Severity 3 of 5
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.
The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.
Covidien recalls its Auto Suture blunt tip trocar (OMS-T10BTS) due to potential seal disengagement when mesh products are used incorrectly, affecting approximately 18,048 units worldwide.
Medline is recalling alcohol swabsticks that may have weak seals potentially compromising product sterility. The defect may not be visible to users.
Medline Industries is recalling Centurion scalpel handle kits due to weak seals that may compromise sterility. Users cannot always detect the defect.
Medline is recalling Centurion STERILE #5 Laryngeal Mirrors due to weak packaging seals that may not be detectable by users. The defect could result in a breach of the product's sterility if the seal fails.
Covidien is recalling certain Signia surgical stapler reloads due to unsecured components that can cause uncontrolled articulation during use, potentially disrupting the staple line. The recall affects 3,023 units distributed worldwide.
The X-Guide Handpiece Adaptor Sleeve 1 may have a manufacturing defect causing incorrect geometry that prevents proper fit on dental handpieces. Approximately 88 units are affected.
Exactech is recalling 245 units of shoulder implants due to nonconforming packaging that lacks a required oxygen barrier layer. The devices were distributed nationwide and internationally.
Medline Industries is recalling Centurion ear speculum sets due to weak seals that could compromise sterility. The defect may not be detectable by users and could allow contamination if the seal fails.
Abbott is recalling certain myoglobin test kits because of manufacturing defects that could lead to incorrect results and delayed heart attack diagnosis.
Covidien is recalling Signia Small Diameter Curved Tip Intelligent Reload surgical stapler reloads due to potential malfunction that could disrupt the staple line during use. The affected reloads may articulate uncontrollably due to unsecured components.
Life Technologies Corporation is recalling Torrent Suite Dx Software versions 5.14 and earlier due to a cybersecurity vulnerability that could allow unauthorized access to alter instrument settings, configurations, software, or data.
Exactech is recalling 6,840 units of Equinoxe shoulder implant components because their vacuum packaging lacks the required oxygen barrier layer (EVOH). The defect could potentially allow material degradation during storage.
Terumo is recalling 20,533 cardiovascular procedure kits due to a pressure relief valve that opens at incorrect pressure (200-300 mmHg instead of 400 mmHg). The defect could cause myocardial tissue damage during cardiac surgery.
Sekeroglu Lokum Love Turkish Delight is recalled because the product contains Acid Red 18. Consumers should not consume the affected product.
Technicality Inc. is recalling Trumpet Needle Guides (Cat# TMS-200) because the ring can detach when excessive pressure is applied. Approximately 20,000 units distributed nationwide in Illinois are affected.
Exactech is recalling 7,213 units of Equinoxe REVERSE SHOULDER prosthetic liners due to nonconforming packaging. The vacuum bags lack the required oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH) specified for these devices.
MEDLINE INDUSTRIES is recalling Centurion Manual uterine dilator surgical kits due to weak seals that may breach sterility. The weak seal could allow contamination and may not be detectable by users.
Exactech is recalling 826 Equinoxe Reverse Shoulder humeral liners (Item Numbers 320-36-10 and 320-36-13) due to nonconforming packaging. The vacuum bags lack the required oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).
Covidien Auto Suture Blunt Tip Trocar devices are recalled due to potential seal disengagement when using mesh products incorrectly with the device. This malfunction risk affects surgical procedures.
Covidien is recalling approximately 11,796 Auto Suture Blunt Tip Trocar units due to potential seal disengagement when mesh products are used incorrectly with the device. The issue could occur during surgical procedures.
FDA recalls 190 units of Karl Storz grasping forceps due to inadequate evidence validating safe reprocessing and sterilization of the instruments.
Exactech, Inc. is recalling 2,077 units of Equinoxe Glenoid shoulder components due to nonconforming packaging. The affected units were packaged in vacuum bags lacking the required oxygen barrier layer.
Coloplast Manufacturing is recalling 710 ureteral dilators due to a possible breach in sterile packaging detected during facility testing. The devices are distributed across multiple US states.
The Coca-Cola Company is recalling 149 cases of Powerade Zero Fruit Punch 20oz bottles distributed in South Carolina and Florida due to the potential presence of a stainless-steel ring in the product.
Coca-Cola is recalling certain Powerade Zero Mixed Berry 20 oz bottles due to potential presence of a stainless steel ring. Affected bottles were distributed to consignees in South Carolina and Florida.