Archive
478 recalls were announced in April 2024.
Of the 478 recalls this month scored against our rubric, 1% are Critical, 19% are Severe.
Which agencies issued them
Navinetics Inc. has recalled the NaviNetics Skull Anchor Key and Drill Kit (Lot 331401724) because the skull anchor key may fail to allow proper attachment of the CT localizer, preventing stereotactic imaging procedures.
The Coca-Cola Company is recalling specific lots of Powerade Mountain Berry Blast distributed in South Carolina and Florida due to the potential presence of a stainless-steel ring in some bottles.
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.
AJI MORI Chillimami Sauce (250ml bottles) is being recalled due to potential contamination with Clostridium botulinum. The recall affects 78 bottles distributed to consumers in multiple states.
Medline Industries recalls 274,410 units of Centurion and Medline branded surgical forceps kits for potentially weak seals that could compromise sterility and may not be detectable during use.
Exactech is recalling 1,970 Equinoxe Reverse Shoulder humeral liners distributed nationwide and internationally due to nonconforming packaging that lacks required oxygen barrier protection. Affected devices may have compromised sterile barriers.
IntegraDose Compounding Services LLC is recalling 187 cassettes of fentanyl citrate 2,500 mcg/50mL due to leaking bags that compromise sterility. Lot 20231020FEN-1 was distributed nationwide and expired April 17, 2024.
Stryker recalled specific lots of Infinity Resection Adjustment Blocks due to a missing internal screw that locks the medial/lateral adjustment mechanism. The defect affects 47 units used in ankle arthroplasty procedures.
Medline Industries is recalling 1,520 Centurion surgical hook kits worldwide due to weak seals that may compromise sterility. The seal defect may not be detectable by users.
Abbott GmbH is recalling ARCHITECT Anti-HCV Reagent Kit (7,219 units) due to falsely elevated test results when processed after certain other tests on the same instrument. The product was distributed nationwide.
Medline Industries is recalling 74,339 blood pressure units nationwide (models MDS4001, MDS4001LA, MDS4001PLUS) due to manufacturing non-compliance with specifications.
Exactech has recalled 591 units of Equinoxe Reverse Shoulder humeral liners because the packaging lacks a required oxygen barrier layer (EVOH). The nonconforming packaging may affect material integrity of these surgical implants.
Exactech recalls 66,646 Equinoxe Reverse Shoulder humeral liners due to nonconforming packaging lacking required oxygen barrier protection. The missing EVOH layer means units do not meet established packaging specification.
Medline M1S0179 sterile tape/pen packs may have weak seals that could compromise product sterility. The weakness may not be visible during normal inspection.
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.
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.
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.
Centurion Sterile Cotton Dental Rolls with weak seals may have compromised sterility. Affected products may allow contamination if the seal fails.
Medline Industries is recalling Centurion Clamp kits due to potential weak seals that could compromise sterility. Affected units were distributed nationwide and internationally.
Covidien recalls 44,777 Auto Suture Blunt Tip Trocars worldwide due to potential seal disengagement when mesh products are used incorrectly with the device.
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.
HP Hood is recalling Country Style Cottage Cheese 24oz due to undeclared pineapple and other ingredients. Consumers with pineapple allergies or sensitivity to listed ingredients should not consume the product.
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 Equinoxe glenoid shoulder implants were packaged with non-conforming bags lacking an oxygen barrier layer (EVOH), creating potential risk of material degradation. The Class II recall affects 180 units distributed nationwide and internationally.
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 approximately 124,863 Auto Suture Structural Balloon Trocars worldwide due to potential seal disengagement when used incorrectly with mesh products.
Glenmark Pharmaceuticals is recalling 6,528 bottles of Diltiazem Hydrochloride Extended-Release Capsules nationwide because dissolution testing found the product does not meet specifications. The FDA has classified this as a Class II recall.
Covidien is recalling 93,673 Auto Suture Blunt Tip Trocars due to potential seal disengagement when mesh products are used incorrectly. Improper use could compromise device integrity during laparoscopic procedures.
Medline's Centurion Manual surgical kits may have weak seals that fail to maintain sterility. If seals breach, microorganisms could contaminate the sterile contents, posing infection risk during surgery.
Karl Storz optical scissors (REF 115400S) are being recalled due to inadequate validation evidence for reprocessing procedures. The 27 affected units were distributed nationwide; users should contact the manufacturer for guidance.
MEDLINE INDUSTRIES is recalling Centurion 10mL sterile blood collection tubes due to weak seals that may compromise sterility and allow contamination if they fail.
Covidien Auto Suture Blunt Tip Trocar units may experience seal disengagement when mesh products are used incorrectly with the device. Healthcare facilities should discontinue use of affected units and contact Covidien for guidance.
Exactech is recalling 35 units of Equinoxe shoulder arthroplasty glenoid components because packaging lacks required oxygen barrier protection. The components were packaged in vacuum bags without Ethylene Vinyl Alcohol (EVOH) layers.
Exactech is recalling 805 Equinoxe glenoid implant components due to nonconforming vacuum packaging that lacks required oxygen barrier protection, which could affect sterility.
Sekeroglu Lokum Love Turkish Delight is recalled because the product contains Acid Red 18. Consumers should not consume the affected product.
Abbott is recalling the Alinity i Anti-HCV Reagent Kit (5110 units) due to potential false-positive test results when syphilis testing precedes the HCV test on the same instrument. Customer complaints and internal studies confirmed the interaction that may produce falsely elevated results.
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.
Karl Storz Endoscopy is recalling 147 units of the REF 723014 Uvula Retractor due to inadequate reprocessing validation. The manufacturer cannot demonstrate that current sterilization methods ensure proper device sterility.
Exactech recalls 3,648 reverse shoulder implant liners due to nonconforming packaging. Vacuum bags lack required oxygen barrier (EVOH) protection against material degradation.
Turkana Food Inc. recalls Sekeroglu Lokum Love Turkish Delight 350g because the product contains Acid Red 18, a food coloring not authorized for this use.
O&M Halyard is recalling approximately 75,000 surgical hoods mislabeled as surgical caps at the dispenser level.
X-NAV Technologies is recalling the X-Guide Handpiece Adaptor Sleeve 3 due to a manufacturing defect causing incorrect geometry that prevents proper fit. The recall affects 154 units distributed worldwide.
Exactech Equinoxe Humeral Liners used in shoulder surgery are being recalled due to nonconforming packaging. Approximately 2,806 units lack the required oxygen barrier layer in their vacuum-bag packaging.
3M is recalling 265,435 tube securement devices (REF 1500U and 1501U) due to manufacturing defects including missing or partial top film layers and incorrect device shape from excess material not properly removed.
Exactech is recalling 3,436 units of shoulder arthroplasty components due to nonconforming packaging that lacks a required oxygen barrier layer. The products may not be adequately protected against oxidative degradation.
Exactech Inc. is recalling 11,031 shoulder implant components due to nonconforming vacuum bag packaging lacking a required oxygen barrier layer. The missing Ethylene Vinyl Alcohol (EVOH) layer could allow oxygen exposure to the UHMWPE material.
Becton Dickinson recalls BD Phoenix Yeast ID Panel units (Lot 3312180) due to misplaced esculin substrate that triggers system abortion. No injuries reported.
Exactech, Inc. is recalling 24,303 units of Equinoxe Reverse Shoulder humeral liners due to nonconforming vacuum-bag packaging. The bags lack the required oxygen barrier layer, failing to meet packaging specifications.
Exactech is recalling 12,643 units of Equinoxe CAGE GLENOID shoulder implants because packaging lacks a required oxygen barrier layer. Units were vacuum-sealed without the proper Ethylene Vinyl Alcohol (EVOH) barrier.
Waiakea Hawaiian Volcanic Water is being recalled due to consumer complaints of floating particles. The recall affects 3,850 cases distributed to nine U.S. states.
Baxter Healthcare is reassessing 232 Hill-Rom PRO+ pressure relief mattresses due to identified inconsistencies in service records from a previous correction. These mattresses must be verified to confirm corrections were properly applied.
Exactech recalls 39 UHMWPE shoulder arthroplasty components due to nonconforming vacuum packaging that lacks the required oxygen barrier layer.
Exactech recalls 447 units of Equinoxe Constrained Humeral Liner due to nonconforming packaging lacking required oxygen barrier layer (EVOH). Affected units were distributed nationwide and internationally.
Exactech Inc. is recalling 6,678 shoulder glenoid implant components because they were packaged in vacuum bags lacking the required oxygen barrier layer made of Ethylene Vinyl Alcohol (EVOH).
X-Gen Pharmaceuticals is recalling 1,283 vials of Cyclophosphamide for Injection due to a Package Insert error that lists concentration as '20 mg per vial' instead of '20 mg per mL'. No illnesses have been reported.
X-Gen Pharmaceuticals recalls Cyclophosphamide for Injection due to a labeling error in the Package Insert. Section 2.3 incorrectly lists the concentration as '20 mg per vial' instead of the correct '20 mg per mL'.
Airstream is recalling 172 units of the 2024 Pottery Barn travel trailer because the rear axle weight on the Federal Certification label is incorrect, which may lead to vehicle overloading.
Keystone RV is recalling 2024 Crossroads Sunset Trail travel trailers because a window shade may contact the stove burner, increasing fire risk.
Forest River Bus is recalling specific 2018-2024 transit bus models because unsecured brake lines may be damaged by the frame rail, increasing crash risk.
Autocar is recalling 2023 Xpeditor and Xspotter vehicles because steering gears may have fewer recirculating balls than required, risking loss of steering control.
Forest River is recalling certain 2024 Coachmen Catalina and Aurora Travel Trailers due to improper routing of the distribution panel wire. The unprotected wire increases the risk of fire.
Aston Martin is recalling 2021-2024 DBX vehicles due to loose electrical cables in the battery fuse box, which may cause engine stall, loss of headlights, or loss of power steering, increasing crash risk.
Procter & Gamble is recalling about 8.2 million bags of Tide, Gain, Ace, and Ariel laundry detergent packets because the outer packaging can split open near the zipper, risking serious injury, ingestion, or skin or eye injuries—especially to children.
Excalibur Crossbow is recalling about 15,000 C2 Crank cocking aids because the plastic cocking hooks can break during use and become flying projectiles, causing impact injuries and lacerations. One consumer reportedly suffered a permanent eye injury.
Essential Medical Supply is reannouncing a recall of approximately 272,000 Endurance® Hand Bed Rails due to entrapment and asphyxiation hazards. Two additional deaths have been reported since the original 2021 recall.
Empower Brands is recalling approximately 1.6 million BLACK+DECKER Model HGS011 Easy Garment Steamers because they can expel, spray, or leak hot water during use, causing burn injuries. Consumers should stop using the steamers immediately and contact the manufacturer for a full refund.
Terex Advance is recalling 2023 Commander vehicles because steering components may not be installed correctly, increasing the risk of a crash.
Zazaba International is recalling about 430 Grão de Gente baby nests sold online from March 2023 through August 2023 due to suffocation risk and fall and entrapment hazards that violate federal infant sleep product safety standards.
Walmart is recalling about 51,750 Mainstays Electric Mini Choppers because the blade can operate unexpectedly during assembly or when not enclosed, causing cuts. Five lacerations have been reported, two requiring medical attention.
Zazaba International is recalling about 795 Grão de Gente padded crib bumper bedding sets sold online between March and August 2023 due to suffocation hazard. Infants can suffocate if they roll into the bumper, which violates the federal Safe Sleep for Babies Act of 2021.
Koala Tree Enterprises (DBA Lovey & Grink) is recalling approximately 23,720 children's two-piece pajamas and lounge dresses because they violate federal flammability regulations for children's sleepwear and pose a risk of burn injuries.
Thule is recalling about 8,640 RideAlong rear-mounted child bike seats because the harness padding can contain DecaBDE, a flame retardant, in excess of regulatory limits. DecaBDE can be toxic if ingested or if it contacts skin or eyes.
Boston Scientific is recalling 461 POLARSHEATH Steerable Sheath devices due to a manufacturing tooling error that may cause inner sheath delamination and potential fragment release during medical procedures.
Fresenius is recalling 479,978 stay-safe Luer Lock Catheter Extensions due to chemical leachables in the tubing. Healthcare providers should contact the manufacturer for replacement information.
Trader Joe's 50% Less Sodium Roasted & Salted Whole Cashews are being recalled due to potential Salmonella contamination. The recall affects 6,001 cases distributed in California, Washington, and Texas.
InfuTronix is recalling 52,328 Nimbus II Infusion Pump Systems due to potential failure modes including battery failure, system errors, drug product leakage, flow rate issues, and housing damage. The devices will no longer be available or supported after June 20, 2024.
Fresenius Medical Care is recalling 114,982 stay-safe Safe Lock Catheter Extensions due to peroxide cross-linked tubing leachables. Patients and healthcare providers are advised to discontinue use and contact the manufacturer for replacement.
Aston Martin is recalling 2021 DBX vehicles because loose fasteners on the front propeller shaft and differential may cause loss of front wheel drive or engine stall.
Great Value Honey Roasted Cashews (8.25 oz cans, UPC 0 78742 13334 8) are being recalled due to undeclared milk and coconut allergens on the packaging. Consumers with allergies to these ingredients should not consume the product.
DeRoyal Industries is recalling 134 GeoMed Custom Tracecarts distributed in Florida that contain a recalled Foley catheter component. Affected units carry specific lot numbers with expiration dates from February 2024 through May 2025.
Boston Scientific recalled 985 Obsidio Conformable Embolic coils because using the aliquot delivery technique for lower GI bleeding poses a high risk of bowel ischemia requiring major surgery.
Fresenius Medical Care is recalling 105,700 stay-safe /Luer Catheter Extension 6 in devices nationwide due to chemical leachables identified in the peroxide cross-linked tubing. FDA classified this as a Class I recall.
NRS Enterprises recalls 156 loaves of German Home Bakery Hazelnut Coffee Cake distributed in California for undeclared walnuts and Yellow #5 dye, posing allergic reaction risk.
InfuTronix is recalling Nimbus Infusion Pump Systems (Nimbus Flex, Nimbus PainPro) due to potential battery failure, system errors, drug leakage, flow rate abnormalities, and housing damage. About 52,328 units are affected nationwide.
Par Pharmaceutical is recalling Treprostinil Injection nationwide due to the presence of particulate matter. This FDA Class I recall affects 466 vials of lot 57014 distributed throughout the United States.
The FDA is recalling approximately 828,954 stay-safe Luer Lock Adapters due to chemical leachables identified in the peroxide cross-linked tubing. The nationwide recall affects all lots of Model Number 050-95003.
Fresenius is recalling 663,221 stay-safe Luer Lock catheter extension units nationwide due to chemical leachables (NDL PCBAs) identified in the tubing.
Roland Tahini 16 oz jars are being recalled due to potential Salmonella contamination. Consumers should not consume this product and should return it to the retailer or contact Roland Foods, LLC.
Sunflour Bakery Banana Nut Sweet Bread is recalled due to undeclared soy (a major allergen) and undeclared Yellow #5. Consumers with soy allergies should not consume this product.
Bolton Medical Inc. is recalling 21 RELAY PRO Thoracic Stent-Graft Systems because the stent-graft inside the delivery system is the incorrect size.
Applied Medical Resources is recalling the Epix Universal Clip Applier because the device may fail to load the surgical clip after the trigger is actuated. Units were distributed worldwide.
SCA Pharmaceuticals is recalling HYDROmorphone HCl injections due to lack of assurance of sterility. Patients who received the affected lot should contact their healthcare provider.
Bio-Rad Laboratories is recalling a diagnostic test kit due to incorrect calibrations and controls that may produce inaccurate test results. Patients and healthcare providers should contact the manufacturer.
Emergency Products & Research is recalling 190,000 O.T.D. traction splints because adhesive may fail to secure the pole insert, potentially compromising function in emergency medical situations.
Olympus Corporation recalls the SOLTIVE Pro SuperPulsed Laser (TFL-SLS) due to a non-compliant power cord with incompatible plug configurations for the regions where affected units were distributed.
SCA Pharmaceuticals is recalling Phenylephrine HCl injections nationwide affecting approximately 33,000 units due to lack of assurance of sterility.
Certain lots of Thermalon Back Wrap may have been exposed to excessive moisture, potentially resulting in mold and mildew growth. The product is distributed nationwide in the US and Canada.
SCA Pharmaceuticals recalls Succinylcholine Chloride 200 mg/10mL injectable due to lack of assured sterility. The recall affects 8,755 syringes distributed nationwide.
SCA Pharmaceuticals is recalling 130 cassettes of a fentanyl-bupivacaine epidural injection distributed nationwide due to lack of assurance of sterility.
SCA Pharmaceuticals recalled approximately 8,050 syringes of PHENYLephrine HCl injection nationwide due to lack of assured sterility. Affected lots have expiration dates from November 2023 to June 2024.
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