DrugJan 22, 2020
Lupin Pharmaceuticals Tri-Lo-Marzia recall — FDA D-0790-2020
CGMP Deviations: Out of specification test result observed during retrospective review of blend uniformity test data.
Class IIIFDA: TerminatedLupin Pharmaceuticals Inc.
January 2020 recalls — page 5
These records include useful source details for the selected month.
DrugJan 22, 2020
Motto International Rhino 7 Platinum 30000 Capsules, in blue,orange,black background with recall — FDA D-0656-2020
Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil
Class IFDA: TerminatedMotto International Corp
DrugJan 22, 2020
Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL) recall — FDA D-0658-2020
Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)
Class IIFDA: TerminatedHikma Pharmaceuticals USA Inc.
DrugJan 22, 2020
Letco Medical Estriol USP Micronized a) 100 gm NDC 62991-2159-04 recall — FDA D-0780-2020
Subpotent
Class IIFDA: TerminatedLetco Medical LLC
DrugJan 22, 2020
McGuff Compounding Pharmacy Services Lipoic Acid Injection recall — FDA D-0802-2020
Presence of Particulate Matter: filmy/cloudy particulate observed in vial.
Class IIFDA: TerminatedMcGuff Compounding Pharmacy Services, Inc.
DrugJan 22, 2020
Testosterone Cypionate for Injection, USP, 1,000 mg/10 mL (100 mg/mL), 10 mL Multiple Dose recall — FDA D-0787-2020
cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot.
Class IIFDA: TerminatedSun Pharmaceutical Industries, Inc.
VehicleJan 17, 2020
Toyota Motor Engineering & Manufacturing air bag control module recall — NHTSA campaign 20V024000
Toyota Motor Engineering & Manufacturing (Toyota) is recalling certain 2011-2019 Corolla, 2011-2013 Matrix, 2012-2018 Avalon, and 2013-2018 Avalon Hybrid vehicles. During certain crashes,…
air bag control moduleToyota Motor Engineering & Manufacturing
Medical DeviceJan 15, 2020
Intersurgical Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy recall — FDA Z-0787-2020
The port may crack in the swivel elbow where the flip cap is inserted, and these cracks could possibly leak if they reach a significant size.
Class IIFDA: TerminatedIntersurgical Inc.
Medical DeviceJan 15, 2020
Medacta Shoulder SYSTEM HUMERAL ANATOMICAL METAPHYSIS, REF 04.01.0023 through 04.01.0055 recall — FDA Z-0775-2020
Certain lot numbers of the Medacta Humeral Anatomical Cementless Metaphysis have a dimensional condition that could limit insertion of the screw used to lock the metaphysis to the humeral…
Class IIFDA: TerminatedMedacta Usa Inc.
Medical DeviceJan 15, 2020
Baxter Healthcare ONE-LINK Needle-free IV Connector, Product Codes: 7N8300, 7N8301, 7N8310 recall — FDA Z-0794-2020
Continu-Flo sets with male Luer bodies at the lower end of, and within, the ISO specification for outer diameter require a higher than expected connection force to fully inset and securely…
Class IIFDA: OngoingBaxter Healthcare Corporation
Medical DeviceJan 15, 2020
Siemens Medical Solutions USA Cios Alpha, Model Number 10308191 recall — FDA Z-0782-2020
During a routine inspection of a system, a crack on the C-arm holder was discovered. In the event the C-arm holder has a crack, the stability of the C-arm may be compromised and could lead…
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
Medical DeviceJan 15, 2020
Cochlear Baha 5 Sound Processor Tamper Proof Battery Door (3 pcs.) recall — FDA Z-0792-2020
Product was packaged with the Incorrect tamper proof battery door.
Class IIFDA: TerminatedCochlear Americas Inc.
Medical DeviceJan 15, 2020
Abbott Medical Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF recall — FDA Z-0789-2020
Three lots of Fast-Cath Hemostasis Introducer devices contained 8F sized dilators and sheaths instead of the expected 8.5F devices.
Class IIFDA: TerminatedAbbott Medical
Medical DeviceJan 15, 2020
Abbott Medical Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303 recall — FDA Z-0783-2020
Fast-Cath Trio Hemostasis Introducer devices contained 12F sized dilators and sheaths instead of the expected 14F devices.
Class IIFDA: TerminatedAbbott Medical
Medical DeviceJan 15, 2020
Baxter Healthcare Clearlink System Continu-Flo Administration Sets, Product Codes: 2C8519 recall — FDA Z-0793-2020
Continu-Flo sets with male Luer bodies at the lower end of, and within, the ISO specification for outer diameter require a higher than expected connection force to fully inset and securely…
Class IIFDA: OngoingBaxter Healthcare Corporation
Medical DeviceJan 15, 2020
Medical convenience trays and kits, labeled as: Medical Action Industries, Inc.: ***CVC*** recall — FDA Z-0779-2020
The kits contain a bottle of saline solution which may exceed the USP specified pH requirements of 4.5-7.0.
Class IIFDA: TerminatedMedical Action Industries, Inc. 306
Medical DeviceJan 15, 2020
Stryker Pin To Rod Coupling External Fixation System Hoffmann II Compact - Pin To Rod recall — FDA Z-0781-2020
Pin To Rod Coupling could not clamp the pin and rod as intended
Class IIFDA: TerminatedStryker GmbH
Medical DeviceJan 15, 2020
Intersurgical Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF recall — FDA Z-0785-2020
The port may crack in the swivel elbow where the flip cap is inserted, and these cracks could possibly leak if they reach a significant size.
Class IIFDA: TerminatedIntersurgical Inc.
Medical DeviceJan 15, 2020
Stryker T2 Alpha Delta Strike Plate IMN Instruments - part of the IMN Instruments System and recall — FDA Z-0780-2020
Instrument can break at the level of the thread when being exposed to high forces during nail implantation or removal which can lead to complications during nail insertion and removal.
Class IIFDA: TerminatedStryker GmbH
Medical DeviceJan 15, 2020
Intersurgical Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF recall — FDA Z-0784-2020
The port may crack in the swivel elbow where the flip cap is inserted, and these cracks could possibly leak if they reach a significant size.
Class IIFDA: TerminatedIntersurgical Inc.
Medical DeviceJan 15, 2020
Intersurgical Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy recall — FDA Z-0786-2020
The port may crack in the swivel elbow where the flip cap is inserted, and these cracks could possibly leak if they reach a significant size.
Class IIFDA: TerminatedIntersurgical Inc.
Medical DeviceJan 15, 2020
Implant Direct Sybron Manufacturing ImplantDirect InterActive Precision IO Scan Adapter recall — FDA Z-0790-2020
The peek part was loose on the titanium base of the device which could result in it falling into a patient's mouth during a procedure resulting in aspiration or ingestion.
Class IIFDA: CompletedImplant Direct Sybron Manufacturing, LLC
Medical DeviceJan 15, 2020
Implant Direct Sybron Manufacturing ImplantDirect InterActive Precision IO Scan Adapter recall — FDA Z-0791-2020
The peek part was loose on the titanium base of the device which could result in it falling into a patient's mouth during a procedure resulting in aspiration or ingestion.
Class IIFDA: CompletedImplant Direct Sybron Manufacturing, LLC
Medical DeviceJan 15, 2020
Avanos Medical Haylard Closed Suction System for Neonates/Pediatrics, 5 Fr, 1 recall — FDA Z-0788-2020
Avanos Medical has received reports stating that the central lumen of some 5 Fr Neonate/Pediatric Closed Suction Catheters may be fully blocked or partially blocked. This may cause the…
Class IIFDA: TerminatedAvanos Medical, 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.