💊 Drugs Class I - Dangerous
Subpotent Drug
All Recalls
95,075 total recalls in our database
💊 Drugs Class I - Dangerous
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
💊 Drugs Class I - Dangerous
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
HYDROXOCOBALAMIN Injectable-30 mL MDV. Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532
Coastal Meds
💊 Drugs Class I - Dangerous
Presence of Particulate matter. Recall due to presence of unknown particulate matter.
CYANOCOBALAMIN Injectable-30 mL MDV. Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532
Coastal Meds
💊 Drugs Class I - Dangerous
Presence of Particulate matter. Recall due to presence of unknown particulate matter.
💊 Drugs Class I - Dangerous
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
BD Vacutainer¿ Ultra TouchTM Push Button Blood Collection Set 0.6 x 19 mm x 305 mm 23G x ¿ x 12. Catalog no 367364
Becton Dickinson & Company
🏥 Medical Devices Class I - Dangerous
Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6.
T4 Zipper Toga (S/M); Catalog Number: 0400-810-000 Sterile personal protection garment
Stryker Instruments Div. of Stryker
🏥 Medical Devices Class I - Dangerous
Separation of material layers may occur, causing a potential risk of exposure to contaminants.
🏥 Medical Devices Class I - Dangerous
Products labeled for distribution outside the United States may have been distributed to customers in the United States.
🏥 Medical Devices Class I - Dangerous
A potential commingle that could result in the product in the package not matching the product on the outer label.
M/DN Intramedullary Fixation Humeral Guide Wire Bullet Tip 2.4 mm Diameter, 70 cm Length; Item Number: 00-2255-026-00
Zimmer Biomet
🏥 Medical Devices Class I - Dangerous
Potential failure of sterile packaging seal.
T4 Zipper Toga, X-Large; Catalog number: 0400-850-000 Sterile personal protection garment
Stryker Instruments Div. of Stryker
🏥 Medical Devices Class I - Dangerous
Separation of material layers may occur, causing a potential risk of exposure to contaminants.
The secondary packaging is labeled with an incorrect expiration date.
Knee Prosthesis, Sterile, Single-Use devices Product Usage: The knee system devices are intended for use in revision total knee arthroplasty to alleviate pain and restore function
Howmedica Osteonics
🏥 Medical Devices Class I - Dangerous
Firm became aware that the specific product/lot combinations referenced above may contain the incorrect size implant from what is labeled on the box.
Widefield OCT software feature for the Spectralis HRA+OCT and variants
Heidelberg Engineering
🏥 Medical Devices Class I - Dangerous
FDA notified Heidelberg Engineering that a 510(k) clearance is needed for the SPECTRALIS Widefield OCT feature, and, on November 27, 2017, Heidelberg Engineering submitted a new 510(k) for this feature. FDA has asked Heidelberg Engineering to instruct customers not to use the Widefield OCT software feature on the SPECTRALIS device until 510(k) clearance has been obtained for this software feature.
Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quantification of Intact Parathyroid Hormone (PTH) in serum.
Diagnostic Hybrids
🏥 Medical Devices Class I - Dangerous
There may be a loss of separation between Calibrators A and B which may impact the assay calibration at the lower end of the assay.
T5 Zipper Toga with Peel-Away Face Shield, (XL/T); Catalog number: 0400-850-100 Sterile personal protection garment
Stryker Instruments Div. of Stryker
🏥 Medical Devices Class I - Dangerous
Separation of material layers may occur, causing a potential risk of exposure to contaminants.
🏥 Medical Devices Class I - Dangerous
Unusually high number of total images/unassigned events may require additional time and effort for the operator to review all the images and may cause a delay in reporting the results.
Proteus 235, ProteusPLUS or Proteus ONE produces and delivers a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
Ion Beam Applications S.A.
🏥 Medical Devices Class I - Dangerous
When switching from Pencil Beam Scanning treatment mode to Uniform Scanning treatment mode, the tuning setpoints of the scanning magnets are not always taken into account when the proton beam is requested. The mismatch between the setpoint and feedback leads to an error message. Depending on user action, two scenarios are possible: 1. The user resumes the treatment field without analyzing the cause for the error message. This may lead to under-irradiation. 2. The user reboots the Scanning Magnets Power Supply Electronic Unit. This may lead to delay in patient treatment and the patient may need to be re-aligned, which leads to an additional X-ray dose.
🏥 Medical Devices Class I - Dangerous
Potential failure of sterile packaging seal.