Medical DeviceMar 21, 2018
Alden HP49 Toric Daily Wear Soft contact recall — FDA Z-0987-2018
Contact lenses lack sterility assurance.
Class IIFDA: TerminatedAlden Optical
Monthly breakdown
2018 recalls by month
Select a month to review the recall records reported during that period.
December 2018285 records · 4 categoriesNovember 2018342 records · 4 categoriesOctober 2018626 records · 4 categoriesSeptember 2018393 records · 4 categoriesAugust 2018569 records · 4 categoriesJuly 2018356 records · 4 categoriesJune 2018402 records · 4 categoriesMay 2018613 records · 4 categoriesApril 2018449 records · 3 categoriesMarch 2018523 records · 3 categoriesFebruary 2018612 records · 3 categoriesJanuary 2018290 records · 3 categories
2018 recalls — page 174
Records are ordered by the best available source date.
Medical DeviceMar 21, 2018
Alden HP59 Toric Daily Wear Soft contact recall — FDA Z-0990-2018
Contact lenses lack sterility assurance.
Class IIFDA: TerminatedAlden Optical
Medical DeviceMar 21, 2018
Draegar Medical Systems INFINITY DUAL HEMO MCable Pod recall — FDA Z-0942-2018
Dual Hemo MCable Pods with Revision Index (RI) 15 and 16, which are used with the Dr¿ger Infinity Acute Care System, may permit liquid ingress inconsistent with their IPX4 rating, which…
Class IIFDA: TerminatedDraegar Medical Systems, Inc.
Medical DeviceMar 21, 2018
Stanbio Laboratory RaPET RF Latex Reagent used as a component in the following kits: RaPET recall — FDA Z-1070-2018
All patient serum samples yield a weakly positive test result.
Class IIFDA: TerminatedStanbio Laboratory, LP
Medical DeviceMar 21, 2018
Alden Optical NovaKone Daily Wear Soft contact recall — FDA Z-0981-2018
Contact lenses lack sterility assurance.
Class IIFDA: TerminatedAlden Optical
Medical DeviceMar 21, 2018
Zimmer Biomet VERSYS 7.5 INCH BEADED FC REV 13.5X190MM STRAIGHT Prosthesis, Hip recall — FDA Z-1028-2018
The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is…
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceMar 21, 2018
Arrow International AGB+ Pressure Injectable Multi- Lumen CVC Kit Product Usage: The Arrow recall — FDA Z-0998-2018
Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceMar 21, 2018
Zimmer Biomet 6.5mm x 125mm x 16mm Cannulated Screw, Item Number: 110009948 recall — FDA Z-1064-2018
One lot of 3.5mm x 24mm Cortical Locking screws is labeled as 6.5mm x 125mm x 16mm Cannulated screws.
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceMar 21, 2018
Zimmer Biomet CR POR FEM HATCP SIZE E/L SIZE F/L Knee Prosthesis recall — FDA Z-1030-2018
The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is…
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceMar 21, 2018
3M Company - Health Care Business FUTURO (TM) SPORT, QUICK STRAP ANKLE SUPPORT, REF recall — FDA Z-0945-2018
3M discovered that the Futuro" Quick Strap Ankle Brace (Cat. #47736EN) and ACE" Brand Deluxe Ankle brace (Cat. #207736) do not have the correct labeling. The products contain natural latex…
Class IIFDA: Terminated3M Company - Health Care Business
Medical DeviceMar 21, 2018
Zimmer Biomet VERSYS 6 INCH BEADED FC 14X160MM STD BODY EXT & STD NECK Prosthesis, Hip recall — FDA Z-1024-2018
The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is…
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceMar 21, 2018
Zimmer Biomet LPS OPTION FEMORAL C-L LPS OPTION FEMORAL C-R LPS OPTION FEMORAL D-L LPS recall — FDA Z-1035-2018
The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is…
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceMar 21, 2018
Arrow International ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kit Product Usage: The Arrow recall — FDA Z-1001-2018
Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceMar 21, 2018
Zimmer Biomet LPS FEM IMPLANT SZ H-R This device is indicated for patients with severe knee recall — FDA Z-1034-2018
The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is…
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceMar 21, 2018
Zimmer Biomet CPT 12/14 COCR SIZE 2 EXT prosthesis, hip, semi-constrained, metal/polymer recall — FDA Z-1018-2018
The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is…
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceMar 21, 2018
Zimmer Biomet LPS POROUS FEM IMPLANT SZ G-L LPS PRECOAT FEM IMPLANT SZ G-L This device is recall — FDA Z-1038-2018
The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is…
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceMar 21, 2018
Zimmer Biomet CR-FLEX PCT FEM C-R MINUS CR-FLEX PCT FEM D-L MINUS CR-FLEX PCT FEM D-R MINUS recall — FDA Z-1049-2018
The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is…
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceMar 21, 2018
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) recall — FDA Z-0971-2018
Certain infusion pumps may exhibit excessive wear of the pumping mechanism caused by a lack of lubrication, this could affect the occlusion of the tubing and result in over- or…
Class IIFDA: TerminatedBaxter Healthcare Corporation
Medical DeviceMar 21, 2018
Zimmer Biomet Humeral Stem 83mm(Size 17) Product Usage: Intended for primary and revision recall — FDA Z-0979-2018
Zimmer Biomet is conducting a medical device recall for two lots of Comprehensive Humeral stems. The lots were commingled during the manufacturing process and were etched with incorrect lot…
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceMar 21, 2018
Zimmer Biomet CPT 12/14 COCR REVISION SIZE 2 180MM prosthesis, hip, semi-constrained recall — FDA Z-1015-2018
The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is…
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceMar 21, 2018
Zimmer Biomet PATELLO-FEMORAL JOINT SYSTEM GENDER SOLUTIONS PATELLO-FEMORAL Osteoarthritis recall — FDA Z-1052-2018
The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is…
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceMar 21, 2018
Zimmer Biomet CR-FLEX POR FEM F-L CR-FLEX POR FEM F-R MINUS CR-FLEX POR FEM G-L This device recall — FDA Z-1048-2018
The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is…
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceMar 21, 2018
Zimmer Biomet fastener, fixation, nondegradable, soft tissue recall — FDA Z-1009-2018
It was identified that the product was not assembled correctly causing the implant shaft to shift and fall out during the opening of the device, which potentially could break the device.
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceMar 21, 2018
Hyphen BioMed ZYMUTEST HIA MonoStrip IgGAM recall — FDA Z-1063-2018
A voluntary recall is initiated for ZYMUTEST HIA lgGAM - Ref RK040D - Lot F1700415 and ZYMUTEST HIA MonoStrip lgGAM - Ref RK041D - Lot F1700416 because they may produce false positive…
Class IIFDA: TerminatedHyphen BioMed
About the 2018 recall archive
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.