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 May 16, 2018

Fabius MRI, anesthesia machine, catalog no. 8607300 Product Usage: The products are inhalation anesthesia machines for…

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

Draeger Medical, Inc.

3 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported May 16, 2018

EasyTouch (ET) Insulin Syringe 29G 1ml ¿" (Item 829155) Product Usage: INTENDED FOR INJECTION OF U100 INSULIN ONLY

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

MHC Medical Products LLC

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported May 16, 2018

Lipase, Catalog number: LI3837; GTIN: 05055273204230 and Catalog number: LI8361; GTIN: 05055273214284 Product Usage:…

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

Randox Laboratories Ltd.

FDA (openFDA device enforcement)

Medical devices

Reported May 16, 2018

ADVIA Ammonia (AMM) chemistry assay, an in vitro diagnostic device intended to quantitatively measure Ammonia levels in…

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

Siemens Healthcare Diagnostics, Inc.

43 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported May 16, 2018

Straumann¿ Emdogain 0.15 ml 5-Pack. Enamel Matrix Derivative. Article Number 075.098W

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

Straumann Manufacturing, Inc.

5 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported May 16, 2018

AirLife Resuscitation, Adult, with mask, oxygen reservoir bag Product Usage: The AirLife Resuscitation devices are…

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

Vyaire Medical

34 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported May 9, 2018

StoneBreaker Pneumatic Lithotripter, Catalog number: SBL-KIT1; GPN: G52604 UDI:(01)00827002526044

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

Cook Inc.

6 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported May 9, 2018

PTS Panels¿ CHOL+GLU Test Strips (REF 1765)

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

Polymer Technology Systems, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported May 2, 2018

Evicel Accessory Device - 45 cm Flexible Tip (SET OF 3), Product Code EVT45. Accessory Tips for use only with EVICEL…

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

Ethicon, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported May 2, 2018

Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015

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

Smith & Nephew, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Apr 25, 2018

GE Healthcare Lunar: a) DPX Duo, Model Number: LU41693 b) DPX Bravo, Model Number: LU41692 Provides an estimate of BMD…

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

GE Medical Systems Ultrasound & Primary Care Diagnostics, LL

2 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Apr 25, 2018

Halyard Closed Suction System for Adults, Double Swivel Elbow (DSE). Used to aspirate liquids or semisolids from a…

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

Halyard Health, Inc.

2 more products in this recall

FDA (openFDA device enforcement)

Drugs

Reported Apr 25, 2018

Triamterene and Hydrochlorothiazide Tablets, USP, 75 mg/50 mg, 500-count bottles, Rx only, Manufactured by Sandoz,…

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

Sandoz Incorporated

FDA (openFDA drug enforcement)

Medical devices

Reported Apr 25, 2018

MEVATRON M2 / PRIMUS Mid-Energy, Digital Linear Accelerator, Model No. 01940035 Product Usage: The intended use of the…

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

Siemens Medical Solutions USA, Inc.

5 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Apr 18, 2018

AQUIOS CL Flow Cytometer System, Catalog #B30166. The AQUIOS CL Flow Cytometer system is an automated analyzer that use…

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

Beckman Coulter Inc.

2 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Apr 18, 2018

Hamilton-C2 Ventilator Unit Intended to provide ventilator support to adults and pediatrics and optionally infants and…

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

Hamilton Medical AG

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Apr 18, 2018

Hematology Diluent M-30D used with BC-3200 and BC-3600 Hematology Analyzer; Part Numbers: (1) 105-005405-00 (2 x 5.5L…

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

Mindray DS USA, Inc. dba Mindray North America

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Apr 18, 2018

D-RAD Self-Tapping Locking Screw intended for the fixation of fractures involving the distal radius. smith&nephew D-RAD…

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

Smith & Nephew, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Apr 11, 2018

Radial Artery Catheterization Kit; Model: AK-04018

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

Arrow International Inc.

9 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Apr 11, 2018

HydroSil Gripper Intermittent Catheters- 10" lengths - 30 catheters per box, each catheter is packaged in an individual…

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

C.R. Bard, Inc.

2 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Apr 4, 2018

(1) Sigma HP Cemented Trochlea Size 1 Narrow Left, Catalog Number: 102403100, GTIN: 10603295001614; (2) Sigma HP…

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

DePuy Orthopaedics, Inc.

FDA (openFDA device enforcement)

Medical devices

Reported Apr 4, 2018

ACUVUE OASYS Brand Contact Lenses with HYDRACLEAR PLUS

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

Johnson & Johnson Vision Care, Inc.

2 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Apr 4, 2018

EasyCAL HbA1c Calibrator; REF 10658 Kit is packaged in a paper box containing 4 vials of 0.25ml of calibrant, one for…

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

Medica Corporation

FDA (openFDA device enforcement)

Medical devices

Reported Apr 4, 2018

Gas Module 3 monitoring spirometer, Part Number: 115-030108-00 Product Usage: The Gas Module 3 is an accessory device…

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

Mindray DS USA, Inc. dba Mindray North America

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.