September 2018 recalls

633 recalls were announced in September 2018.

What the numbers show

Critical: 19
Severe: 188
High: 305
Moderate: 102
Low: 19

Of the 633 recalls this month scored against our rubric, 3% are Critical, 30% are Severe.

Which agencies issued them

501–600 of 633

SevereFDA (Drugs)·D-1140-2018·2018-09-05
Torrent Pharma Recalls Amlodipine and Valsartan Tablets Due to Carcinogen Impurity
Torrent Pharma Inc. is recalling specific batches of Amlodipine and Valsartan Tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.
Product
Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-207-30
Category
Drug
Distribution
Distributed nationwide
SevereNHTSA·18V588000·2018-09-05
Navistar Recalls International Trucks Due to Fuel Line Burst Risk
Navistar is recalling specific International trucks because a restricted fuel pump screen may cause the fuel line to burst, leading to fuel leaks or engine stalling.
Product
INTERNATIONAL — INTERNATIONAL PROSTAR, LONESTAR, PAYSTAR, HX
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·18E088000·2018-09-05
AXN Heavy Duty Recalls Trailer Axles Due to Wheel Separation Risk
AXN Heavy Duty LLC is recalling certain trailer axles because the wheel end nut locking device may not be properly installed, allowing the wheel end to separate from the axle.
Product
SUSPENSION:REAR:AXLE:NON-POWERED AXLE ASSEMBLY recall
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1162-2018·2018-09-05
Auro Pharmacies Recalls Methyl-Cobalamin Injectable Due to Sterility Concerns
Auro Pharmacies is recalling 81 vials of Methyl-Cobalamin injectable because processes and equipment were inadequate to assure sterility.
Product
Methyl-Cobalamin injectable, 10 mg/mL, 30 mL Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
Category
Drug
Distribution
Distributed nationwide
SevereNHTSA·18V590000·2018-09-05
Fabform Recalls 2017-2018 Power Tilt Dump Trailers Due to Hinge Fracture Risk
Fabform is recalling 2017-2018 Power Tilt dump trailers because welded hinges may fracture, causing the dump box to fall unexpectedly and increasing the risk of injury or death.
Product
FABFORM — FABFORM POWER TILT DUMP TRAILER
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1159-2018·2018-09-05
Auro Pharmacies Recalls Glutathione Injectable Due to Sterility Concerns
Auro Pharmacies is recalling 183 vials of Glutathione injectable because inadequate processes and equipment were used to assure the sterility of the product.
Product
Glutathione injectable, 200 mg/mL, 30 mL Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1147-2018·2018-09-05
Pharmcore Recalls Human Chorionic Gonadotropin Vials Due to Sterility Concerns
Pharmcore Inc. is recalling 5,718 vials of Human Chorionic Gonadotropin 5000 IU due to a lack of assurance of sterility.
Product
Human Chorionic Gonadotropin 5000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-1903-2018·2018-09-05
Ararat Eggplant Paste Recalled Due to High pH Levels
Artashes LLC is recalling Ararat Eggplant Paste because FDA inspections found pH levels above the scheduled process.
Product
Ararat Eggplant Paste 18.3 oz. glass jar; Ingredients: Eggplants, Red pepper (fresh and grinded), tomato paste, vegetable oil, onion, garlic, carrot, green salt. Product of Armenia; Exclusively imported and distributed by: Kradjian Importing Co., Inc. Glendale, C
Category
Food
Distribution
1 state
SevereFDA (Drugs)·D-1157-2018·2018-09-05
Auro Pharmacies Recalls Calcium Gluconate Injectable Due to Sterility Concerns
Auro Pharmacies is recalling 167 vials of Calcium Gluconate injectable because processes and equipment were inadequate to assure sterility.
Product
Calcium Gluconate injectable, 10%, 50 ml Single Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
Category
Drug
Distribution
Distributed nationwide
SevereUSDA FSIS·076-2018·2018-09-05
Wayne Farms Recalls Frozen Chicken Products Due to Metal Contamination
Wayne Farms is recalling approximately 438,960 pounds of frozen, fully cooked chicken products that may contain metal pieces. Consumers are advised not to consume these items.
Product
Wayne Farms LLC — Wayne Farms, LLC Recalls Fully Cooked Chicken Products due to Possible Foreign Matter Contamination
Category
Food
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1158-2018·2018-09-05
Auro Pharmacies Recalls Dexpanthenol Injectable Vials Due to Sterility Concerns
Auro Pharmacies, Inc. is recalling 91 vials of Dexpanthenol injectable due to inadequate processes and equipment to assure sterility.
Product
Dexpanthenol injectable, 250 mg/mL, 10 mL Single Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-1914-2018·2018-09-05
Howard Calcagno Farms Recalls Cilantro Due to Cyclospora Contamination Risk
Howard Calcagno Farms is recalling cilantro shipped in cardboard boxes due to a potential for contamination with Cyclospora cayetanensis. The product was distributed in Oregon.
Product
Cilantro was shipped in card board boxes that are labeled with the firm name "Howard Calcagno, Aurora, OR 97002".
Category
Food
Distribution
1 state
SevereNHTSA·18V579000·2018-09-05
Toyota Recalls 2016-2018 Prius Vehicles for Electrical Fire Risk
Toyota is recalling 2016-2018 Prius vehicles because a worn engine wire harness could cause an electrical short and increase the risk of a fire.
Product
TOYOTA — TOYOTA PRIUS
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1131-2018·2018-09-05
AvKARE Recalls Valsartan Tablets Due to Carcinogen Impurity
AvKARE is recalling specific lots of Valsartan 80 mg tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.
Product
Valsartan Tablets, USP 80 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-784-15 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1146-2018·2018-09-05
RemedyRepack Recalls Amlodipine/Valsartan/HCTZ Tablets Due to NDMA Contamination
RemedyRepack Inc. is recalling Amlodipine/Valsartan/HCTZ tablets in South Carolina due to trace amounts of NDMA, a possible impurity.
Product
Amlodipine/Valsartan/HCTZ 10mg/320mg/25mg Tablet, Rx Only (HDPE 90cc Bottles in cardboard trays) MFG Torrent Pharma LTD, Indrad, India 38272, NDC #70518-1220-0
Category
Drug
Distribution
1 state
SevereFDA (Devices)·Z-2951-2018·2018-09-05
Haemonetics OrthoPAT Reservoirs Recalled Due to Missing Cannula
Haemonetics is recalling 348 OrthoPAT QuickConnect Reservoirs because a missing cannula prevents blood from being emptied and processed.
Product
Haemonetics¿ OrthoPAT¿ System-OPAT QuickConnect Reservoirs. Product Code: OPT-R-1000 The OrthoPAT orthopedic perioperative autotransfusion system indicated for use to salvage RBCs from blood lost intraoperatively and postoperatively during surgical procedures
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1152-2018·2018-09-05
Pharmcore Recalls Human Chorionic Gonadotropin Vials Due to Sterility Concerns
Pharmcore Inc. is recalling 3,351 vials of Human Chorionic Gonadotropin 6000 IU due to a lack of assurance of sterility.
Product
Human Chorionic Gonadotropin 6000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1151-2018·2018-09-05
Pharmcore Recalls Human Chorionic Gonadotropin Vials Due to Sterility Concerns
Pharmcore Inc. is recalling 2,085 vials of Human Chorionic Gonadotropin 4000 IU nationwide due to a lack of assurance of sterility.
Product
Human Chorionic Gonadotropin 4000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-1905-2018·2018-09-05
Ararat Cut Beets Recalled Due to High pH Levels
Artashes LLC is recalling Ararat Cut Beets because FDA inspections found pH levels above the scheduled process.
Product
Ararat Cut Beets; 19 oz. glass jar; Ingredients: Cut Beets, Water, Salt, Sugar, Citric Acid. Product of Armenia; Exclusively imported and distributed by: Kradjian Importing Co., Inc. Glendale, CA
Category
Food
Distribution
1 state
SevereFDA (Drugs)·D-1156-2018·2018-09-05
Auro Pharmacies Recalls CoEnzyme-Q10 Injectable Due to Sterility Concerns
Auro Pharmacies is recalling 39 vials of CoEnzyme-Q10 injectable because inadequate processes and equipment failed to assure product sterility.
Product
CoEnzyme-Q10 injectable, 20 mg/mL, 10 mL Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1130-2018·2018-09-05
AvKARE Recalls Valsartan Tablets Due to Carcinogen Impurity in API
AvKARE is recalling Valsartan Tablets 40 mg because a carcinogen impurity was detected in the active pharmaceutical ingredient used to manufacture the drug.
Product
Valsartan Tablets, USP 40 mg Rx Only NDC 50268-783-15 50 Tablets (5x10) Unit Dose Manufactured for: AvKARE, Inc. Pulaski, TN 38478
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1163-2018·2018-09-05
Auro Pharmacies Recalls Testosterone Injectable Due to Sterility Concerns
Auro Pharmacies is recalling 43 vials of Testosterone Cypionate/Enanthate injectable because inadequate processes and equipment failed to assure product sterility.
Product
Testosterone Cypionate/Enanthate injectable, 126/54 mg/mL, packaged in a) 3 mL and b) 5 mL Multiple Dose vials, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-1906-2018·2018-09-05
Coca-Cola Recalls Minute Maid Tropical Blend Juice Due to Glass
The Coca-Cola Company is recalling 432 bottles of Minute Maid Tropical Blend juice because foreign matter believed to be glass was found in retained samples.
Product
Consumer Packaging (PET bottle): Minute Maid TROPICAL BLEND Flavored Juice Beverage 12 FL OZ (355mL), JAN0719NPA, UPC: 0 25000 06229 2. Master Case: packaged 24/12 fl.oz., GTIN number 00025000062414 (no UPC)
Category
Food
Distribution
1 state
SevereFDA (Drugs)·D-1133-2018·2018-09-05
AvKARE Recalls Valsartan Tablets Due to Carcinogen Impurity
AvKARE Inc. is recalling Valsartan Tablets 320 mg because a carcinogen impurity was detected in the active pharmaceutical ingredient.
Product
Valsartan Tablets, USP 320 mg Rx Only 30 Tablets (6x5) Unit Dose NDC 50268-786-13 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1148-2018·2018-09-05
Pharmcore Recalls Human Chorionic Gonadotropin Vials Due to Sterility Concerns
Pharmcore Inc. is recalling 864 vials of Human Chorionic Gonadotropin 11000 IU due to a lack of assurance of sterility. The affected lots were distributed nationwide.
Product
Human Chorionic Gonadotropin 11000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1141-2018·2018-09-05
Torrent Pharma Recalls Amlodipine, Valsartan, and Hydrochlorothiazide Tablets Due to Impurity
Torrent Pharma Inc. is recalling specific batches of Amlodipine, Valsartan, and Hydrochlorothiazide tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.
Product
Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/320 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-325-30
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1160-2018·2018-09-05
Auro Pharmacies Recalls Methyl-Cobalamin Injectable Due to Sterility Concerns
Auro Pharmacies, Inc. is recalling 114 vials of Methyl-Cobalamin injectable because inadequate processes and equipment failed to assure product sterility.
Product
Methyl-Cobalamin injectable, 1 mg/mL, packaged in a) 5 mL and b) 30 mL Multiple Dose vials, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1138-2018·2018-09-05
Torrent Pharma Recalls Amlodipine and Valsartan Tablets Due to Impurity
Torrent Pharma Inc. is recalling Amlodipine and Valsartan Tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.
Product
Amlodipine and Valsartan Tablets, USP, 5 mg/320 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-205-30
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1144-2018·2018-09-05
Torrent Pharma Recalls Amlodipine, Valsartan, and Hydrochlorothiazide Tablets
Torrent Pharma Inc. is recalling specific batches of Amlodipine, Valsartan, and Hydrochlorothiazide tablets due to the detection of a carcinogen impurity in the active pharmaceutical ingredient.
Product
Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-328-30
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1166-2018·2018-09-05
Auro Pharmacies Recalls Folic Acid Injectable Due to Sterility Concerns
Auro Pharmacies, Inc. is recalling 40 vials of Folic Acid injectable due to inadequate processes and equipment to assure sterility.
Product
Folic Acid injectable, 10 mg/ml, 30 ml Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1139-2018·2018-09-05
Torrent Pharma Recalls Amlodipine and Valsartan Tablets Due to Impurity
Torrent Pharma Inc. is recalling Amlodipine and Valsartan Tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.
Product
Amlodipine and Valsartan Tablets, USP, 10 mg/160mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-206-30
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1161-2018·2018-09-05
Auro Pharmacies Recalls Methyl-Cobalamin Injectable Due to Sterility Concerns
Auro Pharmacies, Inc. is recalling 90 vials of Methyl-Cobalamin injectable because inadequate processes and equipment were used to assure sterility.
Product
Methyl-Cobalamin injectable, 5 mg/mL, 30 mL Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2926-2018·2018-09-05
Stanbio AC Power Adapter Recall for HemoPoint H2 Meter
Stanbio Laboratory is recalling AC power adapters for the HemoPoint H2 meter because the adapter plate may crack or detach, exposing live electrical contacts.
Product
Stanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series. The firm name on the label for the HemoPoint H2 shows Manufactured by EKF-diagnostic GmbH, Germany.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1134-2018·2018-09-05
Torrent Pharma Recalls Valsartan Tablets Due to Carcinogen Impurity
Torrent Pharma Inc. is recalling specific batches of Valsartan Tablets USP, 80mg, because a carcinogen impurity was detected in the active pharmaceutical ingredient.
Product
Valsartan Tablets USP, 80mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-068-90
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2941-2018·2018-09-05
MedComp Recalls DUO FLOW Custom Trays Due to Suture Wing Cracking
Medical Components, Inc dba MedComp is recalling DUO FLOW Custom Trays because suture wings may crack or break, posing risks of catheter dislocation, bleeding, and air emboli.
Product
DUO FLOW CUSTOM TRAYS; TRAY #414 TRAY #415 TRAY #67
Category
Medical Device
Distribution
Distributed nationwide
SevereNHTSA·18V589000·2018-09-05
Volvo Recalls 2019 XC60 Hybrid Vehicles Due to Charging System Fire Risk
Volvo is recalling 2019 XC60 hybrid vehicles because capacitors in certain charging systems may fail, posing a shock or fire hazard.
Product
VOLVO — VOLVO XC60
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1165-2018·2018-09-05
Auro Pharmacies Recalls Testosterone Enanthate/Cypionate Injectable Due to Sterility Concerns
Auro Pharmacies is recalling 11 vials of Testosterone Enanthate/Cypionate injectable because the manufacturer could not assure the sterility of the product.
Product
Testosterone Enanthate/Cypionate injectable, 126/54 mg/mL, packaged in a) 3 mL and b) 5 mL Multiple Dose vials, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1143-2018·2018-09-05
Torrent Pharma Recalls Amlodipine, Valsartan, and Hydrochlorothiazide Tablets Due to Impurity
Torrent Pharma Inc. is recalling specific batches of Amlodipine, Valsartan, and Hydrochlorothiazide tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.
Product
Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/12.5 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-327-30
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1164-2018·2018-09-05
Auro Pharmacies Recalls Testosterone Cypionate/Enanthate Injectable Due to Sterility Concerns
Auro Pharmacies is recalling 32 vials of Testosterone Cypionate/Enanthate injectable because inadequate processes and equipment failed to assure the sterility of the product.
Product
Testosterone Cypionate/Enanthate injectable, 200/50 mg/mL, packaged in a) 5 mL and 8 mL Multiple Dose vials, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
Category
Drug
Distribution
Distributed nationwide
HighUSDA FSIS·077-2018·2018-09-05
New York Style Sausage Co. Recalls Raw Chorizo for Undeclared Sesame
New York Style Sausage Co. is recalling raw chorizo sausage because it contains undeclared sesame seed. No adverse reactions have been reported.
Product
NEW YORK STYLE SAUSAGE CO. — New York Style Sausage Co. Recalls Raw Chorizo Sausage Products due to Misbranding and an Undeclared Ingredient
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-1852-2018·2018-09-05
Marsee Foods Recalls Cafe YUMM! Chocolate Chip Cookies for Undeclared Peanuts
Marsee Foods Inc is recalling Cafe YUMM! Chocolate Chip Cookies because they may contain undeclared peanuts. The cookies were sold at Cafe Yumm! restaurants in Oregon and Washington.
Product
Chocolate Chip Cookies, brand Cafe YUMM! Product is packaged in shrink wrapped master case. Each master case contains two boxes and each box contains 24 cookies. The master case is taped shut and labeled with the contents and production date, along with a lot code. The lab
Category
Food
Distribution
2 states
HighFDA (Devices)·Z-2936-2018·2018-09-05
MedComp Recalls Hemodialysis Catheter Kits Due to Suture Wing Cracking
Medical Components, Inc. is recalling hemodialysis catheter insertion kits because suture wings may crack or break, posing a risk of patient injury.
Product
Duo-Flow Catheter Full Tray; MCDLT3500 MCDLT4000 MCDLT4400 MCDLT4424# Hemodialysis catheter insertion kits
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1922-2018·2018-09-05
Howard Calcagno Farms Recalls Beets for Potential Cyclospora Contamination
Howard Calcagno Farms is recalling beets shipped in cardboard boxes due to a potential for contamination with Cyclospora cayetanensis.
Product
Beet was shipped in card board boxes that are labeled with the firm name "Howard Calcagno, Aurora, OR 97002".
Category
Food
Distribution
1 state
HighFDA (Food)·F-1910-2018·2018-09-05
Howard Calcagno Farms Recalls Kale Due to Cyclospora Contamination Risk
Howard Calcagno Farms is recalling kale shipped in cardboard boxes due to potential contamination with Cyclospora cayetanensis. The product was distributed in Oregon.
Product
Kale was shipped in card board boxes that are labeled with the firm name "Howard Calcagno, Aurora, OR 97002".
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-2942-2018·2018-09-05
MedComp Recalls Duo Flow Double Lumen Catheters Due to Suture Wing Cracking
Medical Components, Inc dba MedComp is recalling Duo Flow double lumen catheters because suture wings may crack or break, posing a risk of catheter dislocation, bleeding, and air emboli.
Product
DUO FLOW DOUBLE LUMEN CATHETER, XTP114CT, XTP114MT, ; RAULERSON DUO FLOW IJ DOUBLE LUMEN CATHETER/CATHETER SET, XTP114IJC, XTP114IJS, XTP114IJSE, XTP114MT-C, XTP116IJC, XTP116IJS, XTP116IJSE RAULERSON PRE-CURVED DUO-FLOW IJ DOUBLE LUMEN CATHETER W/SOFT TIP SET, W/MINI SCALPEL,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1926-2018·2018-09-05
Howard Calcagno Farms Recalls Lacinato Kale Due to Cyclospora Risk
Howard Calcagno Farms is recalling Lacinato Kale due to potential contamination with Cyclospora cayetanensis. The product was distributed in Oregon.
Product
Lacinato Kale was shipped in card board boxes that are labeled with the firm name "Howard Calcagno, Aurora, OR 97002".
Category
Food
Distribution
1 state
HighFDA (Food)·F-1920-2018·2018-09-05
Howard Calcagno Farms Recalls Parsley Due to Cyclospora Contamination Risk
Howard Calcagno Farms is recalling parsley shipped in cardboard boxes labeled with the firm name due to a potential for contamination with Cyclospora cayetanensis.
Product
Parsley was shipped in card board boxes that are labeled with the firm name "Howard Calcagno, Aurora, OR 97002".
Category
Food
Distribution
1 state
HighFDA (Food)·F-1912-2018·2018-09-05
Howard Calcagno Farms Recalls Mustard Due to Cyclospora Contamination Risk
Howard Calcagno Farms is recalling mustard shipped in cardboard boxes due to a potential for contamination with Cyclospora cayetanensis.
Product
Mustard was shipped in card board boxes that are labeled with the firm name "Howard Calcagno, Aurora, OR 97002".
Category
Food
Distribution
1 state
HighCPSC·18214·2018-09-05
Rust-Oleum Recalls Black Satin Countertop Coating Due to Lead Violation
Rust-Oleum is recalling about 1,800 cans of black satin countertop coating because they contain lead levels that exceed the federal lead paint ban.
Product
Rust-Oleum black satin countertop coating
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Food)·F-1918-2018·2018-09-05
Howard Calcagno Farms Recalls Bok Choy Due to Cyclospora Contamination Risk
Howard Calcagno Farms is recalling 30-pound boxes of Bok Choy distributed in Oregon due to a potential for contamination with Cyclospora cayetanensis.
Product
Bok Choy was shipped in card board boxes that are labeled with the firm name "Howard Calcagno, Aurora, OR 97002".
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-2950-2018·2018-09-05
Haemonetics OrthoPAT System-Integrated Set Recalled Due to Missing Cannula
Haemonetics is recalling OrthoPAT System-Integrated Sets because missing cannulas prevent blood from emptying, making the collected blood unusable.
Product
Haemonetics OrthoPAT System-Integrated Set. Product Code: 1150H-00 OrthoPAT orthopedic perioperative autotransfusion system indicated for use to salvage RBCs from blood lost intraoperatively and postoperatively during surgical procedures
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1928-2018·2018-09-05
Howard Calcagno Farms Recalls Mint for Potential Cyclospora Contamination
Howard Calcagno Farms is recalling 5 dozen mint due to potential contamination with Cyclospora cayetanensis. The product was distributed in Oregon.
Product
Mint was shipped in card board boxes that are labeled with the firm name "Howard Calcagno, Aurora, OR 97002".
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-2934-2018·2018-09-05
MedComp Recalls Duo-Flow Hemodialysis Catheter Sets Due to Suture Wing Cracking
Medical Components, Inc dba MedComp is recalling Duo-Flow Double Lumen Soft Tip CRRT/ABP Catheter Sets because suture wings may crack or break, posing a risk of patient injury.
Product
Duo-Flow Double Lumen Soft Tip CRRT/ABP Catheter Set; DL11/24 . Hemodialysis catheter insertion kits
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2925-2018·2018-09-05
Stryker Mako Vizadisc Hip Procedure Tracking Kit Recall for Detection Failure
Mako Surgical Corporation is recalling specific lots of the Stryker Mako Vizadisc Hip Procedure Tracking Kit because damaged reflective material may prevent camera detection.
Product
Stryker Mako Vizadisc Hip Procedure Tracking Kit
Category
Medical Device
Distribution
35 states
HighFDA (Food)·F-1911-2018·2018-09-05
Howard Calcagno Farms Recalls Collards Due to Cyclospora Contamination Risk
Howard Calcagno Farms is recalling collards shipped in cardboard boxes labeled with the firm's name in Aurora, Oregon, due to a potential for contamination with Cyclospora cayetanensis.
Product
Collards were shipped in card board boxes that are labeled with the firm name "Howard Calcagno, Aurora, OR 97002".
Category
Food
Distribution
1 state
HighFDA (Food)·F-1901-2018·2018-09-05
Hostess Brownies Cookies 'n Crème Recalled for Missing Egg Allergen Labeling
Hostess Brands is recalling specific lots of Brownies Cookies 'n Crème because the packaging fails to declare egg in the 'Contains' statement, despite egg being an ingredient.
Product
Hostess Brownies Cookies 'n Cr¿me packaged in the following ways: 1) 6 Brownies individually wrapped packaged in a cardboard box Net Wt. 8.68 OZ (246 g) UPC 888109113575; 2) 2 Brownies packaged in a cardboard box Net Wt. 2.89 OZ (82 g) UPC 888109012021
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-1921-2018·2018-09-05
Howard Calcagno Farms Recalls Italian Parsley Due to Cyclospora Contamination Risk
Howard Calcagno Farms is recalling 5 dozen of Italian parsley shipped in Oregon due to a potential for contamination with Cyclospora cayetanensis.
Product
Italian Parsley was shipped in card board boxes that are labeled with the firm name "Howard Calcagno, Aurora, OR 97002".
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-2932-2018·2018-09-05
MedComp Recalls Hemodialysis Catheter Kits Due to Suture Wing Cracking Risk
Medical Components, Inc. is recalling specific hemodialysis catheter insertion kits because suture wings may crack or break, posing a risk of patient injury.
Product
Duo-Flow XTP Straight Full Set; Hemodialysis catheter insertion kits, AAC02106 AAC02107 AAC02108
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1925-2018·2018-09-05
Howard Calcagno Farms Recalls Bright Light Chard Due to Cyclospora Risk
Howard Calcagno Farms is recalling Bright Light Chard due to a potential for contamination with Cyclospora cayetanensis. The product was distributed in Oregon.
Product
Bright Light Chard was shipped in card board boxes that are labeled with the firm name "Howard Calcagno, Aurora, OR 97002".
Category
Food
Distribution
1 state
HighFDA (Food)·F-1929-2018·2018-09-05
Premo Turkey & Cheese Wedge Sandwiches Recalled for Listeria Risk
Lipari Foods is recalling Premo Turkey & Cheese Wedge sandwiches due to potential Listeria monocytogenes contamination.
Product
Premo Brand Turkey & Cheese Wedge sandwiches 5 OZ retail UPC 612510002018 Plastic triangle sandwich wedge container with plastic film. Refrigerated. 4, 5 OZ retail units per wholesale case.
Category
Food
Distribution
11 states
HighFDA (Devices)·Z-2955-2018·2018-09-05
GE Carestation 30 Anesthesia Systems Recalled for Gas Switch Defect
GE Medical Systems is recalling 252 Carestation 30 anesthesia systems worldwide because a gas switch may unexpectedly change position, potentially causing hypoxia.
Product
GE Carestation 30 anesthesia systems
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2928-2018·2018-09-05
Siemens RAPIDPoint 500 Blood Gas Analyzer Recalled for Hydroxocobalamin Interference
Siemens recalls RAPIDPoint 500 Blood Gas Analyzers because Hydroxocobalamin may interfere with test results, potentially leading to incorrect medical assessments.
Product
RAPIDPoint 500 Blood Gas Analyzer; 10492730, 1069855, 10696857, 10697306 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolytes, glucose, lactate, neonatal total bilirubin and full CO-oximetry incl
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2956-2018·2018-09-05
GE 9100c NXT anesthesia systems recalled for gas switch defect
GE Medical Systems is recalling 401 anesthesia systems worldwide because a gas switch may unexpectedly change position, potentially causing hypoxia.
Product
GE 9100c NXT anesthesia systems
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2946-2018·2018-09-05
Civco Needle Guide Recall Due to Missing or Inadequate Adhesive
Civco Medical Instruments is recalling 107 units of CIVCO Needle Guides because the assembly may lack sufficient adhesive to hold the cannula in place.
Product
CIVCO Needle Guide, REF 676-144, QTY 24, STERILE EO
Category
Medical Device
Distribution
0 states
HighFDA (Food)·F-1916-2018·2018-09-05
Howard Calcagno Farms Recalls Red Leaf Lettuce Due to Cyclospora Risk
Howard Calcagno Farms is recalling Red Leaf Lettuce shipped in Oregon due to a potential for contamination with Cyclospora cayetanensis.
Product
Red Leaf Lettuce was shipped in card board boxes that are labeled with the firm name "Howard Calcagno, Aurora, OR 97002".
Category
Food
Distribution
1 state
HighFDA (Food)·F-1908-2018·2018-09-05
Ochoa's Queseria Recalls Mexican Style Ricotta Cheese for Undeclared Milk Allergen
Ochoa's Queseria LLC is recalling Don Froylan Requeson Mexican Style Ricotta Cheese because the label fails to declare milk, a major food allergen.
Product
Mexican Style Ricotta Cheese labeled, "Don Froylan Requeson***Mexican Style Ricotta Cheese***Ingredients: Pasteurized Whey, Salt***" 1lb. (16 oz.) and bulk plastic bags in 2lb. and 5lb.
Category
Food
Distribution
2 states
HighFDA (Drugs)·D-1128-2018·2018-09-05
Baxter Recalls 0.9% Sodium Chloride Injection Due to CGMP Deviations
Baxter Healthcare is recalling 33,600 bags of 0.9% Sodium Chloride Injection USP due to Current Good Manufacturing Practice (CGMP) deviations. The product was distributed only in Texas and Mississippi.
Product
SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
Category
Drug
Distribution
2 states
HighFDA (Devices)·Z-2938-2018·2018-09-05
MedComp Duo-Flow Double Lumen Catheters Recalled for Suture Wing Cracking
Medical Components, Inc. is recalling Duo-Flow Double Lumen Catheters because suture wings may crack or break, posing risks of catheter dislocation, bleeding, and air emboli.
Product
Duo-Flow Double Lumen Catheter Only/Catheter Set; T114C T114M T116C T116M T116ME T118C T118M T118ME T119M
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2940-2018·2018-09-05
MedComp Recalls Soft-Line Duo-Flow Catheters Due to Suture Wing Cracking
Medical Components, Inc. is recalling Soft-Line Duo-Flow catheters because suture wings may crack or break, posing a risk of catheter dislocation, bleeding, or air emboli.
Product
SOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER/CATHETER SET; T94C T94M T96M T98M
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1855-2018·2018-09-05
Morgan Foods Recalls Tomato Condensed Soup Due to Undeclared Allergens
Morgan Foods is recalling 6,168 cans of Tomato Condensed Soup because the product contains cream of mushroom soup with undeclared milk and soy.
Product
Tomato Condensed Soup, 26 oz (1 LB 10 OZ) 737 g, 307 x 512 Can, Family Size, 12 cans per tray, shelf stable
Category
Food
Distribution
1 state
HighFDA (Food)·F-1857-2018·2018-09-05
Tipu's Chai Sweetened Masala Chai Recalled for Undeclared Milk
Tipu's Chai is recalling Sweetened Masala Chai boxes because the packaging fails to declare milk, which is present in the single-serve sachets inside.
Product
Tipu's Chai - Sweetened Masala Chai, Net wt.7.5 oz. per box. UPC #: 7 19196 20035 3. Each box contains five single serve sachet packets of Chai Tea Latte. Single serve sachet Chai Tea Latte packets, net wt. 1.1 oz per packet. UPC 7 19196 20073 5. The LABEL of Sweetened Mas
Category
Food
Distribution
1 state
HighFDA (Food)·F-1913-2018·2018-09-05
Howard Calcagno Farms Recalls Spinach Due to Cyclospora Contamination Risk
Howard Calcagno Farms is recalling spinach shipped in cardboard boxes labeled with the firm's name in Aurora, Oregon, due to a potential for contamination with Cyclospora cayetanensis.
Product
Spinach was shipped in card board boxes that are labeled with the firm name "Howard Calcagno, Aurora, OR 97002".
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-2929-2018·2018-09-05
Siemens RAPIDLab Blood Gas Analyzer Recalled for Hydroxocobalamin Interference
Siemens Healthcare Diagnostics is recalling 138 RAPIDLab 1245 Blood Gas Analyzers because Hydroxocobalamin may interfere with test results, potentially leading to incorrect medical assessments.
Product
RAPIDLab 1245 Blood Gas Analyzer; 10321844, 10337179, 10491393 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolytes, glucose, lactate, neonatal total bilirubin and full CO-oximetry including tota
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2930-2018·2018-09-05
Siemens RAPIDLab 1265 Blood Gas Analyzer Recalled for Hydroxocobalamin Interference
Siemens is recalling 2,357 RAPIDLab 1265 Blood Gas Analyzers because Hydroxocobalamin may interfere with test results, potentially leading to incorrect medical assessments.
Product
RAPIDLab 1265 Blood Gas Analyzer; 110321852, 10470366, 10491395 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolytes, glucose, lactate, neonatal total bilirubin and full CO-oximetry including tot
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2939-2018·2018-09-05
MedComp Recalls Soft-Line Duo-Flow Double Lumen Catheter Trays
Medical Components, Inc dba MedComp is recalling Soft-Line Duo-Flow Double Lumen Catheter Trays because suture wings may crack or break, posing a risk of patient injury.
Product
SOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER TRAY; T3500 T4000 T4400 T4424
Category
Medical Device
Distribution
Distributed nationwide
HighCPSC·18215·2018-09-05
Hawthorne Hydroponics Recalls Ideal-Air Humidifiers Due to Fire and Shock Hazards
Hawthorne Hydroponics is recalling Ideal-Air 175-pint industrial grade humidifiers because they can overheat, posing fire and shock hazards. No injuries have been reported.
Product
Ideal-Air 175-pint industrial grade humidifiers
Category
Consumer Product
Distribution
Distributed nationwide
HighCPSC·18765·2018-09-05
Polaris Recalls 2018 Ranger Recreational Off-Highway Vehicles Due to Crash Hazard
Polaris is recalling about 1,000 model year 2018 Ranger 500, 570, EV, and EV LI-ION vehicles because front lower control arms can separate, posing a crash hazard.
Product
Model year 2018 Polaris Ranger 500, Ranger 570, Ranger EV, and Ranger EV LI-ION recreational off-highway vehicles (ROVs)
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Food)·F-1917-2018·2018-09-05
Howard Calcagno Farms Recalls Romaine Lettuce Due to Cyclospora Risk
Howard Calcagno Farms is recalling romaine lettuce shipped in boxes labeled with the firm name in Aurora, Oregon, due to potential Cyclospora cayetanensis contamination.
Product
Romaine Lettuce was shipped in card board boxes that are labeled with the firm name "Howard Calcagno, Aurora, OR 97002".
Category
Food
Distribution
1 state
HighFDA (Food)·F-1923-2018·2018-09-05
Howard Calcagno Farms Recalls Red Chard Due to Cyclospora Contamination Risk
Howard Calcagno Farms is recalling Red Chard shipped in boxes labeled with the firm's name in Aurora, Oregon, due to potential contamination with Cyclospora cayetanensis.
Product
Red Chard was shipped in card board boxes that are labeled with the firm name "Howard Calcagno, Aurora, OR 97002".
Category
Food
Distribution
1 state
HighFDA (Food)·F-1915-2018·2018-09-05
Howard Calcagno Farms Recalls Green Leaf Lettuce Due to Cyclospora Risk
Howard Calcagno Farms is recalling Green Leaf Lettuce shipped in Oregon due to potential contamination with Cyclospora cayetanensis.
Product
Green Leaf Lettuce was shipped in card board boxes that are labeled with the firm name "Howard Calcagno, Aurora, OR 97002".
Category
Food
Distribution
1 state
HighFDA (Food)·F-1927-2018·2018-09-05
Howard Calcagno Farms Recalls Dill for Potential Cyclospora Contamination
Howard Calcagno Farms is recalling dill due to a potential for contamination with Cyclospora cayetanensis. The product was distributed in Oregon.
Product
Dill was shipped in card board boxes that are labeled with the firm name "Howard Calcagno, Aurora, OR 97002".
Category
Food
Distribution
1 state
HighFDA (Food)·F-1919-2018·2018-09-05
Howard Calcagno Farms Recalls Napa Cabbage Due to Cyclospora Risk
Howard Calcagno Farms is recalling Napa Cabbage distributed in Oregon due to a potential for contamination with Cyclospora cayetanensis.
Product
Napa Cabbage was shipped in card board boxes that are labeled with the firm name "Howard Calcagno, Aurora, OR 97002".
Category
Food
Distribution
1 state
HighFDA (Food)·F-1924-2018·2018-09-05
Howard Calcagno Farms Recalls Green Chard Due to Cyclospora Contamination Risk
Howard Calcagno Farms is recalling green chard from Oregon due to a potential contamination with Cyclospora cayetanensis.
Product
Green Chard was shipped in card board boxes that are labeled with the firm name "Howard Calcagno, Aurora, OR 97002".
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-2927-2018·2018-09-05
Siemens RAPIDPoint 405 Blood Gas Analyzer Recalled for Interference
Siemens is recalling RAPIDPoint 405 Blood Gas Analyzers because Hydroxocobalamin may interfere with test results, potentially leading to incorrect medical assessments.
Product
RAPIDPoint 405 Blood Gas Analyzer; 10282093, 10310464, 10314817, 10317193, 10318999, 10320055, 10321238, 10322347, 10328278, 10328302, 10336784 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolyt
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2931-2018·2018-09-05
CSL Behring Recalls N Latex CDT Kits Due to Measurement Bias
CSL Behring is recalling N Latex CDT Kits because they may produce inaccurate results that are approximately 15% lower than expected.
Product
N Latex CDT Kit
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-2937-2018·2018-09-05
MedComp Duo-Flow XTP Straight Full Set Recalled for Suture Wing Cracking
Medical Components, Inc. is recalling Duo-Flow XTP Straight Full Sets because suture wings may crack or break, posing risks of catheter dislocation, bleeding, and air emboli.
Product
Duo-Flow XTP Straight Full Set, RMS02105 RMS02108
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2947-2018·2018-09-05
Civco Needle Guide Recall Due to Missing or Inadequate Adhesive
Civco Medical Instruments is recalling 3 units of CIVCO Needle Guides because missing or inadequate adhesive may fail to hold the cannula in place.
Product
CIVCO Needle Guide, REF 676-150, QTY 24, STERILE EO
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2935-2018·2018-09-05
MedComp Recalls Duo-Flow IJ Full Trays Due to Suture Wing Cracking
Medical Components, Inc. is recalling Duo-Flow IJ Full Trays because suture wings may crack or break, posing risks of catheter dislocation, bleeding, and air emboli.
Product
Duo-Flow IJ Full Tray; MCDLT114IJ MCDLT116IJ MCDLT118IJ
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2954-2018·2018-09-05
GE Carestation Anesthesia Systems Recalled for Gas Switch Defect
GE Medical Systems is recalling 310 anesthesia systems worldwide because a gas switch may unexpectedly change position, potentially causing hypoxia.
Product
GE Carestation 620/650/650c, A1 and A2 (non-US distribution) anesthesia systems
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2958-2018·2018-09-05
FDA Recalls Li-ion Battery Packs for BIS Monitoring Systems
The FDA is recalling Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems due to a Class II safety issue.
Product
Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems. Product Number/CFN: 186-0208 UDI-Device Identifier (GTIN/UPN): 10884521130319
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2933-2018·2018-09-05
MedComp Recalls Double Lumen CRRT Catheter Sets Due to Suture Wing Cracking
Medical Components, Inc dba MedComp is recalling specific hemodialysis catheter insertion kits because the suture wings may crack or break, posing a risk of patient injury.
Product
Double Lumen CRRT/ABP Catheter Set; Hemodialysis catheter insertion kits, DL 11/15 DL 11/20 DL 9/15
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2952-2018·2018-09-05
Luminex Recalls Verigene Enteric Pathogens Test Cartridges Due to False Positives
Luminex is recalling Verigene Enteric Pathogens Nucleic Acid Test Cartridges because they may produce elevated false positive results for Yersinia enterocolitica.
Product
Verigene Enteric Pathogens Nucleic Acid Test (EP) for detecting and identification of pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-Blair medium, collected from individuals with signs and symptoms of gastrointesti
Category
Medical Device
Distribution
17 states
ModerateFDA (Devices)·Z-2900-2018·2018-09-05
Stryker QUIKFLAP Cranium Plates Recalled for Packaging Compromise
Stryker is recalling QUIKFLAP cranium plates because the sterile packaging may become compromised after three years.
Product
QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01522S, for use on the cranium.
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-2944-2018·2018-09-05
Roche cobas p 612 Pre-Analytical System Recalled for Contamination Risk
Roche is recalling 12 units of the cobas p 612 pre-analytical system because sample material may contact the pipetting nozzle, potentially causing false positive test results.
Product
Roche cobas p 612 pre-analytical system (63x) Model: 07563116001 The cobas p 612 pre-analytical system is a computer controlled fully automatic system for sorting of open and closed barcoded and centrifuged and non-centrifuged sample tubes. The cobas p 612 is intended for u
Category
Medical Device
Distribution
5 states
ModerateFDA (Devices)·Z-2905-2018·2018-09-05
Stryker QUIKFLAP Cranium Plates Recalled for Sterile Barrier Compromise
Stryker Leibinger is recalling QUIKFLAP cranium plates because the sterile packaging may become compromised after three years, potentially affecting sterility.
Product
QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01531S, for use on the cranium
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-2948-2018·2018-09-05
Medline Sodium Chloride Injection Recalled for Incorrect Overwrap Packaging
Medline Industries is recalling 90,870 units of 0.9% Sodium Chloride Injection due to incorrect overwrap packaging. The product is intended for flushing IV catheters and tubing.
Product
Medline 0.9 % Sodium Chloride Injection, USP 5 mL in 10 mL Syringe ZR Intended for flushing IV catheters and IV tubing only.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2912-2018·2018-09-05
Stryker AXS PP Cranium Plates Recalled for Packaging Compromise
Stryker is recalling 22,831 AXS PP cranium plates because the sterile packaging may become compromised after three years.
Product
AXS PP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01541S, for use on the cranium
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-2923-2018·2018-09-05
Tecan Recalls Cortisol Saliva Luminescence Immunoassay Kits for Inaccurate Results
Tecan US, Inc. is recalling specific lots of the IBL International Cortisol Saliva Luminescence Immunoassay because the product generates cortisol values 1.3 to 1.8 times higher than the NIST standard.
Product
Cortisol Saliva Luminescence Immunoassay The IBL International Cortisol Saliva Luminescence immunoassay is intended for the in-vitro diagnostic quantitative determination of Cortisol in human saliva and for use as an aid in the diagnosis and treatment of adrenal disorders. Th
Category
Medical Device
Distribution
9 states
ModerateFDA (Devices)·Z-2911-2018·2018-09-05
Stryker AXS PP Cranium Plates Recalled for Packaging Compromise
Stryker is recalling 22,831 AXS PP cranium plates because the sterile packaging may become compromised after three years.
Product
AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01541S, for use on the cranium
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-2953-2018·2018-09-05
Sysmex Fluorocell PLT Reagent Recalled for Inaccurate Platelet Counts
Sysmex America is recalling Fluorocell PLT reagent because it may cause falsely low platelet and immature platelet fraction results.
Product
Sysmex XN-Series Fluorocell PLT, Catalog #CD994563. Distributed in the U.S.A. by Sysmex America, Inc., Lincolnshire, IL. Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets with the Sysmex XN-Series automated hematology analyzer
Category
Medical Device
Distribution
Distributed nationwide

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