Medical DeviceMar 17, 2021
SUNSTAR G.U.M. HYDRAL DRY MOUTH RELIEF On-the-go Oral Spray, 2 FL.OZ. UPC0 70942 30713 0 recall — FDA Z-1182-2021
The product may be contaminated with Burkholderia cepacia
Class IIFDA: TerminatedSunstar Americas, Inc.
24,725medical device recall records
2,223FDA Class I records
8firms with 5+ records
Zimmer Biomet, Inc.757 records
Database records
Records — page 521
24,725 detailed records are currently available in this category.
Medical DeviceMar 17, 2021
RTI Surgical CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 32mm Material recall — FDA Z-1214-2021
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Class IIFDA: OngoingRTI Surgical, Inc. (dba Pioneer Surgical Technology,…
Medical DeviceMar 17, 2021
RTI Surgical CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 16mm Material recall — FDA Z-1207-2021
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Class IIFDA: OngoingRTI Surgical, Inc. (dba Pioneer Surgical Technology,…
Medical DeviceMar 17, 2021
RTI Surgical CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 105mm Material recall — FDA Z-1237-2021
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Class IIFDA: OngoingRTI Surgical, Inc. (dba Pioneer Surgical Technology,…
Medical DeviceMar 17, 2021
Brainlab AG ExacTrac Dynamic recall — FDA Z-1185-2021
In case of a failed automatic marker detection, a software error causes parts of the display to incorrectly behave as if the current patient position is within predefined tolerances and may…
Class IIFDA: TerminatedBrainlab AG
Medical DeviceMar 17, 2021
Howmedica Osteonics Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented recall — FDA Z-1186-2021
Stryker has discovered that the internal profile of the Triathlon Tritanium Tibial Component (Baseplate), size 4, is potentially oversized. Due to a manufacturing issue in Lot Number…
Class IIFDA: TerminatedHowmedica Osteonics Corp.
Medical DeviceMar 10, 2021
Johnson & Johnson Surgical Vision TECNIS Toric 1-Piece IOL recall — FDA Z-1163-2021
Due to the release of nonconforming Intraocular Lenses (IOLs).
Class IIFDA: TerminatedJohnson & Johnson Surgical Vision Inc.
Medical DeviceMar 10, 2021
G & H Wire Company Band, Elastic, Orthodontic - Product Usage: Orthodontic elastics, also recall — FDA Z-1164-2021
The text on the patient pack is correct and the product itself remains unchanged. FlexMedics does not expect device failures; Instead, there is an opportunity for misuse of the device if…
Class IIFDA: TerminatedG & H Wire Company
Medical DeviceMar 10, 2021
Bovie Medical ConMed Disposable Bipolar Ablators - Product Usage: intended to be used for recall — FDA Z-1155-2021
There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current package configuration.
Class IIFDA: OngoingBovie Medical Corporation
Medical DeviceMar 10, 2021
Boston Scientific Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy recall — FDA Z-1168-2021
Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceMar 10, 2021
Siemens Medical Solutions USA Sensis / Sensis Vibe systems with software version VD12 and recall — FDA Z-1173-2021
System may sporadically freeze (lock-up) during operation or while being in an idle state, no longer possible to interact with the system
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
Medical DeviceMar 10, 2021
ReNovo Various reprocessed products: PROVISION, Reprocessed Smith and Nephew Arthroscopic recall — FDA Z-1159-2021
Non-sterile product was shipped to customers labelled as sterile.
Class IIFDA: OngoingReNovo, Inc.
Medical DeviceMar 10, 2021
HAMILTON HEATER SHAKER, 115 VAC/ 230 VAC, 750 VA, Power Consumption 41V/ 100W (max.) recall — FDA Z-1156-2021
There is a risk that the device can start a fire if flammable liquids contact and enter the device.
Class IIFDA: OngoingHamilton Co
Medical DeviceMar 10, 2021
Bovie Medical Velocity Disposable Bipolar Ablators - Product Usage: intended to be used for recall — FDA Z-1153-2021
There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current package configuration.
Class IIFDA: OngoingBovie Medical Corporation
Medical DeviceMar 10, 2021
Boston Scientific Captivator/Captiflex/Sensation Short Throw Single-Use Polypectomy Snares recall — FDA Z-1170-2021
Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceMar 10, 2021
BioFire Diagnostics Gram-Negative Bacteria And Associated Resistance Markers recall — FDA Z-1157-2021
The firm has identified an increased risk of false positive Pseudomonas aeruginosa when BCID/BCID2 Panels are used with specific BD BACTEC" blood culture vials.
Class IIFDA: TerminatedBioFire Diagnostics, LLC
Medical DeviceMar 10, 2021
Baxter Healthcare The PrisMax System Version II Hemodialysis Delivery System: Automatic recall — FDA Z-1151-2021
Variability in the performance of the tubing in the ARPS (Automatic Repositioning System) Pump Assembly which may lead to alarm situations during system self-test and therapy. This tubing…
Class IIFDA: TerminatedBaxter Healthcare Corporation
Medical DeviceMar 10, 2021
BioFire BCID2 Panel recall — FDA Z-1158-2021
The firm has identified an increased risk of false positive Pseudomonas aeruginosa when BCID/BCID2 Panels are used with specific BD BACTEC" blood culture vials.
Class IIFDA: TerminatedBioFire Diagnostics, LLC
Medical DeviceMar 10, 2021
Shanghai United Imaging Healthcare Co Digitial Medica X-ray Imagining System, Model: uDR recall — FDA Z-1160-2021
There is a potential for the X-Ray tube head (Touch screen interface) to perform an uncommanded motion. This could result in a collision with the patient.
Class IIFDA: TerminatedShanghai United Imaging Healthcare Co., Ltd.
Medical DeviceMar 10, 2021
Boston Scientific Captivator II Single-Use Polypectomy Snares Outer box UPN, Inner Pouch recall — FDA Z-1169-2021
Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceMar 10, 2021
Nihon Kohden WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI: ORG recall — FDA Z-1162-2021
Incorrect Date Stamp or No Data Transfer on Telemetry Receiver and Transmitter.
Class IIFDA: OngoingNihon Kohden America Inc.
Medical DeviceMar 10, 2021
Bovie Medical HNM Disposable Bipolar Ablators - Product Usage: intended to be used for recall — FDA Z-1154-2021
There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current package configuration.
Class IIFDA: OngoingBovie Medical Corporation
Medical DeviceMar 10, 2021
CooperSurgical Milex Gellhorn Flexible under the following labels: 1) Gellhorn Flexible recall — FDA Z-1152-2021
The affected Milex Gellhorn pessaries were incorrectly manufactured with a long stem (2.170 ), instead of a short stem (1.670 or 1.960 nominal height) as required. The length discrepancy…
Class IIFDA: TerminatedCooperSurgical, Inc.
Medical DeviceMar 10, 2021
ACIST Kodama Intravascular Ultrasound Catheter The Kodama Intravascular Ultrasound Catheter recall — FDA Z-1161-2021
Test results from the manufacturing line found a piece of damaged o-ring in an unexpected section of the catheter. Further testing indicated that pieces (>200 micron) of damaged o-ring had…
Class IFDA: TerminatedAcist Medical Systems
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.