2021 Product Recalls
4,623 recalls issued in 2021.
Showing 4561–4580 of 4,623 recalls
PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride, (100 mcg/mL) Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081012
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Ketamine 50 mg/5mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004043009
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
OUR SPECIALTY; Cake Truffles; Variety; Chocolate; Cookies 'N Creme; NO: Artificial Colors, Flavors, or High Fructose Corn Syrup; Net Wt. 19.5 oz(1 LB 3.5 oz) (552 g)
Product contains undeclared wheat.
Valanga Gourmet brand Snickerdoodle Cookie with cinnamon sugar on the outside. Each cookie is wrapped and sold individually. Expected shelf life 6 months frozen and 2 months refrigerated. Net wt. 4.4 oz (124g). UPC 814524616004. The Snickerdoodle Cookie label is read in parts: "***Ingredients: Flour (Wheat Flour, Malted Barley Flour Niacin, Iron (Reduced) Thiamine Mononitrate Riboflavin Folic Acid), Sugar, Margarine (Palm and Soybean Oil, Water, Salt, Soy Lecithin, Vegetable Mono & Diglyce
The firm declares whey as the margarine's sub-ingredient but does not declare milk.
HRV Carrot.Cubes 1/20LB/HRV DCD Cartos 1/20LB - bag in box product in a corrugated case; IQF Cartotte Cubes 3/8" 1/25LB/IQF Diced Cartos 3/8" 1/25LB - bag in box product in corrugated case; Classic Carot Cubes 12/2LB/Classic DCD Carrots 12/2LB - corrugated cases of 12 individual printed poly bags
Products may contain metal fragments (foreign objects).
Party Tray Vegetables with Ranch Dip, packaged in 40 oz (2.5 LBS) plastic tray with lid, UPC 3825911509.
The product has been recalled due to undeclared (allergen) egg.
GE Mixed Veg (4) 12/32oz/GE Mixed Veg (4) 12/32oz - packed in corrugated cases of 12 individual printed poly bags
Products may contain metal fragments (foreign objects).
HRV Carot.&Pois 1/20LB/HRV Carrot & Peas 1/20LB - bag in box product in corrugated case
Products may contain metal fragments (foreign objects).
OptiMedica Catalys Precision Laser System, CE 0044 containing software cOS 5.00.33 Product Label for Serial Numbers: 44109015; 44106215; 44107315; and 44065613 label states "Manufactured for: OptiMedica Corporation 1310 Moffett Park Drive Sunnyvale, CA 94089 USA Product Label for Serial Numbers: 46120916; 46123116, 46124617; 46131418, and 46131618 label states "Manufactured for: OptiMedica Corporation 510 Cottonwood Drive Milpitas, CA 95035 USA The Catalys Precision Laser System is indicat
Software upgrade exhibits failures when executing Daily Alignment Verification (DAV), specifically, cuts on the plastic hemisphere during DAV do not match the intended cuts shown on the treatment overlay screen on the system GUI.
On May 9, 2018, affected customers in the U.S. and Puerto Rico were contacted by phone and verbally informed to stop using the affected system. On May 22, 2018, the firm, Johnson & Johnson Vision, sent an "URGENT MEDICAL DEVICE FIELD REMOVAL" letter dated May 18, 2018 via Federal Express overnight delivery with signature required to all customers with a system containing the affected software installed. The customers were instructed to: STOP Using the affected system and complete and return the Customer Reply Form via fax to: Johnson & Johnson Vision Quality Assurance at 1-714-247-4510, emailed to RegComplione@its.jnj.com, or provide to your Johnson & Johnson Vision Representative within 3 business days of receipt of the letter. The firm will coordinate the removal of the affected software for all affected systems. All impacted customers will be provided with the new/updated software version. If you have any questions, contact the Director, Quality Assurance at 408-273-4100 or email: creyes51@its.jnj.com.
Campylobacter Blood Free Selective Medium, PN 7527A Used with cefoperazone for the selective isolation of Campylobacter spp. In a laboratory setting. Not intended for use in the diagnosis of disease or other conditions in humans.
The product is labeled with an incorrect expiration date.
The firm, Neogen, sent a "Product Notification" letter dated 8/2/2018 to customers on 8/2/2018. The letter described the product, problem and actions to be taken. The customers were instructed to amend the dating on the labeling accordingly and include the notification with the bottle(s). If you have any questions, contact the Senior Director of Quality Systems at 800-234-5333 Ext3230 or email: mratliff@neogen.com.
GE NM/CT 850 system Model Number H3907AD - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.
GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.
The firm initiated their action by letter to the consignees on 12/10/2020. The letter explained the issue and stated that GE would inspect, and if required, correct the affected units. Questions and concerns may be directed to GE Healthcare Service at 1-800-437-1171 or the consignee's local Service Representative.
Coonrad/Morrey Total Elbow Humeral Assembly, Extra Small, 4-inch Length. Model No. 32-8105-027-04. UDI (01)00889024274006 (17)241031(10)64481139 The device is a Humeral component; elbow joint metal/polymer constrained cemented prosthesis.
The lot contained two outer pins instead of one outer and one inner pin.
On December 12, 2019, the firm distributed Urgent Medical Device Recall letters to affected customers. The letter alerted customers that the product was potentially packaged with two outer pins and zero inner pins. Customer responsibilities: 1. Review the notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. Complete the included Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form will be returned even if you do not have affected products at your facility. 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. 5. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com
Arrow PICC powered by Arrow VPS Stylet Product Code: ASK45041JHVA
Lidstock states the incorrect expiration date for the product
Arrow International initiated recall by letter dated April 23,2019 described the problem, health risk and action to take: If you have affected stock in inventory, immediately discontinue use and quarantine the products. 2. Complete the enclosed Acknowledgement Form indicating whether you do or do not have stock and fax it to 1-855-419-8507 or email to recalls@teleflex.com. A customer service representative will contact you with a Return Goods Authorization (RGA) number and provide instructions for the return of products. Distributors requested to subrecall. Questions, contact your local sales representative or Customer Service at 1-866-396-2111.
VAMPIRO V5001-minimally invasive poole suction sleeve that is an accessory instrument to ANY 5mm spot suction/irrigation catheter
Lack of package integrity may compromise sterility
Santanello Surgical issued recall letter dated 6/10/19 stating reason for recall, health risk and action to take: immediately examine inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. Email contact@vampirosuction.com for return shipment procedures and reimbursement process. Questions call Santanello Surgical at 614-955-1832.
9" French Silk Base, Item 7545, Count per case 6 Ea., Case Weight 12 lb. 3 oz. UPC 50796220075458. Keep Frozen.
Undeclared Pecan
Backroad Country Spicy Cajun Mix 9 oz (255g) plastic bag. Packed by Troyer Manufacturing Millersburg, OH 44654.
Undeclared Allergens: Milk
Wireless Controller Sleep Mode Disabled
Inability to use the wireless remote controller may hinder the firefighting efforts, increasing the risk of injury.
Smeal will notify owners, and dealers will ask the customer to return the affected controller to Akron Brass for a software update, free of charge. The recall began on January 15, 2021. Owners may contact Smeal customer service at 1-800-867-6478. Smeal's number for this recall is 20-17.
Steering Column Support Structure May Crack
If the steering column loosens from the mounting structure, steering control can become affected, increasing the risk of a crash.
PACCAR will notify owners, and dealers will inspect the 520 models right hand stand-pp steering column structure and replace it if cracks are present, as well as add additional support brackets to the new (if replaced) or existing structure, free of charge. Additionally, for the 520 models, dealers will install a large gusset with triangulating support for the column bracket, free of charge. Owner notification letters were mailed July 30, 2021. Owners may contact Peterbilt customer service at 1-940-591-4220. PACCAR's number for this recall is 21PBA.
Yukon OCT Spinal System Yukon Anti-Torque Alignment Tube - Product Usage: The Anti-Torque Alignment Tube (the Alignment Tube ) provides counter rotation to reduce the torque applied to the anatomy when the size 15 Torque limiting shaft (the shaft is used to tighten the Yukon Set Screw to the specified torque.
Shafts do not pass through the inner cannula of the Anti-Torque Alignment Tube from Lot KTGG due to a manufacturing nonconformance. This could result in a delay of surgery or result in surgical intervention later on.
Our records indicate Stryker previously distributed catalog no. 7601-9001, Lot KTGG to your location in a Stryker Loaner Set. The nonconforming instrument was subsequently identified and quarantined during routine processing of loaner sets by Stryker at its Leesburg facility. This communication is being made for notification purposes only. The only action requested of you is to complete the Business Reply form found on the following page and return it to the email addresses referenced in the form. If you have any questions or concerns, please contact Stryker Regulatory Compliance at 201-749-8090. On behalf of Stryker we thank you sincerely for your help and support in completing the Business Reply Form and returning it to Stryker by November 6th, 2020.
D-0012 3COR 12MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws and the TSI Quick Start Distraction Screws products are intended for the distraction in the anterior approach to the cervical spine from C2 thru C7. The products are to be used by trained surgeons and are designed for use with TSI distractors and screwdrivers.
The items identified for recall are labeled as sterile. However, the manufacturer has found that product packaging for the lots listed above may be damaged, potentially exposing the product to non sterile conditions. This situation presents a risk of infection to patients.
On 02/21/2019 the firm issued a recall notice to affected consignees. The recall notification informed the consignees of the following: Customers should immediately remove all identified products and contact TSI to receive an RMA and shipping instructions. 2. Contact information for returns: Name: Nicole Burrell or Val Saucedo Telephone: 713 726-0886 Email address: custservice@ tedansurgica.com Fax 713 726-0846 In addition, if you have distributed the identified product to end users, immediately identify all customers and notify them of this product recall in writing using the enclosed information. Your assistance is appreciated and necessary to prevent any possible injury to patients. Also as needed provide to these customers the attached recall response form for their completion and provide to TSI the name, address, and contact information for those customers. Other TSI distraction screws not identified as part of this recall may be used. However, as a precaution, always follow the instructions for use and carefully inspect sterile packaging for any breaches. If breaches are identified DO NOT USE THE PRODUCT and contact TSI immediately.