Medical DeviceMar 21, 2018
Alden Classic 38 Sphere Daily Wear Soft contact recall — FDA Z-0983-2018
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 175
Records are ordered by the best available source date.
Medical DeviceMar 21, 2018
Hyphen BioMed ZYMUTEST HIA IgGAM recall — FDA Z-1062-2018
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
Medical DeviceMar 21, 2018
Zimmer Biomet CR-FLEX GSF PCT SZ C-R MINUS CR-FLEX GSF PCT SZ D-L MINUS CR-FLEX GSF PCT SZ recall — FDA Z-1058-2018
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 GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM FEMORAL COMPONENT N-K FLX GSM POR recall — FDA Z-1061-2018
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 VERSYS 10 INCH BEADED FC REV 13.5X250MM BWD LT and RT VERSYS BEADED FULLCOAT recall — FDA Z-1020-2018
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 OPT FEM C-L CR-FLEX OPT FEM C-R CR-FLEX OPT FEM D-L CR-FLEX OPT FEM recall — FDA Z-1047-2018
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 LCCK FEM IMPLANT SZ C-L LCCK FEM IMPLANT SZ C-R LCCK FEM IMPLANT SZ D-R LCCK recall — FDA Z-1037-2018
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 PLUS Pressure Injectable Quad- Lumen CVC Kit Product recall — FDA Z-1005-2018
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 VERSYS 6 INCH BEADED FC 12X160MM LM BODY EXT NECK VERSYS BEADED FULLCOAT recall — FDA Z-1022-2018
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
Medtronic Minimally Invasive Therapies Group Argyle Suction Tubing (Product # 8888301515) recall — FDA Z-0936-2018
Incorrect packaging. In one lot of Argyle Suction Tubing, the pouch may be incorrectly labeled as the Salem Sump Dual Lumen Stomach Tube. This product may have been distributed within the…
Class IIFDA: TerminatedMedtronic Minimally Invasive Therapies Group
Medical DeviceMar 21, 2018
Zimmer Biomet CR-FLX POR HATCP FEM C-L MINUS CR-FLX POR HATCP FEM C-R MINUS CR-FLX POR HATCP recall — FDA Z-1031-2018
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 VERSYS 7.5 IN BEADED FC +10 CALCAR 13.5X180MM STR +10 CALCAR 15.5X180MM STR recall — FDA Z-1027-2018
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
Laerdal Medical LCSU 4, Laerdal Compact Suction Unit The LCSU 4 is a portable, electrically recall — FDA Z-0973-2018
A shipment of LCSU 4 suction units and canisters attempted importation into the United States but was refused by FDA for lack of necessary approvals with CDRH by the foreign firms.
Class IIFDA: TerminatedLaerdal Medical Corporation
Medical DeviceMar 21, 2018
Zimmer Biomet VERSYS 6 INCH BEADED FC 15X160MM STD BODY STD NECK Prosthesis, Hip recall — FDA Z-1025-2018
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 VERSYS 8 INCH BEADED FC 12X200MM STR STD BODY/NECK 13X200MM STR STD BODY/NECK recall — FDA Z-1029-2018
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-FLEX PRECOAT FEMORAL B-R LPS-FLEX PRECOAT FEMORAL C-L LPS-FLEX PRECOAT recall — FDA Z-1044-2018
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 PRECOAT FEM COMP SIZE BMR CR PRECOAT FEM COMP SIZE C/R CR PRECOAT FEM COMP recall — FDA Z-1041-2018
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 BIPOLAR METAL SHELL 48 MM OD Use of the MultiPolar Bipolar Cup is indicated recall — FDA Z-1014-2018
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 36MM COCR MODULAR HD -6MM recall — FDA Z-1008-2018
One piece from a different lot mixed with lot 236840 and is incorrectly etched as -6MM offset instead of +3MM offset. As the incorrect etching and related size difference affects the…
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceMar 21, 2018
ORTHO SOLUTIONS SYSTEM 26. Part Numbers: OS900035-NS; OS900036-NS; OS900037-NS; OS900038-NS recall — FDA Z-0967-2018
Following the identification of corrosion residue found inside the cannulated devices in Forefoot and Midfoot trays Orhto Solutions Group has taken the decision to recall ALL x106 System 26…
Class IIFDA: TerminatedORTHO SOLUTIONS, LTD.
Medical DeviceMar 21, 2018
Zimmer Biomet FEM PRC LT M/RT L SML FEM PRC RT M/LT L SML FEM PRC LT M/RT L SML+ FEM PRC RT recall — FDA Z-1055-2018
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-FLEX GSF OPT SZ C-L LPS-FLEX GSF OPT SZ C-R LPS-FLEX GSF OPT SZ D-L recall — FDA Z-1056-2018
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
Stryker CMI recall — FDA Z-0974-2018
The recalled products were shipped without the required temperature control packaging, therefore could potentially have been exposed to elevated temperatures during transit.
Class IIFDA: OngoingStryker Corporation
Medical DeviceMar 21, 2018
Ion Beam Applications S.A Proteus 235, Pencil Beam Scanning, PTS-9.4.X, PTS-10.0.1.1 The recall — FDA Z-0943-2018
The internal configuration of the electrometers and the Real-Time control boards of the Dekimo Scanning Controller is not checked before each patient treatment.
Class IIFDA: TerminatedIon Beam Applications S.A.
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.