All recall categories

Recalls distributed in Puerto Rico

These notices name Puerto Rico in the distribution list the company gave its agency. That list says where the product was shipped, not where it ended up — a recalled item can travel with a shopper, and some notices list no states at all.

2,528 stored notices name Puerto Rico, reported between Jun 20, 2012 and Sep 23, 2026. A further 48,100 notices were distributed nationwide, so they reach Puerto Rico too — those are in the archive.

Medical devices

Reported Oct 24, 2018

Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Mindray DS USA, Inc. dba Mindray North America

FDA (openFDA device enforcement)

Medical devices

Reported Oct 24, 2018

Terumo¿ Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Terumo Cardiovascular Systems Corporation

FDA (openFDA device enforcement)

Medical devices

Reported Oct 17, 2018

Enterprise Imaging Desktops Enterprise Imaging Desktops (Radiology Suite/Cardiology Suite) when deployed as a…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Agfa Healthcare NV

FDA (openFDA device enforcement)

Drugs

Reported Oct 17, 2018

Prevacid 24HR (Lansoprazole) delayed-release capsules, 15 mg, 14 capsules per bottle in a carton containing 1 bottle…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Glaxosmithkline Nebraska

FDA (openFDA drug enforcement)

Drugs

Reported Oct 17, 2018

Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle, Rx only, Manufactured by: Jubilant Generics…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Jubilant Cadista Pharmaceuticals, Inc.

FDA (openFDA drug enforcement)

Medical devices

Reported Oct 17, 2018

NeoMed Enteral Feeding Tubes with Enteral Only Connectors, French sizes 4.0Fr, 5.0Fr, 6.5Fr, 8.0Fr, and lengths 40cm,…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Neomed Inc.

FDA (openFDA device enforcement)

Drugs

Reported Oct 17, 2018

Actoplus met XR (pioglitazone and metformin HCl, extended-release) tablets, 15 mg/1000 mg, Rx Only, 30 tablet bottle,…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Takeda Development Center Americas, Inc.

FDA (openFDA drug enforcement)

Medical devices

Reported Oct 10, 2018

ENDOLOGIX AFX Endovascular AAA System, Stent Graft System, Rx Only, Sterile EO, REF: BA22-120/I20-40, BA22-100/I20-40,…

High riskUsing this product could cause serious injury, illness or death — stop using it now.

Endologix

3 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Oct 10, 2018

OptiMedica Catalys Precision Laser System, CE 0044 containing software cOS 5.00.33 Product Label for Serial Numbers:…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Johnson & Johnson Surgical Vision Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Oct 10, 2018

CAPNOSTREAM 20 (US) N, Part Number CS08651

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Oridion Medical 1987 Ltd.

36 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Oct 10, 2018

Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215,…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Smith & Nephew, Inc.

2 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Oct 10, 2018

TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Varian Medical Systems

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Oct 10, 2018

Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only. The AlignRT is a video-based…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Vision RT Ltd.

FDA (openFDA device enforcement)

Drugs

Reported Oct 3, 2018

Levofloxacin Injection in 5% Dextrose, 5 mg/mL, packaged in a) 50 mL (NDC 36000-046-24), b) 100 mL (NDC 36000-047-24),…

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

Baxter Healthcare Corporation

FDA (openFDA drug enforcement)

Medical devices

Reported Oct 3, 2018

ESSENTIO Pacemaker

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Boston Scientific Corporation

5 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Oct 3, 2018

INTEGRIS Allura 9, System Code 722018 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Philips Electronics North America Corporation

26 more products in this recall

FDA (openFDA device enforcement)

Drugs

Reported Sep 19, 2018

Hydrochlorothiazide Tablets USP, 12.5 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham,…

High riskUsing this product could cause serious injury, illness or death — stop using it now.

Accord Healthcare, Inc.

FDA (openFDA drug enforcement)

Medical devices

Reported Sep 19, 2018

da Vinci S/Si EndoWrist 8mm Monopolar Curved Scissors Model No. 420179-16 Product Usage: EndoWrist Instruments,…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Intuitive Surgical, Inc.

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Sep 19, 2018

Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 280 mm, Item Number: 814309280

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Zimmer Biomet, Inc.

128 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Sep 12, 2018

GE LOGIQ E9 ultrasound system Product Usage: The device is intended for use by a qualified physician for ultrasound…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

GE Medical Systems Ultrasound & Primary Care Diagnostics, LL

7 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Sep 5, 2018

Sysmex XN-Series Fluorocell PLT, Catalog #CD994563. Distributed in the U.S.A. by Sysmex America, Inc., Lincolnshire,…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Sysmex America, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Aug 29, 2018

bioMerieux VITEK 2 Gram Positive Cefoxitin Screen, VITEK 2 Gram Positive AST for Oxacillin, VITEK SYSTEMS General…

High riskUsing this product could cause serious injury, illness or death — stop using it now.

bioMerieux, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Aug 29, 2018

ELEKTA Digital Accelerator under the following brand names: Elekta Synergy, Synergy S, Synergy Platform, Precise…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Elekta, Inc.

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Aug 29, 2018

GE Healthcare Revolution EVO, Optima CT660, Optima CT670, Optima CT680. The systems are intended for head, whole body,…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

GE Healthcare Japan Corporation

3 more products in this recall

FDA (openFDA device enforcement)

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Other states

RecallNow is not a government agency. Every notice above was published by the FDA, USDA FSIS or CPSC and links back to its source. Browse the whole archive.