Medical DeviceJan 26, 2022
Microbiologics KWIK-STIK 2 Pack, Catalog #0894P recall — FDA Z-0511-2022
Contamination with S. epidermidis
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 455
24,239 detailed records are currently available in this category.
Medical DeviceJan 26, 2022
Siemens Medical Solutions USA 1. Sensis, material # 10764561; UDI: 04056869010137 2. Sensis recall — FDA Z-0499-2022
Software error which affects Sensis Vibe Hemo, Sensis and Sensis Vibe Combo systems with software version VD12A, which could cause possible hazard to patients, operators, or other persons…
Class IIFDA: OngoingSiemens Medical Solutions USA, Inc.
Medical DeviceJan 26, 2022
Philips Heel Snuggler, Reference # 989805603411 99047 recall — FDA Z-0507-2022
After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be…
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceJan 26, 2022
Straumann USA Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5 Article Number: 138.107 recall — FDA Z-0513-2022
Mislabeled: Carton box item 138.089- Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 has an implant with measure of 3.5x13mm; and Carton Box (138.107- Easypack Helix GM Acqua has a 3.5x8mm…
Class IIFDA: TerminatedStraumann USA LLC
Medical DeviceJan 26, 2022
Straumann USA Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental recall — FDA Z-0512-2022
Mislabeled: Carton box item 138.089- Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 has an implant with measure of 3.5x13mm; and Carton Box (138.107- Easypack Helix GM Acqua has a 3.5x8mm…
Class IIFDA: TerminatedStraumann USA LLC
Medical DeviceJan 26, 2022
Philips Infant Heel Warmers w/strap, Reference # 989805603201 1223 recall — FDA Z-0506-2022
After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be…
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceJan 26, 2022
Philips Cardinal Infant Heel Warmer, Reference # 989805617251 11470-010T recall — FDA Z-0508-2022
After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be…
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceJan 26, 2022
Konica Minolta Healthcare Americas ImagePilot Versions 1.92 and 1.93-software primarily recall — FDA Z-0500-2022
lmagePilot versions 1.92 and 1.93 paired with an AeroDR or Momentum Panel potential risk of incorrect length measurement/area calculation if incorrect power sequence is followed
Class IIFDA: TerminatedKonica Minolta Healthcare Americas, Inc.
Medical DeviceJan 26, 2022
ev3 Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-S and H1-S-INT recall — FDA Z-0451-2022
Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization.
Class IFDA: Terminatedev3 Inc.
Medical DeviceJan 26, 2022
Compass Health Brands Voyager Rollator-intended as a mechanical walker recall — FDA Z-0510-2022
Wheel spoke may crack causing the wheel to separate from the axle may result in patient injuries, including bruising and lacerations requiring stitches.
Class IIFDA: OngoingCompass Health Brands (Corporate Office)
Medical DeviceJan 19, 2022
Medtronic Custom Perfusion kits, with the following product descriptions and corresponding recall — FDA Z-0491-2022
Product is labeled as non-pyrogenic but endotoxin testing was not performed.
Class IIFDA: OngoingMedtronic Perfusion Systems
Medical DeviceJan 19, 2022
DePuy Orthopaedics GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600 recall — FDA Z-0487-2022
Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
Class IIFDA: TerminatedDePuy Orthopaedics, Inc.
Medical DeviceJan 19, 2022
DePuy Orthopaedics GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100 recall — FDA Z-0490-2022
Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
Class IIFDA: TerminatedDePuy Orthopaedics, Inc.
Medical DeviceJan 19, 2022
Technomed Europe Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile recall — FDA Z-0465-2022
There is a high risk of the blue hub detaching from the corkscrew needle, resulting the the needle remaining in the patient's scalp.
Class IIFDA: TerminatedTechnomed Europe
Medical DeviceJan 19, 2022
Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with LUC recall — FDA Z-0471-2022
(1)Start-up problem: Intermittently at start-up of the system, the communication of the control unit that manages the movement of the stand is not established; (2) Emergency stop recovery…
Class IIFDA: TerminatedPhilips North America LLC
Medical DeviceJan 19, 2022
Gentherm Medical Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number recall — FDA Z-0496-2022
This recall has been initiated to provide a labeling update with revised instruction how to operate the unit with Cold Therapy pads.
Class IIFDA: TerminatedGentherm Medical, LLC
Medical DeviceJan 19, 2022
Ohio Medical Instavac Portable Suction Pump, Constant mode recall — FDA Z-0482-2022
Increase in premature device failures
Class IIFDA: OngoingOhio Medical Corporation
Medical DeviceJan 19, 2022
DePuy Orthopaedics GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100 recall — FDA Z-0486-2022
Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
Class IIFDA: TerminatedDePuy Orthopaedics, Inc.
Medical DeviceJan 19, 2022
Ion Beam Applications S.A Proteus 235; Version: PTS-8 versions before PTS-8.7.2 recall — FDA Z-0466-2022
Proton Therapy System (PTS) software can be started in the clinical environment (clinical user) while some processes are still running in the test environment (tcs user). Initiating the…
Class IIFDA: TerminatedIon Beam Applications S.A.
Medical DeviceJan 19, 2022
DePuy Orthopaedics GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100 recall — FDA Z-0488-2022
Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
Class IIFDA: TerminatedDePuy Orthopaedics, Inc.
Medical DeviceJan 19, 2022
Canon Medical System, USA Flat Panel Detector recall — FDA Z-0492-2022
Abnormal images such as horizontal stripes may be displayed and recovery may not not be possible by restarting the system. The worst case scenario is an operator who is working without a…
Class IIFDA: OngoingCanon Medical System, USA, Inc.
Medical DeviceJan 19, 2022
PTW Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0 recall — FDA Z-0479-2022
When a measurement with a PTW detector array is performed with the software BeamAdjust 2.2 or VeriSoft 8.0, a measurement error can occur under specific conditions. This error can lead to a…
Class IIFDA: TerminatedPTW NORTH AMERICA CORPORATION
Medical DeviceJan 19, 2022
Covidien LigaSure Blunt Tip Laparoscopic Sealer/Divider, Nano-Coated, Product Number LF1837 recall — FDA Z-0495-2022
Customers reported that the device jaws were difficult to open or would not open following application on tissue. Use of a device with this potential assembly issue could result in the…
Class IIFDA: TerminatedCovidien LLC
Medical DeviceJan 19, 2022
RefleXion Medical Radiotherapy System - System Label: "*** refleXion REF RXM1000 ***" recall — FDA Z-0470-2022
Due to dose discrepancy when delivering a plan to a patient in a Non-HFS (Head First Supine) orientation specifically in Feet First Supine (FFS).
Class IIFDA: TerminatedReflexion Medical, Inc.
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.