February 2020 recalls

815 recalls were announced in February 2020.

What the numbers show

Critical: 88
Severe: 191
High: 354
Moderate: 163
Low: 19

Of the 815 recalls this month scored against our rubric, 11% are Critical, 23% are Severe.

Which agencies issued them

801–815 of 815

ModerateFDA (Devices)·Z-0883-2020·2020-02-05
Synthes 2.4mm Sterile Locking Screw Recall Due to Packaging Defect
Synthes is recalling 25 units of 2.4mm sterile locking screws because the inner packaging cap may open prematurely, potentially preventing the screw from being used during surgery.
Product
2.4MM TI VA LOCKING SCREW STARDRIVE 24MM STERILE, Part Number 04.210.124TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the sterile field.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0884-2020·2020-02-05
Brasseler USA Recalls Mislabelled Steinmann Pins for Bone Fracture Fixation
Brasseler USA is recalling 103 tubes of Steinmann Pins that were incorrectly labeled as threaded pins instead of smooth pins.
Product
Brasseler USA KM169-39-76 Steinmann Pin Single Diamond Smooth, Diameter 2.8 mm, Length 228 mm Product Usage: A Steinmann Pin is used for internal fixation of large bone fractures.
Category
Medical Device
Distribution
3 states
ModerateFDA (Drugs)·D-0818-2020·2020-02-05
Medical Park Pharmacy Recalls Tadalafil 20 mg Troche Due to Expired Components
MPRX, Inc. dba Medical Park Pharmacy is recalling Tadalafil 20 mg Troche because the products were compounded using expired components and have incorrect or missing lot and expiration dates.
Product
Tadalafil 20 mg Troche
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0823-2020·2020-02-05
Macleods Pharma Recalls Montelukast Sodium Chewable Tablets for Dissolution Failure
Macleods Pharma USA is recalling 10,680 bottles of Montelukast Sodium Chewable Tablets, 5 mg, because testing revealed low out-of-specification dissolution results in one lot.
Product
MONTELUKAST SODIUM — MONTELUKAST SODIUM (MONTELUKAST SODIUM)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0911-2020·2020-02-05
Collagen Matrix Recalls GIBSON Membrane Due to Incorrect Instructions
Collagen Matrix Inc is recalling 192 units of GIBSON Healthcare Membrane Extended because they may have been packaged with incorrect Instructions for Use.
Product
GIBSON Healthcare Membrane Extended, 20mm x 30mm, Reference Number 5303-324 - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; localize
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0862-2020·2020-02-05
Siemens Atellica CH 930 Analyzer Recalled for Barcode Scanning Error
Siemens is recalling 1,528 Atellica CH 930 Analyzers in 17 foreign countries because a barcode scanning error causes the system to use default values instead of specific fluid concentrations for Sodium, Potassium, and Chloride tests.
Product
Atellica CH 930 Analyzer, Siemens Material Number 11067000, Software Versions V1.19.2 or 1.20.0 The Atellica CH 930 Analyzer is an automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0873-2020·2020-02-05
Exactech Equinoxe Humeral Stem Recalled for Incorrect Label Translation
Exactech is recalling Equinoxe humeral stems because outer labels incorrectly described the standard-length implants as 'long' in non-English translations.
Product
Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 10.5mm, REF 304-22-11 - Product Usage: The Equinoxe Shoulder System is indicated for use and in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint work total or hemi-
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0872-2020·2020-02-05
Exactech Equinoxe Humeral Stem Recalled for Incorrect Label Translation
Exactech is recalling 2,910 Equinoxe humeral stems because outer labels incorrectly described the standard-length implants as 'long' in non-English translations.
Product
Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 6.5mm, REF 304-22-07 - Product Usage: The Equinoxe Shoulder System is indicated for use and in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint work total or hemi- a
Category
Medical Device
Distribution
0 states
ModerateFDA (Drugs)·D-0812-2020·2020-02-05
Progesterone 50 mg Capsules Recalled for Expired Components
MPRX, Inc. is recalling Progesterone 50 mg capsules compounded with expired components due to incorrect or missing lot and expiration dates.
Product
Progesterone 50 mg capsules
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0810-2020·2020-02-05
Medical Park Pharmacy Recalls Naltrexone Capsules Due to Labeling Errors
MPRX, Inc. dba Medical Park Pharmacy is recalling Naltrexone 4.5 mg capsules because they were compounded using expired components and have incorrect or missing lot and expiration dates.
Product
Naltrexone 4.5 mg capsule
Category
Drug
Distribution
1 state
ModerateFDA (Food)·F-0562-2020·2020-02-05
Ground Ginger Recalled for Missing Sulfite Labeling in California
H.L. Foodservice is recalling 620 lbs of ground ginger sold in California because the packages do not identify the addition of sulfites.
Product
Ground Ginger in clear plastic bags; Sold in 1 lb. and 5 lb. bags Country of Origin: India 1 lb. UPC: 0 00000 94641 4 5 lb. UPC: 0 00000 94642 1 Pack by: H.L. FoodserviceInc.
Category
Food
Distribution
1 state
LowFDA (Devices)·Z-0876-2020·2020-02-05
GE Healthcare Recalls SIGNA Pioneer MRI Systems Due to Date Errors
GE Healthcare is recalling 62 SIGNA Pioneer MRI systems because an installation issue may cause incorrect dates on medical images.
Product
SIGNA Pioneer Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
Category
Medical Device
Distribution
Distributed nationwide
SevereNHTSA·20V061000·2020-02-04
Hyundai Recalls Vehicles Due to ABS Module Fire Risk
Hyundai is recalling specific Elantra, Elantra Touring, Santa Fe, and Entourage models because moisture in the ABS module can cause an electrical short and engine compartment fire.
Product
HYUNDAI — HYUNDAI SANTA FE, ENTOURAGE, ELANTRA, ELANTRA TOURING
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·20E003000·2020-02-04
Cummins Recalls PowerDrive EV Drivetrains for Loss of Drive Power
Cummins is recalling PowerDrive EV drivetrains for school buses, step vans, and medium-duty trucks because a connector may unplug, causing sudden loss of drive power and power steering.
Product
POWER TRAIN recall
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·20T002000·2020-02-04
Goodyear Recalls Fortera HL Tires Due to Belt Separation Risk
Goodyear is recalling specific Fortera HL tires because a manufacturing issue may cause belt separation, increasing the risk of a crash.
Product
TIRES:TREAD/BELT recall
Category
Vehicle
Distribution
Distributed nationwide

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