Archive
833 recalls were announced in February 2018.
Of the 833 recalls this month scored against our rubric, 3% are Critical, 27% are Severe.
Which agencies issued them
Chrysler is recalling 2018 RAM ProMaster City vehicles because tire placards may list the wrong occupant limit, risking tire failure and crashes.
ABH Nature's Products is recalling Arthri-D 120ct bottles because they may be contaminated with Salmonella. The product was distributed directly to Massachusetts and Pennsylvania.
Magno Humphries Laboratories is recalling Senna Laxative tablets that were mislabeled and contained Naproxen Sodium instead.
The Compounding Pharmacy of America is recalling 5 vials of HCG and Methylcobalamin injection due to non-sterility. The product was distributed in Tennessee and South Carolina.
A & A Finest is recalling approximately 572 pounds of frozen pork and shrimp dumplings because the product contains egg, a known allergen, which is not declared on the label.
Primus Pharmaceuticals is recalling 7,826 bottles of Limbrel (flavocoxid 250 mg) capsules because the product was marketed without an approved NDA or ANDA.
Sage Products is recalling Q.Care Oral Cleansing Systems because they were manufactured on equipment shared with non-pharmaceutical products, posing a cross-contamination risk.
Forest River is recalling 2018 Crossfit vehicles because water can corrode wiring in the tow module, potentially causing an electrical short, fire, or crash.
Sage Products Inc. is recalling the Q Care Oral Cleansing & Suctioning System because it was manufactured on equipment shared with non-pharmaceutical products, posing a cross-contamination risk.
Brolite Products Inc is recalling 1,160 bags of Bread Flavor R due to potential contamination with metal fragments from a yeast ingredient.
Sage Products is recalling Toothette Oral Care Single Use Systems because they were manufactured on equipment shared with non-pharmaceutical products.
Sage Products Inc. is recalling 852 cases of Oral Cleaning and Suctioning System q2 because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Primus Pharmaceuticals is recalling 4,006 bottles of Limbrel250 capsules because the product was marketed without an approved NDA or ANDA, meaning its safety and efficacy have not been established.
Sage Products is recalling 25 cases of Q Care RX Petite Oral Cleansing & Suctioning Systems because they were manufactured on equipment shared with non-pharmaceutical products.
Sage Products Inc. is recalling Toothette Oral Care Suction Toothbrushes with Perox-A-Mint solution because they were manufactured on equipment shared with non-pharmaceutical products.
Sage Products Inc. is recalling 2,199 cases of Oral Cleansing & Suctioning System q4 because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Sage Products Inc. is recalling Toothette Suction Toothbrush kits because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Sage Products Inc. is recalling Toothette Oral Care Short-Term Oral Swab Systems because they were manufactured on equipment shared with non-pharmaceutical products, posing a cross-contamination risk.
Sage Products Inc. is recalling Toothette Oral Care Single Use Systems because they were manufactured on equipment shared with non-pharmaceutical products, posing a cross-contamination risk.
Sage Products Inc. is recalling Q.Care Oral Cleansing & Suctioning Systems because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Sage Products Inc. is recalling Q.Care Oral Cleansing & Suctioning Systems because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Sage Products Inc. is recalling Q CARE q4 Oral Cleansing & Suctioning Systems because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Sage Products Inc. is recalling Q.Care Oral Cleansing & Suctioning Systems because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Sage Products Inc is recalling Oral Cleansing & Suctioning Systems with 0.12% Chlorexidine Gluconate Oral Rinse because they were manufactured on equipment shared with non-pharmaceutical products.
PharMEDium Services, LLC is recalling 24 bags of Oxytocin Injection due to a lack of assurance of sterility and potential endotoxin issues.
ABH Nature's Products, Inc. is recalling Zero for Him 150 count bottles due to potential Salmonella contamination. The product was distributed directly to Massachusetts and Pennsylvania.
Sage Products Inc. is recalling Q CARE q2 Oral Cleansing & Suctioning Systems because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Primus Pharmaceuticals is recalling Limbrel (flavocoxid 500 mg) capsules because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
Sage Products is recalling Q Care RX Oral Systems because they were manufactured on equipment shared with non-pharmaceutical products, posing a cross-contamination risk.
Sage Products is recalling Q CARE q4 Oral Cleansing & Suctioning Systems because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Primus Pharmaceuticals is recalling Limbrel500 capsules because they were marketed without FDA approval, meaning their safety and efficacy have not been established.
Sage Products is recalling 94 cases of Independent Care System Corinz oral care kits because they were manufactured on equipment shared with non-pharmaceutical products.
Sanofi Genzyme is recalling Synvisc-One injections due to contamination with Methylbacterium thiocyanatum. The recall affects 12,380 units distributed in 36 states.
Sage Products Inc. is recalling Toothette Oral Care Suction Swab Systems due to cross-contamination with non-pharmaceutical products during manufacturing.
Sage Products Inc. is recalling Q.Care Oral Cleansing & Suctioning Systems because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
PharMEDium Services, LLC is recalling 500 syringes of Phenylephrine HCl Injection due to a lack of assurance of sterility and potential endotoxin issues.
Sage Products Inc. is recalling the Toothette Oral Care Suction Swab System due to cross-contamination with non-pharmaceutical products during manufacturing.
PharMEDium Services, LLC is recalling 21 cassettes of 0.2% Ropivacaine HCI due to a failure to follow proper testing procedures, raising concerns about sterility and endotoxin levels.
Aesculap is recalling 13 units of the NS357R Vega PS Tibia Trial/Preparation Plateau size T4 due to incorrect labeling. Using the wrong size could lead to implantation errors, ligament injury, pain, or revision surgery.
C.R. Bard is recalling 343 CritiCore monitors because they may experience urine output and temperature measurement fluctuations and alarm errors.
Hologic is recalling 103 Panther Fusion instruments because the glass panel may separate from the monitor and fall, potentially striking an operator.
Brolite Products Inc is recalling Sponge and Dough products due to potential contamination with metal fragments from a yeast ingredient.
Weis Markets is recalling Dried Beef Party Rye Dip because the label fails to list egg and milk, which are present in the ingredients.
Yayi is recalling Hampton Bay outdoor gas fire pit tables sold at Home Depot because the bowl base lacks a heat shield, posing a burn risk.
GE Medical Systems is recalling 5,148 Carestation 600 Series anesthesia machines due to a possible incomplete seal between the CO2 absorber and the breathing circuit.
Little Rapids Corporation is recalling Graham Medical SnugFit Expandable Mattress Covers because material defects may cause the cover to tear during lifting, posing a fall risk.
Cepheid is recalling specific batches of Xpert CT/NG tests due to reports of higher-than-expected temperature drift errors and an occasional probability of false negative results.
Cost Plus World Market is recalling bleeding drip taper candles because their high flames can ignite the wax, posing a fire hazard.
Roche Diabetes Care is recalling the Accu-Chek Connect app because a software bug may cause incorrect unit changes, risking inaccurate blood glucose data or carbohydrate input.
Hanover Foods is recalling 180,900 lbs of frozen sliced squash found positive for Listeria monocytogenes. The product was distributed in Pennsylvania.
Exactech is recalling 41 GPS Total Shoulder Application 3.2mm Vix Bits because they may fracture during use.
Kalila Medical is recalling 99 Vado Steerable Sheaths because internal testing detected torn liner material at the proximal end, potentially caused by manufacturing damage.
Cincinnati Sub-Zero is recalling 1,355 Hemotherm units to provide updated instructions for cleaning and disinfection to address NTM infection risks.
GE Medical Systems is recalling Carestation 600 Series anesthesia machines due to a possible incomplete seal between the CO2 absorber and breathing circuit.
Zimmer Biomet is recalling 11 AGC 2000 LP Patella knee implants because they were over-molded, causing the outside diameter to not match the required specifications.
Zimmer Biomet is recalling 1,275 Persona Partial Knee System instruments because the impactor pad may fracture during use.
Sage Products is recalling 1,182 Q.Care Oral Cleansing & Suctioning System kits because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
B. Braun Medical is recalling 700 Perifix Single Dose Epidural Anesthesia Trays because they contain loose polypropylene foreign matter above release specifications.
3M is recalling Bair Hugger Normothermia System blankets due to a design change that may cause unintended airflow occlusion and limited inflation.
3M is recalling Bair Hugger warming blankets because a design change may cause airflow blockage, leading to limited inflation during use.
Kalila Medical is recalling 261 Vado Bi-Directional Steerable Sheaths because torn liner material was detected during internal testing, potentially caused by manufacturing damage.
Zimmer Biomet is recalling 28 AGC 2000 LP Patella knee implants because they were over-molded, leaving the outside diameter nonconforming to the print dimension.
Smiths Medical is recalling one custom tracheostomy device that was shipped without required sterilization. The device was distributed to a customer in Germany.
Triple T Specialty Meats is recalling approximately 20,630 pounds of ready-to-eat chicken salad sold at Fareway stores in five states due to possible Salmonella Typhimurium contamination.
Zimmer Biomet is recalling BlockAid Cut Resistant Surgical Glove Liners because the product lacks sterility assurance. The recall affects 1,863 units distributed in 29 states and three countries.
Zimmer Biomet is recalling 8 units of G7 Dual Mobility Liners because they are labeled as 44mm but may physically be 42mm liners.
Brolite Products Inc is recalling 50-lb bags of #6600 TJ Tortillas due to potential metal fragment contamination from a yeast ingredient.
Cook Inc. is recalling 25 Central Venous Catheter Trays because they may not fit over the guide wire, potentially causing procedure delays.
Medtronic is recalling two units of the ANGLED DRILL (REF 6630902) because the drill tip extension is longer than the printed specification indicates.
Sage Products Inc. is recalling 835 cases of Toothette Oral Care Short Term Oral Swab Systems because they were manufactured on equipment shared with non-pharmaceutical products.
Sage Products Inc. is recalling QCare Oral Cleansing and Suctioning Systems with Corinz due to cross-contamination with non-pharmaceutical products during manufacturing.
Sage Products Inc. is recalling Toothette Oral Care Antiseptic Oral Rinse because it was manufactured on equipment shared with non-pharmaceutical products.
Keystone Dental Inc is recalling 20 units of Multi-Unit Abutments because they are unable to accept the final abutment screw.
Sage Products Inc. is recalling Toothette Oral Care Daily Oral Cleansing Kits because they were manufactured on equipment shared with non-pharmaceutical products.
Improper Goods is recalling Hibiscus Lavender Syrup because production records showed the internal fill temperature was below 165°F.
B. Braun Medical is recalling Perifix Epidural Anesthesia Trays because they contain needles with loose polypropylene foreign matter above release specifications.
B. Braun Medical is recalling Perifix Continuous Epidural Anesthesia Trays because they contain needles with loose polypropylene foreign matter.
Sage Products Inc. is recalling Toothette Oral Care Perox-A-Mint solution because it was manufactured on equipment shared with non-pharmaceutical products, posing a cross-contamination risk.
Sage Products Inc. is recalling Toothette Oral Care Q Care & Suctioning Systems because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Teva Pharmaceuticals USA is voluntarily recalling Fluoxetine Tablets USP, 10 mg, because routine stability testing revealed an out-of-specification lactoside impurity.
American Health Packaging is recalling 270 cartons of Aripiprazole Tablets, USP, 10 mg, because the active pharmaceutical ingredient did not meet all intended specifications.
B. Braun Medical is recalling Spinal & Epidural Anesthesia Trays because they contain needles with loose polypropylene foreign matter above release specifications.
Cook Inc. is recalling 75 central venous catheter sets because they may not fit over a guide wire, potentially causing procedure delays.
Sage Products is recalling Q Care Continue Care kits because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Zimmer Surgical Inc is recalling 8,231 A.T.S. 4000TS Tourniquet Systems to update on-device labels and operator manuals, and to reduce the required separation distance from RF communication equipment.
Sage Products Inc. is recalling the Toothette Short Term Oral Swab System because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Walnut Creek Foods is recalling Caramel Popcorn because the label failed to list soy lecithin as an ingredient.
Cook Inc. is recalling 85 Central Venous Catheter Sets because they may not fit over a guide wire, potentially causing procedure delays.
Aesculap Implant Systems LLC is recalling 167 units of the ELAN 4 Air System because they were released to the market before receiving FDA 510(k) clearance.
Sage Products Inc. is recalling Oral Cleansing & Suctioning Systems because they were manufactured on equipment shared with non-pharmaceutical products, posing a cross-contamination risk.
Arrow International is recalling specific PICC catheter kits because they may contain the wrong catheter size or lumen configuration, potentially delaying patient treatment.
Sage Products Inc. is recalling Toothette Oral Care Suction Swabs because they were manufactured on equipment shared with non-pharmaceutical products.
Aesculap Implant Systems LLC is recalling ELAN 4 drill accessories because they were marketed without required FDA premarket notification clearance.
Synthes USA is recalling 5 units of Norian Drillable Inject because kit expiration dates do not align with the earliest component expiration dates.
Sage Products Inc. is recalling Toothette Oral Care Suction Toothbrushes due to cross-contamination with non-pharmaceutical products during manufacturing.
Siemens is recalling Artis one fluoroscopic X-ray systems because the monitor display may blink or show a blue/black screen.
Improper Goods is recalling Lemon Ginger Syrup because the internal fill temperature was not recorded. The product was distributed in nine states.
General Mills is recalling Larabar Chocolate Chip Cookie Dough bars because they may contain individually wrapped Coconut Cream Pie Bars.
Sage Products Inc is recalling Q.Care Oral Cleansing & Suctioning Systems because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Sage Products Inc. is recalling Q Care Continue Care kits because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
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