🔍 RecallPedia

All Recalls

95,114 total recalls in our database

🍎
28,983
Food
 💊
17,685
Drugs
 🏥
38,779
Medical Devices
 🏠
9,667
Consumer Products

Exotic Superfoods 100% Raw Young Thai Coconut Water, 32 oz. SKU: 7 05105 50171 0 Exotic Superfoods 100% Raw Young Thai Coconut Water, 11.7 oz. SKU: 7 05105 50161 1 Description of the Product: - 32 oz (1 quart): - The product is consumed in individual clear plastic bottles. - Each bottle has a white label. - There are 12 bottles in a case. - 11.7 oz: - The product is sold in individual clear plastic bottles. - Each bottle has a white label. - There are 12 bottles in a case Product of Thailand Distributed by Exotic Superfoods www.exoticsuperfoods.com NY e-mail: info@exoticsuperfoods.com CA e-mail: caliinfo@exoticsuperfoods.com

Exotic Superfoods New York

🍎 Food Class I - Dangerous

It appears that these batches were not subjected to 5-log reduction as part of their processing.

Oct 24, 2014 Beverages View Details →

Assured Naproxen Sodium Tablets, USP 220 mg., 15 count bottle, Repackaged by Contract Packaging Resources, Inc 8009 Industrial Village Road Greensboro, NC 27409 Distributed by Greenbrier International, Inc Chesapeake, VA 23320

Contract Packaging Resources

💊 Drugs Class I - Dangerous

Correct Labeled Product Mispacked; correct labeled bottles of Assured Ibuprofen softgels were packaged into cartons of Assured Naproxen Sodium Tablets, USP

Oct 10, 2014 Prescription Drugs Nationwide View Details →

FLUOCINONIDE GEL USP, 0.05%, Rx only, For External Use Only, Not For Ophthalmic Use, a) NET WT 15 gram tubes and b) NET WT 60 grams tubes, E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0135-15 (15 g) and NDC 0168-0135-60 (60 g)

Fougera Pharmaceuticals

💊 Drugs Class I - Dangerous

Failed Stability Specifications: The lots of Fluocinonide Gel USP, 0.05% recalled, may not meet the requirements for residual solvents as outlined in USP <467>.

Aug 28, 2014 Prescription Drugs Nationwide View Details →

AMS 700 Series Inflatable Penile Prosthesis Accessory Kit (AMS 700 Line Accessory Kit), 72401850. Keith Needles are part of the AMS 700 Accessory Kit. In conjunction with the Furlow Insertion Tool (Furlow), the Keith Needles facilitate the passing of the pulling sutures through the glans to place the AM3-700 cylinders in the corpus cavernosa.

American Medical Systems

🏥 Medical Devices Class I - Dangerous

AMS' supplier has issued a recall of certain lots of Lightning Bolt Keith needles supplied in AMS 700 Accessory Kits. Based on this, AMS is recalling AMS 700 Accessory Kits which contain these lots of needles. The supplier made the decision to issue this recall after an internal investigation that was requested by AMS. The investigation identified a potential nonconformity that may lead to a bent or broken Keith Needle when used with the Furlow tool.

Oct 10, 2014 Surgical Instruments Nationwide View Details →

Discovery NM 630, dual detector free-geometry integrated nuclear imaging system. Models H3100RC, H3100RD, H2401LW. Product Usage: The GE Discovery NM 630 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and in assessment of organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy. The GE Discovery NM 630 system is a Nuclear Medicine (NM) system, which is intended to yield General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The scanning modes include planar mode (Static, Multi-gated, Dynamic and Whole body scanning) and tomographic mode (SPECT, Gated SPECT, Whole body SPECT). The acquisition types include single and multi-isotope/ multi peak frame/list mode single-photon imaging. The imaging-enhancement features include assortment of collimators, gating by physiological signals, and real-time automatic body contouring. The GE Discovery NM 630 system may include signal analysis and display equipment, patient and equipment supports, components and accessories. The system may be used for patients of all ages.

GE Healthcare

🏥 Medical Devices Class I - Dangerous

GE is updating the Preventative Maintenance procedure and schedule, and added an additional Preventative Maintenance check for loose fasteners on the Nuclear Medicaine systems. This check is being added to prevent a portion of the system falling onto the patient during a scan due to fasteners being loose that secure the camera to the gantry.

Oct 14, 2014 Diagnostic Equipment Nationwide View Details →

MX 16-slice CT Scanner System and MX 16-slice CT Scanner System Phase 11 can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from the same axial plane taken at different angles. The system is suitable for all patients. Access Dual CT system can be used as a Head and Whole Body Computed Tomography X-ray System featuring a continuously rotating X-ray tube and detector array with multi-slice capability. The acquired X-ray transmission data is reconstructed by computer into cross-sectional images of the body from the same axial plane taken at different angles.

Philips Medical Systems (Cleveland)

🏥 Medical Devices Class I - Dangerous

&quot;The orientation of images is displayed incorrectly. When operator chooses gantry on the right side from operation console, and the patient position is HFDL, HFDR, FFDL or FFDR, the patient position picture and text is not consistent. &quot;L&quot; and &quot;R&quot; of scan images are reversed and this is not consistent with the patient actual position. &quot;When a surview which is longe

Oct 9, 2014 Diagnostic Equipment View Details →

CooperSurgical MILEX PESSARY KITS- Hodge w/Support Folding Pessary- #1 Model: MXKPHS01 Product Usage: The CooperSurgical Milex silicon pessary is a safe and effective device used to manage a number of gynecologic issues including pelvic support defects and stress urinary incontinence. This treatment option is a non-invasive method assessing or resolving pelvic organ prolapse and stress incontinence issues

CooperSurgical

🏥 Medical Devices Class I - Dangerous

Incorrect expiration date printed on the MILEX PESSARY KIT packaging

Sep 30, 2014 Surgical Instruments View Details →

Fisher and Paykel Healthcare (FPH) IW900-Series Infant Warmer Fisher and Paykel; Healthcare CosyCot and Kit Replacement Head Case Assembly It is designed to assist with the thermoregulation of infants weighing up to 10kg and is used by labor and delivery rooms and pediatric intensive care units. Infant Warmers Model Number (REF) IW910XXX, IW920XXX, IW931XXX, IW932XXX, IW933XXX, IW934XXX, IW951XXX, IW952XXX, IW953XXX, IW954XXX, IW980XXX, IW990XXX Spare Parts Model Number (REF) 043041129, 043041130, 043041131, 043042359, 648040142

Fisher & Paykel Healthcare

🏥 Medical Devices Class I - Dangerous

Breakage of the nut that secures the heater head in place, which can cause the heater head to become partially detached and swing towards the bassinet. There is the potential that a heater head could contact a patient situated on the bassinet and cause a serious injury.

Nov 6, 2014 Infusion Pumps Nationwide View Details →

Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system. Models H3100NA, H3100PP, H3100RA, H2401LS, H2401LZ, H2402LS. Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy.

GE Healthcare

🏥 Medical Devices Class I - Dangerous

GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to the gantry. GE is updating the Preventative Maintenance procedure and schedule, and added an additional Preventative Maintenance check for loose fasteners on the Nuclear Medicaine systems.

Oct 14, 2014 Diagnostic Equipment Nationwide View Details →

Persona Stemmed 5 Degree Cemented Tibia Product Usage: This device is indicated for patients with severe knee pain and disability due to:  Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.  Collagen disorders, and/or avascular necrosis of the femoral condyle.  Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.  Moderate valgus, varus, or flexion deformities.  The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.  This device is intended for cemented use only.

Zimmer

🏥 Medical Devices Class I - Dangerous

Cleaning process validation failure.

Oct 9, 2014 Implants & Prosthetics Nationwide View Details →