May 2018 recalls

1,113 recalls were announced in May 2018.

What the numbers show

Critical: 47
Severe: 240
High: 488
Moderate: 304
Low: 34

Of the 1,113 recalls this month scored against our rubric, 4% are Critical, 22% are Severe.

Which agencies issued them

1001–1100 of 1113

SevereFDA (Drugs)·D-0697-2018·2018-05-02
Bayer Recalls Alka-Seltzer Plus Packages Due to Ingredient Label Mismatch
Bayer is recalling specific Alka-Seltzer Plus packages because the ingredients listed on the front sticker may not match the actual product inside the carton.
Product
All Alka-Seltzer Plus¿ packages with a full front panel instant Redeemable Coupon (IRC) affixed to the individual carton. The recalled products can be identified by checking the Bayer logo located on the lower left corner of the front of the carton. If the logo has an orange or g
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1532-2018·2018-05-02
BD Vacutainer Push Button Blood Collection Set Recalled for Sterility Issues
Becton Dickinson is recalling BD Vacutainer Push Button Blood Collection Sets because they do not meet the labeled sterility assurance level.
Product
BD Vacutainer¿ Push Button Blood Collection Set 0.8 x 19 mm x 305 mm 21G x ¿ x 12 Catalog 367344
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1523-2018·2018-05-02
Sofradim Versatex Monofilament Mesh Recalled for Hernia Recurrence Reports
Sofradim Production is recalling Versatex Monofilament Mesh due to patient reports of abdominal hernia recurrence following repair. The firm has updated instructions to warn surgeons about risks in specific procedures.
Product
Versatex Monofilament Mesh 50 x 50cm, Product No. VTX5050M The device is made out of a macroporous three-dimensional monofilament polyester textile. Its intended use is for the repair of abdominal wall hernias or other fascial deficiencies that require the addition of a reinfo
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1531-2018·2018-05-02
BD Vacutainer Push Button Blood Collection Set Recalled for Sterility Failure
Becton Dickinson & Company is recalling BD Vacutainer Push Button Blood Collection Sets because they do not meet the labeled sterility assurance level.
Product
BD Vacutainer¿ Push Button Blood Collection Set 0.6 x 19 mm x 305 mm 23G x ¿ x 12 (Catalog no 367342)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1118-2018·2018-05-02
Whole Foods Recalls Undeclared Egg Allergen in Iced Easter Cookies
Whole Foods Market is recalling decorated Easter cookies sold in nine Northern California locations because the signage failed to declare egg as an ingredient and allergen.
Product
Decorated (iced holiday cookies sold from self service cookie displays - cookies in the shape of eggs, bunnies and chicks. The signage by the displays do not declare egg as an ingredient of the cookies. Cookies are received in a 9 lb. bag Correct Ingredients: Unbleached, U
Category
Food
Distribution
0 states
HighFDA (Devices)·Z-1510-2018·2018-05-02
Stryker T5 Zipper Toga Sterile Garment Recall for Layer Separation
Stryker is recalling T5 Zipper Toga sterile garments because material layers may separate, posing a risk of exposure to contaminants.
Product
T5 Zipper Toga with Peel-Away Face Shield, (XL/T); Catalog number: 0400-850-100 Sterile personal protection garment
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1466-2018·2018-05-02
Zimmer Biomet Recalls Humeral Guide Wire Ball Tips Due to Packaging Seal Failure
Zimmer Biomet is recalling Humeral Guide Wire Ball Tips because the sterile packaging seal may fail, potentially compromising the device's sterility.
Product
Humeral Guide Wire Ball Tip 2.4 mm Diameter 70 cm Length; Item Number: 47-2255-008-00
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1513-2018·2018-05-02
BioFire FilmArray BCID Panel Recalled for False Positive Proteus Results
BioFire Diagnostics is recalling the FilmArray BCID Panel because it may produce false positive Proteus results when used with specific BD BACTEC blood culture bottles.
Product
FilmArray BCID Panel (Blood Culture Identification Panel), Catalog numbers RFIT-ASY-0126 (30 test kit) and RFIT-ASY-0127 (6 test kit), when used with all lots of BD BACTEC Blood Culture Bottles, Catalog numbers 442020, 442021, 442023, 442192, 442265, 442194, 442022, 442193, 44226
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1500-2018·2018-05-02
Stryker T4 Pullover Toga Recalled for Potential Material Separation
Stryker is recalling T4 Pullover Toga sterile garments because material layers may separate, posing a risk of exposure to contaminants.
Product
T4 Pullover Toga, (S/M); Catalog Number: 0400-710-000 Sterile personal protection garment
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1478-2018·2018-05-02
Terumo Flowmeter Module Recalled for Inaccurate Flow Readings
Terumo Cardiovascular Systems Corporation is recalling seven Flowmeter Modules for the Advanced Perfusion System 1 due to inaccurate flow readings that may be difficult to detect.
Product
Flowmeter Module (accessory to Terumo Advanced Perfusion System 1). Provides the interface between the flow sensor and the system.
Category
Medical Device
Distribution
3 states
HighFDA (Food)·F-1131-2018·2018-05-02
Frozen Parotta Recalled for Undeclared Milk Allergen
Maharaja Food Importers is recalling frozen Parotta products because the label lists ghee but fails to declare milk, a major allergen.
Product
Parotta Family Pack, UPC: 8 70400 00084 5, Frozen; and Small Parotta, UPC: 870400000012, Frozen
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1472-2018·2018-05-02
Zimmer Biomet Recalls Natural Nail System Guide Wires Due to Sterile Seal Failure
Zimmer Biomet is recalling 19,483 Natural Nail System Tear Drop Guide Wires because the sterile packaging seal may fail, potentially compromising sterility.
Product
Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter, 100 cm Length; Diameter; Item Number: 47-2490-097-01
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1505-2018·2018-05-02
Stryker T4 Zipper Toga sterile garments recalled for layer separation
Stryker is recalling T4 Zipper Toga sterile personal protection garments because material layers may separate, creating a risk of exposure to contaminants.
Product
T4 Zipper Toga (S/M); Catalog Number: 0400-810-000 Sterile personal protection garment
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0713-2018·2018-05-02
Lyne Laboratories Recalls Subpotent Fluocinolone Acetonide Topical Oil
Lyne Laboratories is recalling 23,453 units of Fluocinolone Acetonide Topical Oil because the product is subpotent. The recall is voluntary and classified as FDA Class II.
Product
FLUOCINOLONE ACETONIDE — FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE)
Category
Drug
Distribution
0 states
HighFDA (Food)·F-1145-2018·2018-05-02
Izzy's Maple Nut Ice Cream Recalled for Undeclared Peanut Residue
Izzy's Ice Cream is recalling Maple Nut ice cream in Minnesota due to possible undeclared peanut residue from walnuts.
Product
Izzy's Ice Cream, Maple Nut, One Pint (473 ml), UPC 51115-00106. Izzy's Ice Cream, 1100 2nd Street S., Minneapolis, MN 55415.
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-1527-2018·2018-05-02
Recall of EEA Hemorrhoid and Prolapse Stapler Sets Due to Welding Defect
Covidien LLC is recalling EEA Hemorrhoid and Prolapse Stapler Sets because a defective staple guide may cause bleeding or anastomotic leak during surgery.
Product
EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 3.5MM, Product Number HEM3335, GTIN Number 1 - 10884521047518, GTIN Number 2 - 20884521047515 Product Usage: The EEA Hemorrhoid and prolapse stapler set with DST Series Technology (instrument) is designed f
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1468-2018·2018-05-02
Zimmer Biomet Recalls Natural Nail System Tear Drop Guide Wires
Zimmer Biomet is recalling 19,483 Natural Nail System Tear Drop Guide Wires due to a potential failure of the sterile packaging seal.
Product
Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter, 70 cm length; Item Number: 47-2490-098-01
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1487-2018·2018-05-02
Integra LifeSciences Recalls TCC-EZ Total Contact Cast System
Integra LifeSciences is recalling 250 units of the TCC-EZ Total Contact Cast System because a quarantined lot may produce excessive heat.
Product
TCC-EZ, Total Contact Cast System, Model No. TCC2-4051
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1506-2018·2018-05-02
Stryker T4 Zipper Toga Sterile Garment Recall for Layer Separation
Stryker is recalling T4 Zipper Toga sterile personal protection garments because material layers may separate, creating a risk of exposure to contaminants.
Product
T4 Zipper Toga, (L/XL); Catalog Number: 0400-820-000 Sterile personal protection garment
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1476-2018·2018-05-02
Zimmer Biomet Recalls ZMS Intramedullary Fixation Smooth Guide Wires
Zimmer Biomet is recalling ZMS Intramedullary Fixation Smooth Guide Wires due to potential failure of the sterile packaging seal.
Product
ZMS Intramedullary Fixation Smooth Guide Wire Bullet Tip 3.0 mm Diameter, 100 cm Length; Item Number: 47-2237-038-00
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1133-2018·2018-05-02
Maharaja Food Importers Recalls Whole Wheat Parotta for Undeclared Milk
Maharaja Food Importers, Inc. is recalling Whole Wheat Parotta because the label lists ghee but fails to declare milk as an ingredient.
Product
WHOLE WHEAT PAROTTA, UPC: 8 70400 00092 0
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-1125-2018·2018-05-02
AdvoCare Muscle Strength Supplement Recalled for Undeclared Milk
AdvoCare International is recalling specific lots of Muscle Strength Dietary Supplement because they contain undeclared milk, a major food allergen.
Product
AdvoCare Muscle Strength Dietary Supplement with HMB and Suma Product code, P3221
Category
Food
Distribution
0 states
HighFDA (Devices)·Z-1463-2018·2018-05-02
Integra LifeSciences Recalls Humeral Stem Trials for Breakage Risk
Integra LifeSciences is recalling 1,619 humeral stem trials for the Titan Modular Shoulder System because they may break during surgery.
Product
The humeral stems trials are packaged in a kit for Titan Modular Shoulder System under the following labeling: Catalog Number Product Description TRL092002506 Humeral Stem Trial, 6mm TRL092002507 Humeral Stem Trial, 7mm TRL092002508 Humeral Stem Trial, 8mm TRL092002509 Hum
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0721-2018·2018-05-02
FDA Recalls LIPO-DEN Injectable Due to Unknown Particulate Matter
Coastal Meds, LLC. is recalling 1,309 vials of LIPO-DEN Injectable-30 mL because of the presence of unknown particulate matter.
Product
LIPO-DEN Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1509-2018·2018-05-02
Stryker T4 Zipper Toga Recall Due to Material Separation Risk
Stryker is recalling T4 Zipper Toga sterile garments because material layers may separate, creating a risk of exposure to contaminants.
Product
T4 Zipper Toga, X-Large; Catalog number: 0400-850-000 Sterile personal protection garment
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1470-2018·2018-05-02
Zimmer Biomet Recalls ZMS Intramedullary Fixation Smooth Guide Wires
Zimmer Biomet is recalling ZMS Intramedullary Fixation Smooth Guide Wires due to potential failure of the sterile packaging seal.
Product
ZMS Intramedullary Fixation Smooth Guide Wire 3.0 mm Diameter, 100 cm Length; Item Number: 47-2237-037-00
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·18E029000·2018-05-02
FiTech Fuel Injection Systems Recalled for Fuel Leak Fire Risk
Fuel Injection Technology is recalling Summit Racing Max 500-EFI systems because fuel injector O-rings may leak, increasing fire risk.
Product
FUEL SYSTEM, GASOLINE:FUEL INJECTION SYSTEM recall
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1501-2018·2018-05-02
Stryker T4 Pullover Toga Recalled for Potential Material Separation
Stryker is recalling T4 Pullover Toga sterile garments because material layers may separate, posing a risk of exposure to contaminants.
Product
T4 Pullover Toga, L/XL; Catalog Number: 0400-720-000 Sterile personal protection garment
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0725-2018·2018-05-02
Coastal Meds Recalls Methylcobalamin Injectable Due to Particulate Matter
Coastal Meds, LLC. is recalling 4,524 vials of Methylcobalamin Injectable due to the presence of unknown particulate matter.
Product
METHYLCOBALAMIN Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-1143-2018·2018-05-02
Traditional Medicinals Recalls Organic EveryDay Detox Lemon Tea for Salmonella
Traditional Medicinals is recalling specific lots of organic EveryDay Detox Lemon tea because raw material tested positive for Salmonella.
Product
Traditional Medinicals organic EveryDay Detox Lemon; Naturally Caffeine Free Herbal Tea; 16 wrapped tea bags - Herbal Supplement NET WT .85 oz (24g) UPC: 32917-00197
Category
Food
Distribution
0 states
HighFDA (Devices)·Z-1471-2018·2018-05-02
Zimmer Biomet Recalls Pressure Sentinel Guide Wires Due to Sterile Seal Failure
Zimmer Biomet is recalling 19,483 Pressure Sentinel Intramedullary Reaming System Guide Wires because the sterile packaging seal may fail, potentially compromising sterility.
Product
Pressure Sentinel Intramedullary Reaming System Guide Wire Bullet Tip 2.4 mm Diameter; Item Number: 00-2228-024-00
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1514-2018·2018-05-02
Synthes Stem Extractor Recalled Due to Potential Screw Breakage
Synthes, Inc. is recalling 31 Stem Extractor f/Guide Bar units because the connection screw may break during use.
Product
Stem Extractor f/Guide Bar, Part number 03.401.072. Instrumentation for extraction and revision of Epoca shoulder implants.
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·18E030000·2018-05-02
Ivolution Recalls IV2 HY-811 Motorcycle Helmets for Vision Blockage
Ivolution Sports Inc. is recalling IV2 HY-811 motorcycle helmets because they may block peripheral vision, increasing crash risk.
Product
EQUIPMENT:MOTORCYCLE:HELMETS recall
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1528-2018·2018-05-02
EEA Hemorrhoid Stapler Recalled for Potential Welding Defect
FDA is recalling EEA Hemorrhoid and Prolapse Stapler Sets due to a potential welding defect that could cause bleeding or anastomotic leak.
Product
EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 4.8MM, Product Number HEM3348, GTIN Number 1 - 10884521047563, GTIN Number 2 - 20884521047560 Product Usage: The EEA Hemorrhoid and prolapse stapler set with DST Series Technology (instrument) is designed f
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1507-2018·2018-05-02
Stryker T5 Zipper Toga Sterile Garment Recall for Layer Separation
Stryker is recalling T5 Zipper Toga sterile garments because material layers may separate, posing a risk of exposure to contaminants.
Product
T5 Zipper Toga with Peel-Away Face Shield, (L/XL); Catalog number: 0400-820-100 Sterile personal protection garment
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1130-2018·2018-05-02
MMRF Neyyappam Recalled for Undeclared Milk Allergen
Maharaja Food Importers is recalling frozen MMRF Neyyappam because the label lists ghee but fails to declare milk, a major allergen.
Product
MMRF Neyyappam, UPC: 870400000111, Frozen
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1504-2018·2018-05-02
Stryker Recalls T4 Pullover Toga Due to Material Separation Risk
Stryker is recalling T4 Pullover Toga sterile garments because material layers may separate, creating a potential risk of exposure to contaminants.
Product
T4 Pullover Toga, X-Large; Catalog Number: 0400-770-000 Sterile personal protection garment
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1480-2018·2018-05-02
Life Technologies Recalls Oncomine Dx Target Test Due to False Negative Risk
Life Technologies is recalling 30 units of the Oncomine Dx Target Test because a lower RNA concentration could cause false negative results for ROS1 fusion, potentially affecting patient treatment.
Product
Oncomine Dx Target Test, (Model No. A32451), Oncomine Dx Target RNA/DNA Panel (Model No. A32441). A qualitative In Vitro Diagnostic test.
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-1508-2018·2018-05-02
Stryker T4 Zipper Toga Sterile Garments Recalled for Layer Separation
Stryker is recalling T4 Zipper Toga sterile personal protection garments because material layers may separate, posing a risk of exposure to contaminants.
Product
T4 Zipper Toga, Regular; Catalog number: 0400-830-000 Sterile personal protection garment
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0720-2018·2018-05-02
Coastal Meds Recalls LIPO-B Injectable Due to Particulate Matter
Coastal Meds, LLC. is recalling LIPO-B Injectable-30 mL vials due to the presence of unknown particulate matter.
Product
LIPO-B Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-1142-2018·2018-05-02
Traditional Medicinals Recalls Lemon Echinacea Tea Due to Salmonella Risk
Traditional Medicinals is recalling specific lots of Throat Coat Lemon Echinacea tea because raw materials tested positive for Salmonella.
Product
Traditional Medicinals Throat Coat Lemon Echinacea; Lemon Echinacea, Naturally Caffeine Free Herbal Tea' 16 wrapped tea bags - Herbal Supplement NET WT 1.13 oz. (32 g) UPC: 32917-00159
Category
Food
Distribution
0 states
HighFDA (Food)·F-1124-2018·2018-05-02
AdvoCare Nighttime Recovery Supplement Recalled for Undeclared Milk
AdvoCare International is recalling 48,176 units of Nighttime Recovery Amino Acid and Herbal Dietary Supplement because the product contains undeclared milk, a major food allergen.
Product
AdvoCare Nighttime Recovery Amino Acid and Herbal Dietary Supplement Product code, P3201
Category
Food
Distribution
0 states
HighFDA (Food)·F-1128-2018·2018-05-02
Maharaja Food Importers Recalls Jack Fruit for Undeclared Milk Allergen
Maharaja Food Importers is recalling ELA ADA (Jack Fruit) because the label lists ghee but fails to declare milk, a major allergen.
Product
ELA ADA (JACK FRUIT), UPC: 8 70400 00085 2
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-1132-2018·2018-05-02
MMRF Ela Ada Jaggery Recalled for Undeclared Milk Allergen
Maharaja Food Importers is recalling frozen MMRF Ela Ada Jaggery because the label lists ghee but fails to declare milk, a major allergen.
Product
MMRF Ela Ada Jaggery, UPC: 870400000067, Frozen
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1465-2018·2018-05-02
Zimmer Biomet Recalls Humeral Guide Wires Due to Packaging Seal Failure
Zimmer Biomet is recalling 19,483 M/DN Intramedullary Fixation Humeral Guide Wires because the sterile packaging seal may fail, potentially compromising sterility.
Product
M/DN Intramedullary Fixation Humeral Guide Wire - Smooth 2.4 mm Diameter 70 cm Length Single Use Only; Item Number: 00-2255-025-00
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1503-2018·2018-05-02
Stryker T4 Pullover Toga Recall Due to Layer Separation
Stryker is recalling T4 Pullover Toga sterile garments because material layers may separate, creating a risk of exposure to contaminants.
Product
T4 Pullover Toga, Large; Catalog Number: 0400-760-000 Sterile personal protection garment
Category
Medical Device
Distribution
Distributed nationwide
HighCPSC·18148·2018-05-02
Carter's Recalls Children's Cardigan Sets Due to Choking Hazard
Carter's is recalling 3-piece penguin cardigan sets because the toggle button can detach, posing a choking hazard to young children.
Product
3-piece penguin cardigan sets
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Food)·F-1134-2018·2018-05-02
Nxtgen Botanicals Maeng Da Kratom Recalled for Salmonella Risk
NGB Corp is recalling Nxtgen Botanicals Maeng Da Kratom dietary supplements due to potential Salmonella contamination.
Product
Nxtgen Botanicals, Maeng Da Kratom, Dietary Supplement, 70 capsules
Category
Food
Distribution
Distributed nationwide
HighNHTSA·18V274000·2018-05-02
Winnebago Recalls 2018-2019 RVs Due to Roof Rack Fastener Defect
Winnebago is recalling 293 recreational vehicles because roof racks may detach due to incorrect fasteners, creating a road hazard.
Product
WINNEBAGO — WINNEBAGO REVEL, ERA, TRAVATO
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1533-2018·2018-05-02
BD Vacutainer Blood Collection Set Recalled for Sterility Assurance Failure
Becton Dickinson is recalling BD Vacutainer Ultra Touch Push Button Blood Collection Sets because they do not meet the labeled sterility assurance level.
Product
BD Vacutainer¿ Ultra TouchTM Push Button Blood Collection Set 0.6 x 19 mm x 305 mm 23G x ¿ x 12. Catalog no 367364
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1502-2018·2018-05-02
Stryker T4 Pullover Toga Recall Due to Layer Separation Risk
Stryker is recalling T4 Pullover Toga sterile garments because material layers may separate, posing a risk of exposure to contaminants.
Product
T4 Pullover Toga, Regular ; Catalog Number: 0400-750-000 Sterile personal protection garment
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0717-2018·2018-05-02
Coastal Meds Recalls Cyanocobalamin Injectable Due to Particulate Matter
Coastal Meds, LLC. is recalling 745 vials of Cyanocobalamin Injectable due to the presence of unknown particulate matter.
Product
CYANOCOBALAMIN Injectable-30 mL MDV. Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-1129-2018·2018-05-02
MMRF Kumbiliappam Recalled for Undeclared Milk Allergen
Maharaja Food Importers is recalling frozen MMRF Kumbiliappam because the label lists ghee but fails to declare milk as an ingredient.
Product
MMRF Kumbiliappam, UPC: 87040000104, Frozen
Category
Food
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1485-2018·2018-05-02
Keystone Dental Recalls Genesis Surgical Cassettes Due to Burr Wobble
Keystone Dental Inc is recalling 19 Genesis Surgical Cassettes because extra-large grommets cause dental burrs to wobble.
Product
Genesis Surgical Cassette Tapered Implants are intended for placement following natural tooth loss or for immediate placement into an extraction socket
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1522-2018·2018-05-02
Zimmer Biomet Recalls Orthopedic Salvage System Locking Collars
Zimmer Biomet is recalling Orthopedic Salvage System locking collars due to a potential dry blast irregularity on the screws.
Product
Orthopedic Salvage System (OSS) Modular Arthrodesis 0 Degree Locking Collar, Model Number CP260600 Product Usage: The replacement of segmental defects of long bone, including midshaft replacement, and arthrodesis of the knee.
Category
Medical Device
Distribution
8 states
ModerateFDA (Devices)·Z-1521-2018·2018-05-02
Cook Inc. Recalls Advance 35LP Balloon Catheters Due to Labeling Error
Cook Inc. is recalling 40 Advance 35LP Low-Profile PTA Balloon Dilatation Catheters because some units were packaged with incorrect size labels.
Product
Advance¿ 35LP Low-Profile PTA Balloon Dilatation Catheter; Catalog numbers: PTA5-35-135-6-2 .0 and PTA5-35-135-4-4 .0; UDI: 10827002522647 and 10827002522524 Product Usage: The Advance¿ 35LP Low Profile PTA Balloon Dilation Catheter is indicated for percutaneous translumin
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0694-2018·2018-05-02
Time-Cap Recalls Ibuprofen Caplets Due to Odor Complaints and CGMP Deficiencies
Time-Cap Laboratories is recalling specific lots of Ibuprofen Caplets 200 mg due to odor complaints and CGMP deficiencies. The recall covers nationwide distribution.
Product
IBUPROFEN — IBUPROFEN (IBUPROFEN)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1469-2018·2018-05-02
Zimmer Biomet Recalls Natural Nail System Guide Wires Due to Packaging Seal Failure
Zimmer Biomet is recalling 19,483 Natural Nail System Tear Drop Guide Wires because the sterile packaging seal may fail, potentially compromising sterility.
Product
Zimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter, 100 cm Length; Item Number: 47-2490-097-00
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1524-2018·2018-05-02
Zimmer GmbH Recalls Avenir Muller Stem Due to Potential Label Mismatch
Zimmer GmbH is recalling specific Avenir Muller Stem implants because a potential commingle may cause the product in the package to not match the outer label.
Product
Avenir Muller Stem; Item Number: 01.06010.003, Lot Number: 2904368, UDI: (01) 00889024479494 (17) 220331 (10) 2904368
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1529-2018·2018-05-02
Accelerate PhenoTest BC kit recalled for false positive results
Accelerate Diagnostics is recalling 95 PhenoTest BC kits because they may produce false positive results for Staphylococcus aureus.
Product
Accelerate PhenoTest BC kit, Ref #10101018. The firm name on the label is Accelerate Diagnostics, Tucson, AZ. A multiplexed in-vitro diagnostic test intended for use with the Accelerate Pheno system.
Category
Medical Device
Distribution
5 states
ModerateFDA (Devices)·Z-1496-2018·2018-05-02
Diagnostic Hybrids Recalls MicroVue CIC-C1q EIA Kits Due to Validation Concerns
Diagnostic Hybrids, Inc. is recalling 101 MicroVue CIC-C1q EIA kits because the standard curve slope may fail validation requirements.
Product
MicroVue CIC-C1q EIA, Model A001. An enzyme immunoassay for the detection of circulating immune complexes in human serum or plasma. The assay uses highly pure, functional human C1q coated in the solid phase to capture immune complexes (CIC). In the first stage, CIC in the dilut
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-1462-2018·2018-05-02
Howmedica Triathlon Revision Knee Implants Recalled for Sizing Errors
Howmedica Osteonics Corp. is recalling 77 Triathlon Revision Knee implants because customers may receive the incorrect size from what is labeled on the box.
Product
Triathlon Revision Knee Catalog #5545-A-301 and Catalog #5546-A-601 The knee system devices are sterile, single-use devices intended for us in revision total knee arthroplasty to alleviate pain and restore function.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1535-2018·2018-05-02
Heidelberg Engineering Recalls Widefield OCT Software Feature for Spectralis Devices
Heidelberg Engineering is recalling the Widefield OCT software feature for Spectralis HRA+OCT devices because FDA determined a 510(k) clearance is required before use.
Product
Widefield OCT software feature for the Spectralis HRA+OCT and variants
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1361-2018·2018-05-02
Crimson Trace Laser Sights Recalled for Exceeding Power Output Limits
Crimson Trace is recalling 184,390 laser sights for firearms because some units exceeded the 5 mW power output limit.
Product
Crimson Trace Corporation laser sights. The Finished Products are laser sighting systems for firearms, used for personal defense and target acquisition.
Category
Consumer Product
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0688-2018·2018-05-02
Time-Cap Recalls Ibuprofen Tablets Due to Odor Complaints
Time-Cap Laboratories is recalling specific lots of Ibuprofen Tablets USP 400 mg due to odor complaints related to CGMP deficiencies.
Product
Ibuprofen Tablets USP 400 mg, 500 tablet bottles (NDC 42582-111-18), Rx, Distributed by Bi-Coastal Pharma International, Shrewsbury, NJ, Manufactured by: Marksans Pharma, Ltd., Plot No. L-82, L-83 Verna indl. Estate Verna, Goa-403 722, India
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1475-2018·2018-05-02
Zimmer Biomet Recalls Intramedullary Fixation Guide Wires Due to Packaging Seal Failure
Zimmer Biomet is recalling ZMS Intramedullary Fixation Smooth Guide Wires because the sterile packaging seal may fail, potentially compromising sterility.
Product
ZMS Intramedullary Fixation Smooth Guide Wire 2.4 mm Diameter, 100 cm Length; Item Number: 47-2237-033-00
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0716-2018·2018-05-02
McKesson Recalls Diltiazem HCl Extended-Release Capsules Due to Dissolution Failures
McKesson Packaging Services is recalling Diltiazem HCl Extended-Release Capsules, 240 mg, because stability testing showed high dissolution results.
Product
Diltiazem HCl Extended-Release Capsules, USP 240 mg, 100-count bottles, Rx Only, Mfg. By: Par Pharmaceutical One Ram Ridge Rd Chestnut Ridge, NY 10977. NDC: 63739-016-10
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0686-2018·2018-05-02
Time-Cap Recalls Ibuprofen Tablets Due to Odor Complaints
Time-Cap Laboratories is recalling specific lots of ibuprofen tablets due to odor complaints linked to CGMP deficiencies.
Product
IBUPROFEN — IBUPROFEN (IBUPROFEN)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1511-2018·2018-05-02
Synthes Flex Arm Recalled for Potential Connection Failure
Synthes, Inc. is recalling 84 Flex Arm units because the quick connect feature may fail to connect to mating parts.
Product
Flex Arm Product Usage: The Synthes Flex Arm is a component of the Synthes Minimally Invasive Support System, which provides secure table mounting for minimally invasive spine surgery. The Flex Arm is designed to hold Synthes Minimally Invasive Retractors, which are connected
Category
Medical Device
Distribution
Distributed nationwide
ModerateUSDA FSIS·035-2018·2018-05-02
JBS Recalls Ground Beef Products Due to Possible Hard Plastic Contamination
JBS USA is recalling approximately 35,464 pounds of raw ground beef products that may contain hard plastic pieces. The products were distributed to retail locations in Virginia and Indiana.
Product
Swift Beef Company — JBS USA, Inc. Recalls Ground Beef Products Due to Possible Foreign Matter Contamination
Category
Food
Distribution
2 states
ModerateFDA (Drugs)·D-0692-2018·2018-05-02
Time-Cap Recalls Ibuprofen Tablets Due to Odor Complaints
Time-Cap Laboratories is recalling specific lots of Ibuprofen 800 mg tablets due to odor complaints linked to CGMP deficiencies.
Product
IBUPROFEN — IBUPROFEN (IBUPROFEN)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0690-2018·2018-05-02
Ibuprofen Tablets Recalled Due to Odor Complaints and CGMP Deficiencies
Time-Cap Laboratories is recalling specific lots of Ibuprofen Tablets USP 600 mg due to odor complaints linked to CGMP deficiencies.
Product
Ibuprofen Tablets USP 600 mg, a) 100 tablets (NDC 42582-112-10) and b) 500 tablet bottles (NDC 42582-112-18), Rx, Distributed by: Bi-Coastal Pharma International, Shrewsbury, NJ, Manufactured by: Marksans Pharma, Ltd., Plot No. L-82, L-83 Verna indl. Estate Verna, Goa-403 722, In
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0685-2018·2018-05-02
Time-Cap Recalls Ibuprofen Tablets Due to Odor Complaints
Time-Cap Laboratories is recalling various strengths of ibuprofen tablets due to odor complaints related to CGMP deficiencies.
Product
IBUPROFEN — IBUPROFEN (IBUPROFEN)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1474-2018·2018-05-02
Zimmer Biomet Recalls Humeral Guide Wires Due to Sterile Packaging Seal Failure
Zimmer Biomet is recalling 19,483 M/DN Intramedullary Fixation Humeral Guide Wires because of a potential failure of the sterile packaging seal.
Product
M/DN Intramedullary Fixation Humeral Guide Wire Bullet Tip 2.4 mm Diameter, 70 cm Length; Item Number: 00-2255-026-00
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1536-2018·2018-05-02
Smith & Nephew Whipknot Sutures Recalled for Sterile Barrier Defect
Smith & Nephew is recalling Whipknot Soft Tissue Cinch sutures because packaging design flaws may allow sterile barrier breaches.
Product
Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015
Category
Medical Device
Distribution
7 states
ModerateFDA (Drugs)·D-0687-2018·2018-05-02
Time-Cap Recalls Ibuprofen Tablets Due to Odor Complaints and CGMP Deficiencies
Time-Cap Laboratories is recalling specific lots of Ibuprofen Tablets USP 400 mg due to odor complaints related to Current Good Manufacturing Practice (CGMP) deficiencies.
Product
IBUPROFEN — IBUPROFEN (IBUPROFEN)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0715-2018·2018-05-02
McKesson Recalls Diltiazem CD Capsules Due to Dissolution Failures
McKesson Packaging Services is recalling Diltiazem CD 180 mg capsules because stability testing showed high dissolution results.
Product
Diltiazem CD (Diltiazem Hydrochloride Extended-Release Capsules, USP) 180 mg, 100-count bottles, Rx Only Mfg. By: Actavis 60 Columbia Rd., Bldg. B Morristown, NJ 07960. NDC 63739-284-10
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0691-2018·2018-05-02
Time-Cap Recalls Ibuprofen Tablets Due to Odor Complaints
Time-Cap Laboratories is recalling specific lots of Ibuprofen Tablets USP 600 mg due to odor complaints linked to CGMP deficiencies.
Product
Ibuprofen Tablets USP 600 mg, a) 100 tablet (NDC 42582-112-01), b) 500 tablet bottles (NDC 42582-112-18), Rx, Distributed by Drug Mart, Food Fair, Medina, Ohio 44256
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1519-2018·2018-05-02
Roche Acetaminophen Assay Method Sheets Missing Interference Statement
Roche Diagnostics is recalling Acetaminophen assay method sheets for COBAS INTEGRA and MODULAR ANALYTICS systems because they omit a statement regarding potential interference from gammopathy.
Product
Roche Acetaminophen assay 03255379160-HAcetaminophen (P) 20767174160- cobas c Integra AAcetaminophen150 test
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1526-2018·2018-05-02
Stryker Recalls 18 Hinge Coupling Units Due to Packaging Error
Stryker GmbH is recalling 18 Hinge Coupling Hoffmann LRF units because connecting nuts were incorrectly packed in hinge coupling packaging.
Product
Hinge Coupling Hoffmann LRF Catalog # 4933-0-800 Intended for fixation of fractures, joint contractures, fusions, limb lengthening, deformity correction, bone and soft tissue reconstruction in pediatric patients and adults.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0693-2018·2018-05-02
Time-Cap Recalls Ibuprofen Tablets Due to Odor Complaints
Time-Cap Laboratories is recalling specific lots of 800 mg ibuprofen tablets due to odor complaints linked to CGMP deficiencies.
Product
Ibuprofen Tablets USP 800 mg, a) 100 tablet (NDC 42582-113-10) and b) 500 tablet (NDC 42582-113-18) bottles, Rx, Distributed by; Bi-Coastal Pharma International, Shrewsbury, NJ, Manufactured by: Marksans Pharma, Ltd., Verna, Goa-403 722, India
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1534-2018·2018-05-02
Ethicon Recalls Evicel Fibrin Sealant Accessory Tips Due to Distribution Error
Ethicon is recalling Evicel Accessory Device 45 cm Flexible Tips because products labeled for foreign distribution may have been distributed in the US.
Product
Evicel Accessory Device - 45 cm Flexible Tip (SET OF 3), Product Code EVT45. Accessory Tips for use only with EVICEL Fibrin Sealant (Human) Application Device.
Category
Medical Device
Distribution
27 states
ModerateFDA (Devices)·Z-1512-2018·2018-05-02
Howmedica Recalls Six Knee Prosthesis Units Due to Incorrect Size Labeling
Howmedica Osteonics Corp. is recalling six sterile knee prosthesis units because the implant size may not match the box label.
Product
Knee Prosthesis, Sterile, Single-Use devices Product Usage: The knee system devices are intended for use in revision total knee arthroplasty to alleviate pain and restore function
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1499-2018·2018-05-02
Diagnostic Hybrids Recalls MicroVue SC5b-9 Plus EIA Kits Due to Bacterial Contamination
Diagnostic Hybrids, Inc. is recalling 72 MicroVue SC5b-9 Plus EIA kits because a component was found to contain bacterial contamination.
Product
MicroVue SC5b-9 Plus EIA (CE-IVD), Model A029. An enzyme immunoassay for the quantitation of SC5b-9 complex present in human plasma or serum.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0689-2018·2018-05-02
Time-Cap Recalls Ibuprofen Tablets Due to Odor Complaints
Time-Cap Laboratories is recalling specific lots of Ibuprofen 600 mg tablets due to odor complaints linked to CGMP deficiencies.
Product
IBUPROFEN — IBUPROFEN (IBUPROFEN)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1467-2018·2018-05-02
Zimmer Biomet Recalls Natural Nail System Tear Drop Guide Wires
Zimmer Biomet is recalling 19,483 Natural Nail System Tear Drop Guide Wires due to potential sterile packaging seal failures.
Product
Zimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter, 70 cm length; Item Number: 47-2490-098-00
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0712-2018·2018-05-02
Lyne Laboratories Recalls Subpotent Fluocinolone Acetonide Ear Drops
Lyne Laboratories is recalling 17,939 units of Fluocinolone Acetonide Topical Oil ear drops because the medication is subpotent.
Product
FLUOCINOLONE ACETONIDE — FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE)
Category
Drug
Distribution
0 states
ModerateFDA (Devices)·Z-1486-2018·2018-05-02
Siemens ADVIA Centaur CA 125II Assay Recalled for Over-Recovery
Siemens Healthcare Diagnostics is recalling ADVIA Centaur CA 125II Assay kits because some patient samples may exhibit over-recovery outside the provided data.
Product
ADVIA Centaur CA 125II Assay; Cat No. 09427226, SMN 10310443 (1-pack/100 tests); Cat no. 01678114, SMN 10315696 (5-pack/500 tests)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1525-2018·2018-05-02
Zimmer GmbH Recalls Avenir Muller Stem Due to Potential Label Mismatch
Zimmer GmbH is recalling Avenir Muller Stems due to a potential commingle that could result in the product not matching the outer label.
Product
Avenir Muller Stem; Item Number: 01.06010.104, Lot Number: 2905496, UDI: (01)00889024479500 (17)220430 (10)2905496
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1473-2018·2018-05-02
Zimmer Biomet Recalls Guide Wires Due to Sterile Packaging Seal Failure
Zimmer Biomet is recalling Smooth Guide Wire Bullet Tip products because the sterile packaging seal may fail, potentially compromising sterility.
Product
Smooth Guide Wire Bullet Tip 3.0 mm Diameter, 100 cm Length; Item Number: 47-2255-008-01
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1498-2018·2018-05-02
Diagnostic Hybrids Recalls MicroVue SC5b-9 Plus EIA Kits Due to Bacterial Contamination
Diagnostic Hybrids, Inc. is recalling 107 MicroVue SC5b-9 Plus EIA kits because a component was found to contain bacterial contamination.
Product
MicroVue SC5b-9 Plus EIA (RUO), Model A020. Research use only (RUO) product. An enzyme immunoassay for the quantitation of SC5b-9 complex present in human plasma or serum.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0695-2018·2018-05-02
Time-Cap Recalls Ibuprofen Caplets Due to Odor Complaints
Time-Cap Laboratories is recalling specific bottles of Ibuprofen 200 mg caplets due to odor complaints linked to CGMP deficiencies.
Product
IBUPROFEN — IBUPROFEN (IBUPROFEN)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1497-2018·2018-05-02
Diagnostic Hybrids Recalls MicroVue CIC-C1q EIA Kits Due to Bacterial Contamination
Diagnostic Hybrids, Inc. is recalling 19 MicroVue CIC-C1q EIA kits because a component was found to contain bacterial contamination.
Product
MicroVue CIC-C1q EIA, Model A001. The MicroVue CIC-C1q EIA is for detection of circulating immune complexes (CIC) in human serum or plasma. The MicroVue CIC-C1q EIA is for detection of circulating immune complexes (CIC) in human serum or plasma. In certain disease states, immu
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1530-2018·2018-05-02
Menarini Silicon Biosystems Recalls CellSearch Circulating Tumor Cell Kits
Menarini Silicon Biosystems is recalling CellSearch Circulating Tumor Cell Kits because unusually high image counts may delay result reporting.
Product
CELLSEARCH¿ CIRCULATING Tumor Cell Kits (IVD) (Product Code 7900001) CELLSEARCH¿ CIRCULATING Tumor Cell Kit is intended for the enumeration of circulating tumor cells (CTC) of the epithelial origin (CD45-, EpCAM+, cytokeratins 8, 18+, and/or 19+) in whole blood.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0711-2018·2018-05-02
Lyne Laboratories Recalls Subpotent Fluocinolone Acetonide Topical Oil
Lyne Laboratories is recalling 12,572 units of Fluocinolone Acetonide Topical Oil because the product is subpotent. The recall is voluntary and was initiated by the firm.
Product
FLUOCINOLONE ACETONIDE — FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE)
Category
Drug
Distribution
0 states
LowFDA (Devices)·Z-1515-2018·2018-05-02
CooperVision Recalls Clariti 1 Day Contact Lenses for Incorrect Expiration Date
CooperVision is recalling Clariti 1 Day contact lenses because the secondary packaging displays an incorrect expiration date.
Product
clariti 1 day/Fresh Day 90 pack (-1.00), UV Blocking, 90 silicon hydrogel, daily disposable contact lenses The Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the correction of refra
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1479-2018·2018-05-02
Medtronic DxTerity Diagnostic Catheter Recalled for Incorrect Box Labeling
Medtronic is recalling 855 units of DxTerity Diagnostic Catheters because the outer box displays an incorrect 6 French size indicator, though the catheters inside are correct.
Product
Medtronic DxTerity Diagnostic Catheter, JL 4.0, REF DXT5JL40, marked with 6F color code on box.
Category
Medical Device
Distribution
0 states
LowFDA (Food)·F-1123-2018·2018-05-02
Stewart's Shops Recalls Chocolate Peanut Butter Cup Ice Cream
Stewart's Shops Corp. is recalling 7,695 units of Chocolate Peanut Butter Cup Ice Cream in New York and Vermont due to a packaging defect.
Product
Chocolate Peanut Butter Cup Ice Cream, packaged in a 16 oz. cardboard container, UPC 082086444688
Category
Food
Distribution
2 states
LowFDA (Devices)·Z-1516-2018·2018-05-02
CooperVision Recalls Clariti 1 Day Contact Lenses for Incorrect Expiration Date
CooperVision is recalling Clariti 1 Day contact lenses because the secondary packaging displays an incorrect expiration date.
Product
clariti 1 day (-1.25) 90 pack, UV Blocking, 90 silicone hydrogel, daily disposable contact lenses The Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the correction of refractiveamet
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1520-2018·2018-05-02
Quidel MicroVue Intact PTH EIA Recalled for Potential Calibration Issues
Diagnostic Hybrids, Inc. is recalling 26 units of the Quidel MicroVue Intact PTH EIA due to a potential loss of separation between calibrators that may impact assay calibration.
Product
Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quantification of Intact Parathyroid Hormone (PTH) in serum.
Category
Medical Device
Distribution
0 states

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