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Showing 5381–5400 of 68218 results

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Karl Storz - Endoskope , REF: 27840KA, Nephroscope for MI... (Karl Storz Endoscopy) – various medical device product ifus c... (2024)

Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

FDAJul 23, 2024Nationwide• Karl Storz Endoscopy

Karl Storz - Endoskope , REF: 27293AA, Hopkins Telescope ... (Karl Storz Endoscopy) – various medical device product ifus c... (2024)

Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

FDAJul 23, 2024Nationwide• Karl Storz Endoscopy

Karl Storz - Endoskope , REF: 27092AMA, Hopkins Telescope... (Karl Storz Endoscopy) – various medical device product ifus c... (2024)

Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

Moderate

FDAJul 23, 2024Nationwide• Karl Storz Endoscopy

Ciprofloxacin Ophthalmic Solution (FDC) – Defective Container (2024)

Defective container: unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.

Class IIModerate

FDAJul 23, 2024Nationwide• FDC Limited

VariSoft Infusion Set, Single Use. (Unomedical A/S Osted Aholmvej 1) – specific varisofttm infusion sets wer... (2024)

Specific VariSoftTM Infusion Sets were packaged using incorrect secondary packaging (boxes) branded "Trusteel Infusion Set".

FDAJul 23, 2024Nationwide• Unomedical A/S Osted Aholmvej 1

Karl Storz - Endoskope , REF: 27093AA Hopkins Telescope 6... (Karl Storz Endoscopy) – various medical device product ifus c... (2024)

Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

FDAJul 23, 2024Nationwide• Karl Storz Endoscopy

Karl Storz - Endoskope , REF: 27295AA, Hopkins Telescope ... (Karl Storz Endoscopy) – various medical device product ifus c... (2024)

Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

FDAJul 23, 2024Nationwide• Karl Storz Endoscopy

Desflurane E_Vap.(Saf-T-Fill) used with the A9 Anesthesia... (Mindray DS USA, Inc. dba Mindray North America) – v90 electronic vaporizer anesthetic a... (2024)

V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a component within the vaporizer causing an incomplete seal in some cases. Should this issue occur, the A9 Anesthesia System will generate alarms associated with abnormal vaporizer output. If the anesthetic concentration is too high, the patient can inhale too much anesthetic agent; the patient may suffer from symptoms such as vertigo and drowsiness after the operation. In severe cases, the patient may suffer from neurological sequelae such as hypomnesia and inattention

FDAJul 22, 2024CA, GA, KY +6 more• Mindray DS USA, Inc. dba Mindray North America

SlideView VS200 slide viewer, (EVIDENT SCIENTIFIC INC) – a broken fuse inside the laser that w... (2024)

A broken fuse inside the laser that was caused by a short circuit at PIN 4 of the DOOR CTRL. This short circuit was caused by a badly positioned cable that made contact with the housing/frame and caused a short circuit and destroyed the fuse in the laser. This caused the shutter to remain in its most recent state; either in an open or closed position. Once the fuse was destroyed the shutter could not be operated.

FDAJul 22, 2024Nationwide• EVIDENT SCIENTIFIC INC

Isoflurane E_Vap.(Safety Filling adapter): used with the ... (Mindray DS USA, Inc. dba Mindray North America) – v90 electronic vaporizer anesthetic a... (2024)

V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a component within the vaporizer causing an incomplete seal in some cases. Should this issue occur, the A9 Anesthesia System will generate alarms associated with abnormal vaporizer output. If the anesthetic concentration is too high, the patient can inhale too much anesthetic agent; the patient may suffer from symptoms such as vertigo and drowsiness after the operation. In severe cases, the patient may suffer from neurological sequelae such as hypomnesia and inattention

FDAJul 22, 2024CA, GA, KY +6 more• Mindray DS USA, Inc. dba Mindray North America

Jalapeno Cornbread Muffins (Frozen Food Processors) – Unsanitary Conditions (2024)

Manufacturing without State License and in unsanitary conditions.

FDAJul 22, 2024AL, AR, LA +2 more• Frozen Food Processors, Inc.

Cornbread Muffins (Frozen Food Processors) – Unsanitary Conditions (2024)

Manufacturing without State License and in unsanitary conditions.

FDAJul 22, 2024AL, AR, LA +2 more• Frozen Food Processors, Inc.

Azelaic Acid Gel (Glenmark) – CGMP Deviation (2024)

CGMP Deviations

Class IIModerate

FDAJul 22, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Sevoflurane E_Vap.(Quik-Fil):used with the A9 Anesthesia ... (Mindray DS USA, Inc. dba Mindray North America) – v90 electronic vaporizer anesthetic a... (2024)

V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a component within the vaporizer causing an incomplete seal in some cases. Should this issue occur, the A9 Anesthesia System will generate alarms associated with abnormal vaporizer output. If the anesthetic concentration is too high, the patient can inhale too much anesthetic agent; the patient may suffer from symptoms such as vertigo and drowsiness after the operation. In severe cases, the patient may suffer from neurological sequelae such as hypomnesia and inattention

FDAJul 22, 2024CA, GA, KY +6 more• Mindray DS USA, Inc. dba Mindray North America

Sevoflurane E_Vap.(Safety Filling adapter) used with the ... (Mindray DS USA, Inc. dba Mindray North America) – v90 electronic vaporizer anesthetic a... (2024)

V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a component within the vaporizer causing an incomplete seal in some cases. Should this issue occur, the A9 Anesthesia System will generate alarms associated with abnormal vaporizer output. If the anesthetic concentration is too high, the patient can inhale too much anesthetic agent; the patient may suffer from symptoms such as vertigo and drowsiness after the operation. In severe cases, the patient may suffer from neurological sequelae such as hypomnesia and inattention

FDAJul 22, 2024CA, GA, KY +6 more• Mindray DS USA, Inc. dba Mindray North America

Everything Roll (Izzio) – Foreign Material Risk (2024)

Potential foreign material - plastic

Class IIModerate

FDAJul 20, 2024AZ, FL, IL +5 more• Izzio Artisan Bakery, LLC

Aldi Mixed Sourdough Loaf (Izzio) – Foreign Material Risk (2024)

Potential foreign material - plastic

Class IIModerate

FDAJul 20, 2024AZ, FL, IL +5 more• Izzio Artisan Bakery, LLC

Everything Sourdough (Izzio) – Foreign Material Risk (2024)

Potential foreign material - plastic

Class IIModerate

FDAJul 20, 2024AZ, FL, IL +5 more• Izzio Artisan Bakery, LLC

Chopped Cilantro with Onion (JFE Franchising) – Listeria risk (2024)

Listeria monocytogenes

FDAJul 19, 2024KY, MI, OH +1 more• JFE FRANCHISING INC

Salsa Medium/Mild (JFE Franchising) – Listeria risk (2024)

Listeria monocytogenes

FDAJul 19, 2024KY, MI, OH +1 more• JFE FRANCHISING INC

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