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.
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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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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.