All Recalls

95,083 total recalls in our database

Medtronic Sofamor Danek USA

🏥 Medical Devices Class I - Dangerous

Product packaging may incorrectly include two bevel-tipped needles or two trocar-tipped needles instead of one diamond-tipped needle and one bevel-tipped needle.

Apr 13, 2017 Surgical Instruments View Details →

MEDHOT MTI 2000 THERMAL IMAGING SYSTEM - TotalVision software with Elevated Body Temperature Screening module, for use as a medical diagnostic purposes as part of a telethermographic system utilizing FLIR cameras, Models A615sc and A315sc. Cameras are private labeled as MAX Basic, MAX 76 and MAX 307.

Med-Hot Thermal Imaging

🏥 Medical Devices Class I - Dangerous

Indications for use are not cleared or approved for market in the U.S.

Jan 14, 2017 Diagnostic Equipment View Details →

Medi-Therm Hyper/Hypothermia System, MTA7900

Stryker Medical Division of Stryker

🏥 Medical Devices Class I - Dangerous

The water may reheat too quickly if the unit is in "Automatic" mode, switched to "Manual" mode to view water temperature, and then switched back to "Automatic" mode.

Mar 29, 2017 Other Medical Devices Nationwide View Details →

Healon 5 Pro, Part No. 10270015

Abbott Medical Optics Inc. (AMO)

🏥 Medical Devices Class I - Dangerous

Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process.

Apr 1, 2017 Other Medical Devices View Details →

Healon, Part No. 10290953, 10295210, 10200011, 10200012, 10201012, 10203012, 10213012, 10223012, 10290701, 10294751, 10295701

Abbott Medical Optics Inc. (AMO)

🏥 Medical Devices Class I - Dangerous

Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process.

Apr 1, 2017 Other Medical Devices View Details →

Regenerex Patella RGX 3 PEG SER A PATELLA 28MM RGX 3 PEG SER A PATELLA 31MM RGX 3 PEG SER A PATELLA 34MM RGX 3 PEG SER A PATELLA 37MM Product Usage: The Regenerex Series A Patella can be used for any non-cemented resurfaced 3-peg patella application within the Vanguard Complete Knee System. 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. 2. Correction of varus, valgus, or posttraumatic deformity. 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

Zimmer Biomet

🏥 Medical Devices Class I - Dangerous

pegs shearing post-operatively

Mar 22, 2017 Implants & Prosthetics Nationwide View Details →

Sample probes associated with: cobas 6000 Series System, cobas 8000 Modular Analyzer Series, cobas c 311 analyzer cobas c 501/502 cobas c 701/702 cobas 8000 ISE Product Usage: The cobas 6000 series is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. It is optimized for high throughput workloads in the professional environment using a combination of Ion selective electrodes (ISE), a photometric analysis unit an immunoassay analysis module. The cobas 8000 Modular Analyzer Series is a fully automated system for Clinical chemistry analysis, intended for the in vitro qualitative and quantitative determination of analytes in body fluids. It is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes (ISE) and a photometric analysis unit. The cobas c 311 analyzer is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests. Analytes are measured photometrically or turbidimetrically; the analyzer also has an optional ISE module for measuring sodium, potassium and chloride.

Roche Diagnostics

🏥 Medical Devices Class I - Dangerous

Due to a design change in 2015, corrosion on the sample probe electrical contacts can occur and lead to a disturbance of the sample liquid level detection (LLD). When disturbance of the sample liquid level detection (LLD) occurs, the affected sample probe may dip into the sample material deeper than intended. This may lead to carryover and medical risk cannot be excluded.

Mar 21, 2017 Diagnostic Equipment Nationwide View Details →

Microfil Composite Instruments are packaged in an unsealed plastic sleeve, which is then placed in a cardboard box. Microfil Composite Instruments are intended to be sterilized by the dentist prior to each use. It is used for composite restoration development. The thin paddles shape light-cured composites. Paddles slide under the gum line to shape the margin. The flat ends contour the surfaces of the teeth and the thin edge is used to create esthetic highlights. Models: #96041 Gold Microfil #96042 Green Microfil #96043 Blue Microfil #96044 Set of 3 Microfil (Gold, Green, Blue)

Almore International

🏥 Medical Devices Class I - Dangerous

Microfil Composite Instruments were distributed with a sterile symbol on their packaging label inserts, indicating that the products are sold as sterile devices. These products are not sterile and they are intended to be sterile prior to each use.

Apr 20, 2017 Surgical Instruments Nationwide View Details →

Healon Duet, Part No. 10290080, 10220010, 10220011 and 10220012

Abbott Medical Optics Inc. (AMO)

🏥 Medical Devices Class I - Dangerous

Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process.

Apr 1, 2017 Other Medical Devices View Details →

PERI-LOC VOLAR DISTAL RADIUS - RIGHT 3H STD HEAD LOCKING PLATE, 62 MM LENGTH, SST PLATE, REF 71823114, QTY: (1) NON-STERILE, Rx only, Smith & nephew, Inc., Memphis TN 38116

Smith & Nephew

🏥 Medical Devices Class I - Dangerous

This lot of left plates were laser etched and packaged as right plates.

Mar 22, 2017 Other Medical Devices View Details →

Healon V, Part No. 10290045

Abbott Medical Optics Inc. (AMO)

🏥 Medical Devices Class I - Dangerous

Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process.

Apr 1, 2017 Other Medical Devices View Details →

Anthrex PEEK SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-Punching

Arthrex

🏥 Medical Devices Class I - Dangerous

Some eyelets broke from SwiveLock Anchor on insertion.

Mar 24, 2017 Infusion Pumps Nationwide View Details →

Bone Dowell Harvest Tubes

Zimmer Biomet

🏥 Medical Devices Class I - Dangerous

mislabeled as 8mm tube but it is actually 9 mm in size. A 9mm subcomponent was erroneously substituted and etched as 8mm for the actual 8mm subcomponent part.

Apr 12, 2017 Other Medical Devices View Details →

CooperSurgical lnflatoball Latex Rubber Pessary sold as an individual unit and also part of the lnflatoball Pessary Kit. Product Usage: The lnflatoball Pessary is a single-patient use pessary manufactured from natural latex rubber and is used for treating cystocele and/or rectocele associated with procidentia or prolapse. The inflatoball Pessary contains one (1) Pessary in a double-pocketed sealed clear plastic pouch, one pocket containing the Pessary and one pocket containing the Instructions for Use (IFU).

CooperSurgical

🏥 Medical Devices Class I - Dangerous

The current secondary packaging, a box, incorrectly states that the product is latex free. The product is made with 100% latex. The label on the package that contains the product and the Instructions for Use (IFU) correctly states that the pessary is manufactured from latex rubber.

Apr 10, 2017 Surgical Instruments Nationwide View Details →