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 48,122 notices were distributed nationwide, so they reach Puerto Rico too — those are in the archive.

Drugs

Reported Dec 17, 2014

GENTAMICIN INJECTION, USP, equivalent to 40 mg/mL, Rx only, 20 mL Multiple Dose Vial, Manufactured by APP…

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

Fresenius Kabi USA, LLC

3 more products in this recall

FDA (openFDA drug enforcement)

Medical devices

Reported Dec 17, 2014

Medtronic MiniMed Silhouette and/or MiniMed Sure-T Infusion Sets; Paradigm Silhouette infusion sets: MMT-368,…

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

Medtronic MiniMed Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Dec 17, 2014

BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an…

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

Philips Medical Systems, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Dec 17, 2014

Align Radial Stems, Prosthesis, Elbow, Hemi Replacement of the radial head for degenerative or post-traumatic…

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

Skeletal Dynamics

FDA (openFDA device enforcement)

Medical devices

Reported Dec 10, 2014

Amerigel Hydrogel Wound Dressing Wound management

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

Amerx Health Care Corp.

3 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Dec 10, 2014

ADULT Radiotransparent Electrode, REF/Catalog Number 2001H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART…

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

ConMed Corporation

8 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Dec 10, 2014

Surgical packs (includes trays, bags and kits) Used by medical staff to perform patient care procedures such as wound…

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

Customed, Inc.

178 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Dec 10, 2014

Polyflux Revaclear Dialyzer, Model Number 110633. The Polyflux Revaclear¿ and Polyflux Revaclear¿ Max Dialyzers are…

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

Gambro Renal Products Inc.

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Dec 10, 2014

MAS CardioImmune XL Cardiac Marker Control; Model: CAI-XL1; intended for use in the clinical laboratory as an assayed…

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

Microgenics Corporation

FDA (openFDA device enforcement)

Medical devices

Reported Dec 10, 2014

The Artis zee / zeego Angiography System is designed as a set of components that may be combined into different…

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

Siemens Medical Solutions USA, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Dec 10, 2014

Aquapak Adaptor, 028 NEB, INTL, Product No. 403128; Aquapak Adaptor, 033 NEB, INTL, Product No. 403133; Aqaupak…

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

Teleflex Medical

1 more product in this recall

FDA (openFDA device enforcement)

Drugs

Reported Dec 10, 2014

BENZONATATE Capsules, USP, 200 mg, 100 Capsule Bottles, Rx only. Manufactured by: Cadila Healthcare Ltd, Ahmedabad,…

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

Zydus Pharmaceuticals USA Inc.

FDA (openFDA drug enforcement)

Medical devices

Reported Dec 3, 2014

ARCHITECT Total T3 Reagent Kit (7K64) consists of: - 1 or 4 Bottle(s) (6.6 mL/27.0 mL) anti-T3 (sheep) coated…

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

Abbott Ireland Diagnostics Division

FDA (openFDA device enforcement)

Drugs

Reported Dec 3, 2014

Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only. Manufactured by:…

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

Actavis Laboratories, FL, Inc.

FDA (openFDA drug enforcement)

Medical devices

Reported Dec 3, 2014

Dharma Cavity Varnish with Fluoride

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

Dharma Research, Inc.

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Dec 3, 2014

LUNA Chest, Model No. LU4006

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

Novadaq Technologies, Inc.

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Dec 3, 2014

Trabecular Metal Tibial Impactor. Product Usage: TM Tibial Impactor pads are used in conjunction with the TM Tibial…

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

Zimmer, Inc.

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Nov 26, 2014

Edwards Lifesciences Vent Catheters, . Packaged sterile and non-pyrogenic in a sealed, peel-type pouch. Model Numbers:…

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

Edwards Lifesciences, LLC

FDA (openFDA device enforcement)

Medical devices

Reported Nov 19, 2014

AMS 700 Series Inflatable Penile Prosthesis Accessory Kit (AMS 700 Line Accessory Kit), 72401850. Keith Needles are…

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

American Medical Systems, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Nov 19, 2014

ATTUNE Intuition Distal Femoral Jig; sold non-sterile; product is wrapped in bubble wrap and then sealed inside a…

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

DePuy Orthopaedics, Inc.

FDA (openFDA device enforcement)

Drugs

Reported Nov 19, 2014

FLUOCINONIDE GEL USP, 0.05%, Rx only, For External Use Only, Not For Ophthalmic Use, a) NET WT 15 gram tubes and b) NET…

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

Fougera Pharmaceuticals Inc.

FDA (openFDA drug enforcement)

Drugs

Reported Nov 19, 2014

HALOPERIDOL DECANOATE INJECTION, 50 mg/mL, 1 mL vial, Rx only, Fresenius Kabi USA, LLC, Schaumburg, IL 60173 NDC…

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

Fresenius Kabi USA LLC

FDA (openFDA drug enforcement)

Medical devices

Reported Nov 19, 2014

GE Healthcare Infinia (including Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye, Infinia II Hawkeye 4,…

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

GE Healthcare, LLC

5 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Nov 19, 2014

Masimo SET uSpO2 Cable The Masimo SET uSpO2 Pulse Oximetry Cable is an in-line cable that provides continuous…

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

Masimo Corporation

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.