Medical DeviceSep 12, 2018
Alden Optical Zenlens Toric-Gas Permeable Contact lenses for Daily Wear in a 10-cc recall — FDA Z-2981-2018
Vials labeled for the prescriptions contained incorrect lenses
Class IIIFDA: TerminatedAlden Optical
27,110medical device recall records
2,329FDA Class I records
8firms with 5+ records
Zimmer Biomet, Inc.784 records
Database records
Records — page 799
27,110 detailed records are currently available in this category.
Medical DeviceSep 12, 2018
Medline Industries Art-Line Surgery Pack-LF, STERILE, 40 packs each per case recall — FDA Z-2976-2018
Multiple surgical packs were assembled with a non-sterile CHG disk labeled as BIOPATCH" (kit component #52655) attached to the outside of the sterile pack. This may pose potential risk of…
Class IIFDA: TerminatedMedline Industries, Inc.
Medical DeviceSep 12, 2018
Encore Medical Foundation Modular Femoral Stem, Part Number, 220-10-110 recall — FDA Z-2967-2018
After receipt of a product complaint for the labeling, it was determined that this device does not have FDA clearance.
Class IIFDA: TerminatedEncore Medical, Lp
Medical DeviceSep 12, 2018
Zimmer Dental Outer Package Label: Tapered Screw-Vent Implant System, 4.1mm X 10mm, 3.5mm recall — FDA Z-2963-2018
Dental implants have incorrect item/lot numbers and size on the inner package labeling. Correct item/lot numbers and size are on the outer package labeling.
Class IIFDA: TerminatedZimmer Dental Inc.
Medical DeviceSep 12, 2018
GE Medical Systems Ultrasound & Primary Care GE LOGIQ E9 ultrasound system Product Usage recall — FDA Z-2983-2018
The system side of the power cord may break and expose the electrical conductors leading to the risk of shock.
Class IIFDA: TerminatedGE Medical Systems Ultrasound & Primary Care…
Medical DeviceSep 12, 2018
Inspire II Model 3024 Implantable Pulse Generator (IPG) for Obstructive Sleep Apnea, Inspire recall — FDA Z-2969-2018
Incorrect use-by date on the device registration/patient file labels.
Class IIFDA: TerminatedInspire Medical Systems Inc.
Medical DeviceSep 12, 2018
Medline Industries PICC Tray, STERILE, 12 packs each per case recall — FDA Z-2977-2018
Multiple surgical packs were assembled with a non-sterile CHG disk labeled as BIOPATCH" (kit component #52655) attached to the outside of the sterile pack. This may pose potential risk of…
Class IIFDA: TerminatedMedline Industries, Inc.
Medical DeviceSep 12, 2018
Exactech Tibial Alignment Guide, REF 351-10-00 Vantage Fixed Ankle system components for recall — FDA Z-2966-2018
Exactech is recalling the Tibial Alignment Guide because the Global Trade Item Number (GTIN) on the device is incorrect. The GTIN on the device reads 10885862525629, when it should read…
Class IIFDA: TerminatedExactech, Inc.
Medical DeviceSep 12, 2018
Canon Medical System, USA DRAD-3000E (Radrex-i) TFP-4336W (Wireless FPD) recall — FDA Z-2964-2018
It was found when an operator performs a radiography using the wireless flat panel detector (FPD), a message window was displayed on the monitor stating image transmission was not completed…
Class IIFDA: TerminatedCanon Medical System, USA, Inc.
Medical DeviceSep 12, 2018
GE Medical Systems Ultrasound & Primary Care GE Vivid E95 ultrasound system Product The recall — FDA Z-2988-2018
The system side of the power cord may break and expose the electrical conductors leading to the risk of shock.
Class IIFDA: TerminatedGE Medical Systems Ultrasound & Primary Care…
Medical DeviceSep 12, 2018
GE Medical Systems Ultrasound & Primary Care GE Vivid 7 ultrasound system Product Usage recall — FDA Z-2989-2018
The system side of the power cord may break and expose the electrical conductors leading to the risk of shock.
Class IIFDA: TerminatedGE Medical Systems Ultrasound & Primary Care…
Medical DeviceSep 12, 2018
McKesson Cardiology Hemo, Release SW version 13.0 recall — FDA Z-2968-2018
Change Healthcare has identified an issue where, under certain circumstances, the Real Time Monitor (RTM) may not display physiological signals.
Class IIFDA: TerminatedMcKesson Israel Ltd.
Medical DeviceSep 12, 2018
Medline Industries Cardiac Insulation Pad, OPEN HEART CDS recall — FDA Z-2979-2018
Complete delivery System (CDS) # CDS984746C was assembled using a non-sterile cardiac insulation pad, Medline component number 32369. The non-sterile component (32369) was placed within the…
Class IIFDA: TerminatedMedline Industries, Inc.
Medical DeviceSep 12, 2018
Bayer Medical Care Overhead Counterpoise Systems (OCS), OCS, 580mm CEILING MOUNT, PORTEGRA2 recall — FDA Z-2962-2018
The torque wrench used on the ceiling column assembly during a recent service visit was outside of the torque specification, potentially overtightening the bolts. The overtightening of…
Class IIFDA: TerminatedBayer Medical Care, Inc.
Medical DeviceSep 12, 2018
GE Medical Systems Ultrasound & Primary Care GE Vivid E80 ultrasound system Vivid E80 / E90 recall — FDA Z-2986-2018
The system side of the power cord may break and expose the electrical conductors leading to the risk of shock.
Class IIFDA: TerminatedGE Medical Systems Ultrasound & Primary Care…
Medical DeviceSep 12, 2018
Steris AMSCO V-PRO 1, V-PRO 1 Plus, and V-PRO maX Low Temperature Sterilization Systems The recall — FDA Z-2959-2018
There is the potential for a scenario where a punctured cup of sterilant expires while the system is powered down, upon power-up the unit will not detect the expired cup of sterilant;…
Class IIFDA: TerminatedSteris Corporation
Medical DeviceSep 12, 2018
Bayer Medical Care Overhead Counterpoise Systems (OCS), OCS CONF,STD CEIL MNT, STD HORZ ARM recall — FDA Z-2960-2018
The torque wrench used on the ceiling column assembly during a recent service visit was outside of the torque specification, potentially overtightening the bolts. The overtightening of…
Class IIFDA: TerminatedBayer Medical Care, Inc.
Medical DeviceSep 12, 2018
Quasar MD Plus, Light Therapy System, packaging, box, sleeve and user manual recall — FDA Z-2974-2018
Quasar did not receive FDA clearance for claims of collagen/elastin production as stated on the packaging and in the user manuals.
Class IIFDA: TerminatedQuasar Bio-Tech, Inc.
Medical DeviceSep 12, 2018
Medline Industries Laparoscopy CDS recall — FDA Z-2978-2018
One manufacturing lot of a non-sterile pack was assembled with a non-sterile component labeled sterile (kit component #80532NS). The non-sterile component 80532NS was supposed to be placed…
Class IIFDA: TerminatedMedline Industries, Inc.
Medical DeviceSep 12, 2018
GE Medical Systems Ultrasound & Primary Care GE Vivid E9 ultrasound system Product Usage: GE recall — FDA Z-2985-2018
The system side of the power cord may break and expose the electrical conductors leading to the risk of shock.
Class IIFDA: TerminatedGE Medical Systems Ultrasound & Primary Care…
Medical DeviceSep 12, 2018
Alden Optical Zen RC Toric-Gas permeable contact lenses for Daily Wear in a 10-cc recall — FDA Z-2982-2018
Vials labeled for the prescriptions contained incorrect lenses
Class IIIFDA: TerminatedAlden Optical
Medical DeviceSep 12, 2018
Quasar Bio-Tech Baby Quasar Plus, Light Therapy System, packaging, box, sleeve and user recall — FDA Z-2973-2018
Quasar did not receive FDA clearance for claims of collagen/elastin production as stated on the packaging and in the user manuals.
Class IIFDA: TerminatedQuasar Bio-Tech, Inc.
Medical DeviceSep 12, 2018
Medline Industries LASER CDS recall — FDA Z-2980-2018
Multiple surgical packs were assembled with a non-sterile CHG applicators labeled as "ChloraPrep" (kit component numbers: 29183, 52115, 82279, and 82281). The non-sterile components 29183,…
Class IIFDA: TerminatedMedline Industries, Inc.
Medical DeviceSep 12, 2018
GE Medical Systems Ultrasound & Primary Care GE LOGIQ 9 ultrasound system Product Usage: The recall — FDA Z-2984-2018
The system side of the power cord may break and expose the electrical conductors leading to the risk of shock.
Class IIFDA: TerminatedGE Medical Systems Ultrasound & Primary Care…
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.