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 Nov 10, 2021

IPL Coupling Gel, I L (AX1009013), 12 pack of 0.25 L (AX1009018), 6 pack of 1 L (AX1009019 or AX1009063); and IPL…

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

Lumenis, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Nov 10, 2021

Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861

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

Siemens Healthcare Diagnostics, Inc.

1 more product in this recall

FDA (openFDA device enforcement)

Drugs

Reported Nov 3, 2021

Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454…

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

Lupin Pharmaceuticals Inc.

FDA (openFDA drug enforcement)

Medical devices

Reported Oct 27, 2021

Catalog # BEK4511, Qty: 10, Ecomomy Jamshidi Bone Marrow Biopsy and Aspiration Tray, 11 G X 4"Biopsy/Aspiration needle,…

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

Bard Peripheral Vascular Inc.

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Oct 27, 2021

SIGNA Premier nuclear magnetic resonance imaging system

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

GE Healthcare, LLC

9 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Oct 27, 2021

Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT…

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

Medtronic Xomed, Inc.

2 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Oct 20, 2021

BioPlex 2200 ANA Screen Control Set, REF: 663-1131 incompatible with ANA Screen Reagent Packs/ANA Kits, REF: 665-1150;…

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

Bio-Rad Laboratories, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Oct 20, 2021

Elekta Medical Linear Accelerator (EMLA), configured as follows: a. Elekta Precise Digital Accelerator; b. Elekta…

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

Elekta, Inc.

FDA (openFDA device enforcement)

Drugs

Reported Oct 20, 2021

Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection, 1 mg per vial; Diluent for Glucagon, 1 mL syringe.…

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

Eli Lilly & Company

FDA (openFDA drug enforcement)

Medical devices

Reported Oct 13, 2021

REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI:…

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

Bard Peripheral Vascular Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Oct 13, 2021

Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK

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

Beckman Coulter Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Oct 13, 2021

CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103

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

CardioQuip, LLC

4 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Oct 13, 2021

GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8.5OZ BOTTLES/4248, 5 LITER/4266, distributed by DJO, LLC / DJO…

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

Djo, LLC

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Oct 13, 2021

Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product Usage: use in the calibration of…

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

Sentinel CH SpA

FDA (openFDA device enforcement)

Medical devices

Reported Oct 13, 2021

ELI, Burdick and McKesson brand 280 Resting Electrocardiographs (ELI 280, MLBUR280 and BUR280), Model Numbers:…

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

Welch Allyn Inc. Mortara

FDA (openFDA device enforcement)

Medical devices

Reported Oct 6, 2021

Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusive Model: 086-330.

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

Biodex Medical Systems, Inc.

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Oct 6, 2021

The Instructions for Use (IFU) for: Gelsoft Plus Bifurcate, Gelsoft Plus Ax-Fem, GelsoftPlus ERS Ax-Fem, Gelweave…

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

Vascutek, Ltd.

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Sep 29, 2021

EcoGel 100 Imaging Gel, EcoGel 200 MultiPurpose Gel (Blue), EcoGel 200 MultiPurpose Gel (CLEAR), and EcoLotion…

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

AMTEC SALES Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Sep 29, 2021

Access SARS CoV-2 IgG (1st IS) Assay: Access Immunoassay Systems REAGENT PACK, REF C74339 Access SARS-CoV-2 IgG (1st…

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

Beckman Coulter Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Sep 29, 2021

Greiner Bio-One VACUETTE¿ TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube,…

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

Greiner Bio-One North America, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Sep 29, 2021

10 ga ARS Decompression Needle, Part Number ZZ-0298

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

North American Rescue LLC.

FDA (openFDA device enforcement)

Medical devices

Reported Sep 29, 2021

EPIQ Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: EPIQ 5 - 795120 EPIQ 5C - 795205…

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

Philips Ultrasound Inc.

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Sep 22, 2021

Alinity ci-series System Control Module clinical chemistry and immunoassay analyzer for in vitro diagnostic use. Model…

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

Abbott Laboratories

FDA (openFDA device enforcement)

Medical devices

Reported Sep 22, 2021

BD Extension Set SMALLBORE Tubing with 2 SmartSite VALVES, REF: 20019E

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

Carefusion

14 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.