Class I - Dangerous
8FR 16 PVC tubes were packaged in a 6.5 FR 36 Polyurethane packs and 8FR 20 PVC tubes were packaged in an 8FR 20 Polyurethane packs
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Other Medical Devices
🏥 Medical Devices • 15,809 recalls
Class I - Dangerous
The incorrect sheath was assembled to the device so that the size 7 products received 11 cm sheaths and the size 11 product received 7 cm sheaths.
Class I - Dangerous
Complaints were received claiming the material failed to polymerize under the curing light. After investigation, it was determined that a wrong photo-initiator was used in the production batch U30755 of Helioseal Clear. This failure can lead to incomplete curing of the sealant, if mono-wave LED curing lights are used.
Class I - Dangerous
MAQUET Medical Systems USA is initiating a field action for correction of the MAQUET Extension Device (Part No 1180.19F0). The Extension Device is manufactured by Maquet GmbH, in Germany, and is a table top module for use with the Maquet MAGNUS operating table system. Maquet GmbH was made aware of a potential issue that can result in the Extension Device becoming unlocked from the table top, causing it to fall down.
Stryker, T2 Guidewire, Smooth-Tipped, 3 x 800mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Stryker Howmedica Osteonics
Class I - Dangerous
During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Stryker, Gamma3 K-Wire with Washer, 13x3.2x500 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Stryker Howmedica Osteonics
Class I - Dangerous
During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Stryker, T2 Guidewire, Ball-Tipped, 3 x 1000mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Stryker Howmedica Osteonics
Class I - Dangerous
During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Stryker, T2 Fixation K-Wire 3 x 285mm WCH coated Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Stryker Howmedica Osteonics
Class I - Dangerous
During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Stryker, T2 Guidewire, Ball-Tipped, 2.5 x 1000mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Stryker Howmedica Osteonics
Class I - Dangerous
During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Stryker, T2 Guidewire, Ball Tipped, 3 x 1250mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Stryker Howmedica Osteonics
Class I - Dangerous
During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Mammomat Inspiration with Tomosynthesis functionality
Siemens Medical Solutions USA
Class I - Dangerous
A potential system fatal error may occur during tomosynthesis reconstruction with large breasts that cover nearly the entire detector surface and with a breast thickness larger than 90 mm. The data to be processed for the tomosynthesis application can exceed the capacity of the graphical processing unit (GPU). If the fatal error message occurs, reconstruction of the data will be aborted. The syste
Stryker, T2 Guidewire, Ball-Tipped, 3x800 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Stryker Howmedica Osteonics
Class I - Dangerous
During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Stryker, T2 K-Wire, 3.2x400mm, CoCr, Recon Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Stryker Howmedica Osteonics
Class I - Dangerous
During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Stryker, T2 K-Wire 1.8 x 310 mm, Sterile Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Stryker Howmedica Osteonics
Class I - Dangerous
During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Olympus Scientific Solutions Americas Corporation ( OSSA ) Delta XRF Analyzer . This is a Analytical X-ray system
Olympus Scientific Solutions Americas
Class I - Dangerous
The Firm has discovered a Software bug.
Class I - Dangerous
Some Specify 5-6-5 and 2x8 surgical lead product labeling does not adequately distinguish between permanent surgical implant and trialing/screening use.
Stryker, Gamma Guide Pin, 4x400 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Stryker Howmedica Osteonics
Class I - Dangerous
During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Stryker, T2 K-Wire, 3x285 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Stryker Howmedica Osteonics
Class I - Dangerous
During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Class I - Dangerous
"The public reason for the recall is that the product is being recalled out of an abundance of caution due to one or more consumer complaints, which have been independently investigated and remain unconfirmed. No causal connection between the complaints and the producta¿"s proper use as instructed have been determined."
Stryker, T2 Guidewire, Smooth-Tipped, 2.2 x 800mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Stryker Howmedica Osteonics
Class I - Dangerous
During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.