign substance in packaging material. No tablets were contaminated. The recall was issued August 18, 2025 and updated September 10, 2025. Consumers and healthcare providers should stop using the affected lots immediately and contact Amneal for guidance.

Chlorpromazine Hydrochloride
Presence of
Read more
Health & Personal Care
HIGH
FDA DRUG

B. Braun Lactated Ringers Injection 46,032 Containers Recalled Over Particulate Matter

B. Braun Medical recalled 46,032 containers of Lactated Ringers Injection USP sold nationwide in the United States. The recall cites the presence of particulate matter in the 1000 mL IV solution. Consumers should stop using the product immediately and contact their healthcare provider or B. Braun for guidance.

B Braun Medical
Presence of
Read more
Health & Personal Care
HIGH
FDA DEVICE

Corneat Vision EverPatch+ 180-Unit Recall for Scleral Patch Dehiscence Risk (2025)

CORNEAT VISION recalled 180 units of EverPatch+ scleral reinforcement patch worldwide after complaints of conjunctival wound dehiscence. The issue can lead to early exposure of the surgical patch. Clinicians and patients should stop using the device immediately and follow the manufacturer recall instructions.

CORNEAT VISION
Reviewed complaints
Read more