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Monthly recall archive

U.S. Recalls — October 2018

Complete FDA and NHTSA recall records dated in October 2018.

626recall records

4categories

Oct 3, 2018first record date

Oct 31, 2018latest record date

October 2018 recalls — page 7

These records include useful source details for the selected month.

2018 archive →

DrugOct 31, 2018

RXQ Compounding Lidocaine 1% + Epinephrine 1:100,000 (MDV) INJ SOL, 50 mL per glass vial recall — FDA D-0130-2019

Subpotent drug: During testing of the retention sample, the firm discovered that the product was sub-potent.

Class IIFDA: TerminatedRXQ Compounding LLC

DrugOct 31, 2018

Cidofovir injection 375 mg/mL (75 mg/mL) vial Injection, 5 mL vials recall — FDA D-0094-2019

Lack of Assurance of Sterility: complaints received about dried powder on the outside of the bottle

Class IIFDA: TerminatedHeritage Pharmaceuticals, Inc.

DrugOct 31, 2018

Pfizer Meropenem for Injection, USA (I.V.), 1 gram/vial, 25 vials per carton, Sterile recall — FDA D-0095-2019

Lack of assurance of sterility: loss of container integrity.

Class IIFDA: TerminatedPfizer Inc.

DrugOct 31, 2018

Valeant Pharmaceuticals Cortaid Intensive Therapy Cooling Spray (1% hydrocortisone), 2 FL OZ recall — FDA D-0084-2019

CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due to the possibility of microbial contamination. No positive results…

Class IIFDA: TerminatedValeant Pharmaceuticals North America LLC

DrugOct 31, 2018

Fluocinolone Acetonide Topical Solution, USP 0.01%, 60ml Bottle recall — FDA D-0092-2019

Failed Impurities/Degradation Specifications:Out of specification result noticed for total impurities observed during stability analysis

Class IIFDA: TerminatedLUPIN SOMERSET

DrugOct 31, 2018

Testosterone Topical Solution, 30mg/1.5mL, 110mL bottles recall — FDA D-0087-2019

Defective Container: Repetitive complaints received indicating pump not working.

Class IIIFDA: TerminatedLupin Pharmaceuticals Inc.

VehicleOct 31, 2018

Kia Forte headlights recall — NHTSA campaign 18V771000

Kia Motors America (Kia) is recalling certain 2019 Kia Forte vehicles equipped with LED headlights. The headlights may not have been manufactured with the correct low beam aiming. As such,…

headlightsKia Motors America

VehicleOct 25, 2018

Toyota 4Runner labels recall — NHTSA campaign 18V753000

Southeast Toyota Distributors, LLC (SET) is recalling certain 2017-2019 Toyota 4Runner vehicles that SET modified to be equipped with a TRD wheel package. The Gross Vehicle Weight Rating…

labelsSoutheast Toyota Distributors, LLC

Medical DeviceOct 24, 2018

Zimmer Biomet Affixus Hip Fracture Nail Right 125 13 mm x 360 mm, Item Number 814313360 recall — FDA Z-0142-2019

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceOct 24, 2018

Zimmer Biomet Affixus Hip Fracture Nail Left 125 9 mm x 320 mm, Item Number 814409320 recall — FDA Z-0147-2019

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceOct 24, 2018

Zimmer Biomet Affixus Hip Fracture Nail 125 9 mm x 165 mm, Item Number 816709165 Product recall — FDA Z-0169-2019

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceOct 24, 2018

Zimmer Biomet Affixus Hip Fracture Nail Right 125 13 mm x 300 mm, Item Number 814313300 recall — FDA Z-0141-2019

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceOct 24, 2018

Zimmer Biomet Affixus Hip Fracture Nail Left 130 9 mm x 360 mm, Item Number 814609360 recall — FDA Z-0164-2019

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceOct 24, 2018

GE Medical Systems GE Healthcare MRI Systems, Software Version 15.x or HD 16 sold under the recall — FDA Z-0112-2019

The latest on-site software version may not have been reinstalled at some sites after service activities were performed resulting in images possibly flipped left/right and/or there can be…

Class IIFDA: TerminatedGE Medical Systems, LLC

Medical DeviceOct 24, 2018

AS Software AS-OBGYN Information System version 7.824.x recall — FDA Z-0118-2019

Any change made to current ultrasound machine software or hardware upgrades, adding or modifying custom fields, or adding a new Ultrasound Machine, must be tested prior to the use in…

Class IIFDA: TerminatedAS Software, Inc.

Medical DeviceOct 24, 2018

Zimmer Biomet Affixus Hip Fracture Nail Right 125 9 mm x 300 mm, Item Number 814309300 recall — FDA Z-0124-2019

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceOct 24, 2018

Zimmer Biomet Affixus Hip Fracture Nail Right 130 11 mm x 360 mm, Item Number 814511360 recall — FDA Z-0161-2019

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceOct 24, 2018

Helena Laboratories "Free and Total Protein S ELISA Kit" Cat recall — FDA Z-0106-2019

Internal components of the Protein S ELISA Antigen Kit (Lot: 3-16-5292) were mislabeled. The Protein S Conjugate Solution is labeled as Substrate, and the Substrate is labeled as Protein S…

Class IIFDA: TerminatedHelena Laboratories, Inc.

Medical DeviceOct 24, 2018

Siemens Medical Solutions USA Biograph Horizon a) 3R, Material Number 10532746 b) 4R recall — FDA Z-0177-2019

The terminals on the plug may become loose and overheat.

Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.

Medical DeviceOct 24, 2018

Zimmer Biomet Affixus Hip Fracture Nail Left 125 9 mm x 260 mm, Item Number 814409260 recall — FDA Z-0145-2019

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceOct 24, 2018

Zimmer Biomet Affixus Hip Fracture Nail Right 125 9 mm x 440 mm, Item Number 814309440 recall — FDA Z-0129-2019

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceOct 24, 2018

Philips HeartStart FR3 Defibrillator, Model: 861388, 861389 Product Usage: The HeartStart recall — FDA Z-0175-2019

Automated external defibrillators may not fully meet IPx5 water ingress specification. The device may fail to function should water intrusion occur.

Class IIFDA: TerminatedPhilips Electronics North America Corp.

Medical DeviceOct 24, 2018

Zimmer Biomet Affixus Hip Fracture Nail Right 125 11 mm x 420 mm, Item Number 814311420 recall — FDA Z-0135-2019

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceOct 24, 2018

Zimmer Biomet Affixus Hip Fracture Nail Left 130 15 mm x 360 mm, Item Number 814615360 recall — FDA Z-0168-2019

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Class IIFDA: TerminatedZimmer Biomet, Inc.

How to use this monthly recall archive

Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.