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 Sep 22, 2021

Lyra Direct SARS-CoV-2 Assay Emergency Use Authorization- Ref: M124. The Lyra Direct SARS-CoV-2 Assay is a real-time…

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

Quidel Corporation

FDA (openFDA device enforcement)

Medical devices

Reported Sep 22, 2021

ACUSON Juniper Diagnostic Ultrasound System

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 Sep 22, 2021

Braun ThermoScan PRO 6000 Ear Thermometer-indicated for the intermittent measurement of human body temperature for…

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

Welch Allyn Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Sep 15, 2021

COPAN FLOQSwabs, STERILE.EO, for drawing clinical samples. CE0123, for the following reference numbers REF:501CS01,…

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

Copan Italia

FDA (openFDA device enforcement)

Medical devices

Reported Sep 15, 2021

Pipeline Flex Embolization Device

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

Micro Therapeutics Inc.,

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Sep 15, 2021

Ingenia 1.5T- a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can…

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

Philips North America LLC

12 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Sep 15, 2021

NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129

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

Smiths Medical ASD Inc.

1 more product in this recall

FDA (openFDA device enforcement)

Drugs

Reported Sep 8, 2021

Artificial Tears Ointment, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube, Sterile, Manufactured by: Akorn,…

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

Akorn, Inc.

FDA (openFDA drug enforcement)

Medical devices

Reported Sep 8, 2021

CoolSculpting Elite System The CoolSculpting System SW release 2.0, SW release 3.0, SW release 3.0.1, SW release 3.0.2

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

Zeltiq Aesthetics, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Sep 1, 2021

AltiVate Anatomic Shoulder System for the following Part Numbers: 1. Part # 520-08-00, Rev. C., 2. Part # 520-10-000,…

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

Encore Medical, LP

FDA (openFDA device enforcement)

Medical devices

Reported Sep 1, 2021

HARMONIC HD 1000i Shears (20cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal…

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

Ethicon Endo-Surgery Inc.

1 more product in this recall

FDA (openFDA device enforcement)

Drugs

Reported Aug 25, 2021

Avicel, Mirocrystalline cellulose, packaged in bulk as PH101 NF, PH102 NF, PH200 NF, Manufactured by: DuPont Nutrition…

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

DuPont Nutrition USA, Inc.

FDA (openFDA drug enforcement)

Medical devices

Reported Aug 25, 2021

OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004

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

OPTI Medical Systems, Inc.

FDA (openFDA device enforcement)

Drugs

Reported Aug 25, 2021

DAUNOrubicin Hydrochloride Injection 20 mg/4mL, 4mL Single Dose vials, 10 in 1 carton, Rx only, Teva Parenteral…

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

Teva Pharmaceuticals USA

18 more products in this recall

FDA (openFDA drug enforcement)

Medical devices

Reported Aug 18, 2021

Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. for the controlled administration of…

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

Baxter Healthcare Corporation

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Aug 18, 2021

ACCESS SARS-CoV-2 Antigen , REF: C68668, IVD, Rx only, UDI: (01) 15099590742713;

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

Beckman Coulter Inc.

3 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Aug 18, 2021

Chassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX - "CIRRUS HD-OCT Model 6000"

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

Carl Zeiss Meditec, Inc.

FDA (openFDA device enforcement)

Drugs

Reported Aug 18, 2021

BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 40MG-4000MCG/ML, 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281…

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

Med Shop Total Care Inc.

13 more products in this recall

FDA (openFDA drug enforcement)

Medical devices

Reported Aug 11, 2021

REF: 08P1820, Abbott Alinity c Activated Alanine Aminotransferase reagent Kit, Alinity c Activated Alanine…

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

Abbott Laboratories

3 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Aug 11, 2021

Beta-Hydroxybutyrate LiquiColor. in vitro diagnostic reagent.

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

Stanbio Laboratory, LP

4 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Aug 11, 2021

GlideScope Go Monitors

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

Verathon, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Aug 4, 2021

ThermoScientific Oxoid Antimicrobial Susceptibility Discs Rx only Made in the United Kingdom

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

Remel Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Aug 4, 2021

Zippie Voyage, early intervention stroller - Product Usage: is manually operated by a caregiver for purposes of…

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

Sunrise Medical (US) LLC

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Jul 28, 2021

Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. 86022. Used to cool or warm blood during…

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

Gentherm Medical, LLC

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.