Monitor U.S. medical device recall enforcement reports from the FDA. Review product descriptions, recall reasons, classifications, dates, recalling firms and distribution information where the FDA provides them.
22,877 detailed records are currently available in this category.
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did…
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did…
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessive moisture, resulting in potential growth of mold and/or mildew.
A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may be higher than the allowable…
Neonatal pads are experiencing reduced water flow, which may reduce or prevent water heating or cooling performance of the pads that are part of a temperature management system.
Their is the potential that Universal Clip applier may not load clip after the trigger is actuated.
Medline Bulb irrigation syringes recalled due to potential for packaging sterile barrier to be breached, and these syringes were packed inside surgical procedure packs that were…
The stent-graft inside the delivery system was the incorrect size.
Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessive moisture, resulting in potential growth of mold and/or mildew.
Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessive moisture, resulting in potential growth of mold and/or mildew.
A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may be higher than the allowable…
Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessive moisture, resulting in potential growth of mold and/or mildew.
An investigation determined that delivery of the Obsidio embolic using the aliquot technique for lower gastrointestinal bleeding embolization poses a high risk of bowel ischemia. The most…
The issue was mismatched diluent lots assembled into VITRO Chemistry Products Performance Verifier I and II. This issue has the potential to cause erroneous Quality Control (QC) results…
A non-compliant power cord may have been supplied in regions that do not utilize the Type B or Type E/F plug configurations.
Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessive moisture, resulting in potential growth of mold and/or mildew.
Japanese IFU version had slightly different language and illustrations from the English IFU, which could contribute to the tip and plate falling off. In order to maintain consistency…
Their is the potential that Universal Clip applier may not load clip after the trigger is actuated.
On 07 February 2024 Beckman Coulter made the decision to conduct a field action on Access Substrate (81906) lots: 234600, 337984, 338040, 338214, 338229, 338289, 338322, 338333, 338451,…
A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may be higher than the allowable…
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.
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.
