Medical DeviceMar 9, 2022
Microbiologics Helix Elite" Molecular Standards: Inactivated Standard recall — FDA Z-0699-2022
Real-time shelf life testing failed at 24 months
Class IIFDA: TerminatedMicrobiologics Inc.
24,239medical device recall records
2,205FDA Class I records
8firms with 5+ records
Zimmer Biomet, Inc.751 records
Database records
Records — page 448
24,239 detailed records are currently available in this category.
Medical DeviceMar 9, 2022
Microbiologics KWIK-STIK, Quality control kit for culture media, sold as: a recall — FDA Z-0712-2022
This strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Synergy. A specific lot was found susceptible to Gentamicin Synergy during in-house testing.
Class IIFDA: TerminatedMicrobiologics Inc.
Medical DeviceMar 9, 2022
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No recall — FDA Z-0659-2022
The affected lot was placed under quarantine in September 2021 due to complaints of alleged false positives, but 243 kits were erroneously released to customers in December 2021.
Class IFDA: TerminatedCELLTRION USA Inc.
Medical DeviceMar 9, 2022
Microbiologics QC Sets and Panels: KWIK-STIK recall — FDA Z-0703-2022
The Lactobacillus acidophilus negative control (item 0243 single KWIK-STIK) contained in the 8164 Cepheid Xpert GBS QC Set and 8165 Cepheid Smart GBS QC Set was found to test positive for…
Class IIFDA: TerminatedMicrobiologics Inc.
Medical DeviceMar 9, 2022
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No recall — FDA Z-0680-2022
Returned test kits were erroneously shipped to customers. The kits are intended for Research Use Only (RUO). Additional RUO test kits were shipped to customers unlikely to use them for RUO…
Class IFDA: TerminatedCELLTRION USA Inc.
Medical DeviceMar 9, 2022
Beckman Coulter AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850 recall — FDA Z-0692-2022
Lipemic interference for the Magnesium serum application failed to meet the performance claim as defined in the IFU. Use may cause a maximum positive bias up to 30.38% in low magnesium…
Class IIFDA: TerminatedBeckman Coulter Inc.
Medical DeviceMar 9, 2022
BioPro Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC LG, Part ID 17038 recall — FDA Z-0689-2022
There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the…
Class IIFDA: TerminatedBioPro, Inc.
Medical DeviceMar 9, 2022
BioPro Titanium MPJ (Toe Implant)TOE JOINT TITANIUM PC SM, Part ID 17035 recall — FDA Z-0686-2022
There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the…
Class IIFDA: TerminatedBioPro, Inc.
Medical DeviceMar 9, 2022
BioPro Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC ML, Part ID 16815 recall — FDA Z-0684-2022
There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the…
Class IIFDA: TerminatedBioPro, Inc.
Medical DeviceMar 9, 2022
K2M Everest MI XT Outer Dilator, Catalog Number 5101-90168 recall — FDA Z-0706-2022
Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting together properly during a surgical procedure. Some dilators from these lots and…
Class IIFDA: OngoingK2M, Inc.
Medical DeviceMar 9, 2022
BioPro Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MS, Part ID 17198 recall — FDA Z-0691-2022
There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the…
Class IIFDA: TerminatedBioPro, Inc.
Medical DeviceMar 9, 2022
Microbiologics QC Sets and Panels recall — FDA Z-0698-2022
Real-time shelf life testing failed at 24 months
Class IIFDA: TerminatedMicrobiologics Inc.
Medical DeviceMar 9, 2022
Lacrimedics OPAQUE Herrick Lacrimal Plugs, HP3, 0.3 mm, HP5, 0.5mm, HP7, 0.7.mm, STERILE recall — FDA Z-0708-2022
The sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise sterility.
Class IIFDA: OngoingLacrimedics Inc.
Medical DeviceMar 9, 2022
BioPro Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MD, Part ID 17036 recall — FDA Z-0687-2022
There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the…
Class IIFDA: TerminatedBioPro, Inc.
Medical DeviceMar 9, 2022
Orthosoft, Inc. dba Zimmer CAS NavitrackER Kit A: Knee, Model Number 20-8000-000-07 recall — FDA Z-0721-2022
The product was released for distribution without passing sterilization results, which could potentially lead to insufficient sterility of the product. The highest severity risk is…
Class IIFDA: OngoingOrthosoft, Inc. dba Zimmer CAS
Medical DeviceMar 9, 2022
Microbiologics LYFO-DISK, Quality control kit for culture media, sold as: LYFO-DISK recall — FDA Z-0713-2022
This strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Synergy. A specific lot was found susceptible to Gentamicin Synergy during in-house testing.
Class IIFDA: TerminatedMicrobiologics Inc.
Medical DeviceMar 9, 2022
Stryker Leibinger GmbH & Co. KG MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032 recall — FDA Z-0715-2022
Inside the packaging of one reported item a non-conforming product was found. Contrary to the design, the barrier layer was manufactured on the inferior side of the implant versus the…
Class IIFDA: TerminatedStryker Leibinger GmbH & Co. KG
Medical DeviceMar 9, 2022
Microbiologics Helix Elite" Molecular Standards: Inactivated Standard recall — FDA Z-0701-2022
Real-time shelf life testing failed at 24 months
Class IIFDA: TerminatedMicrobiologics Inc.
Medical DeviceMar 9, 2022
Shimadzu Medical Systems Digital Angiography System Shimadzu Trinias Generator Model recall — FDA Z-0655-2022
Due to the inadequate adjusting criteria in installation, the system generator on two Digital Angiography Systems, the irradiated x-ray may exceed the x-ray radiation dose rate in…
Class IIFDA: OngoingShimadzu Medical Systems
Medical DeviceMar 2, 2022
C.R. Bard BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS14C recall — FDA Z-0666-2022
There is a potential to leak from the catheter where it connects to the drain bag
Class IIFDA: TerminatedC.R. Bard Inc.
Medical DeviceMar 2, 2022
C.R. Bard BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS16C recall — FDA Z-0667-2022
There is a potential to leak from the catheter where it connects to the drain bag
Class IIFDA: TerminatedC.R. Bard Inc.
Medical DeviceMar 2, 2022
Becton Dickinson & Company BD Vacutainer Luer Lok Access Device - intended as a sterile recall — FDA Z-0665-2022
May shed contaminant particles into the urine specimen that may be misidentified as Red Blood Cells when used in conjunction with the Sysmex UF-1000i or UX-2000 Analyzers and lead to false…
Class IIIFDA: OngoingBecton Dickinson & Company
Medical DeviceMar 2, 2022
XLTEK IPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus recall — FDA Z-0661-2022
Tile kits that allow one to install and situate a video camera within a patient environment are not fitting properly in some domestic institution ceiling tile grids that have a thinner…
Class IIFDA: TerminatedNatus Neurology DBA Excel Tech., Ltd. (XLTEK)
Medical DeviceMar 2, 2022
BALT USA The Optima Coil System consists of an implantable embolization coil comprised of a recall — FDA Z-0660-2022
Due to Label/Pouch mix-up. Pouches incorrectly labeled. Incorrect shelf carton label or pouch label due to inadequate manufacturing line clearance. As a result of this labeling mix-up,…
Class IIFDA: OngoingBALT USA, LLC
How to use this medical device recall index
Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
What the database can and cannot tell you
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.