Archive
601 recalls were announced in October 2024.
Of the 601 recalls this month scored against our rubric, 1% are Critical, 14% are Severe.
Which agencies issued them
Datascope Corp. is recalling the CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP globally due to software defects risking hemodynamic instability and clinical data transmission failure.
Boston Scientific is recalling WallFlex and Agile Esophageal Stent Systems due to the potential for delivery catheter tip detachment. The recall affects 39 units distributed worldwide.
Philips is recalling 63 units of the Ingenia Ambition X MRI scanner due to loose screws in the IRF carrier assembly that may block the imaging tabletop and potentially delay diagnosis.
Avole, Inc. is recalling Bacalaitos Criollos Codfish Frying Mix (7 oz.) distributed in Puerto Rico because fish allergen is not declared on the product label.
Boston Scientific Corporation is recalling WallFlex Esophageal Stent Systems and Agile Esophageal Over-the-Wire Stent Systems due to potential delivery catheter tip detachment during insertion procedures.
CooperSurgical is recalling Origio Sperm Wash Medium due to low sodium pyruvate concentration that could compromise sperm cell development. This affects 980 units distributed worldwide, including throughout the US.
Authentik Fudge is recalling Montreal Fudge brand Chocolate Fudge with Nuts due to potential mold contamination. The affected products were distributed through TJ Maxx and Marshalls locations.
American Contract Systems, Inc. is recalling the Hand Pack AKHD97C medical convenience kit because an inoperable chart recorder caused humidity readings to fall outside specifications, preventing confirmation of sterilization assurance.
Philips is recalling approximately 545 IntelliVue Patient Monitor units with a broken ground bolt that may cause loss of electrical grounding, potentially affecting the device's electromagnetic immunity and emission.
54th St Blackened Sauce is being recalled because soy allergen is present in the product but missing from the label's Contains statement. Consumers with soy allergies should not consume it.
Siemens ACUSON Redwood ultrasound systems may display measurements 10 times smaller than actual if operators change the software from factory defaults to milliliters per second or minute. This could lead to misdiagnosis and poor patient management.
American Contract Systems recalls 360 units of Endovascular AAA Pack due to inability to confirm sterilization requirements were met. An inoperable chart recorder prevented verification that environmental conditions during sterilization met required specifications.
Karl Storz is recalling 78 endoscopes because their instructions for use contain reprocessing modalities that have not been reviewed or approved by the FDA.
American Contract Systems is recalling 93 units of Endovascular AAA Packs due to inability to confirm sterilization assurance requirements were met following an environmental monitoring failure.
The Ingenia Elition X MRI device may have loose screws that interfere with the horizontal tabletop, potentially delaying patient diagnosis and causing anxiety during extended bore exposure.
Cook Biotech is recalling 8 units of Biodesign Recto-Vaginal Fistula Plug devices because they expire before the date printed on the label. The affected products may lose sterility if used after actual expiration.
American Contract Systems is recalling 60 Shoulder SESH18I medical convenience kits nationwide due to equipment failure that resulted in out-of-specification humidity readings, preventing sterilization assurance confirmation.
Custodiol HTK Solution is subject to a Class II recall due to the potential for particles in the solution. The affected product consists of 48 cartons distributed in North Carolina.
Boston Scientific is recalling Agile Esophageal Stent Systems due to potential delivery catheter tip detachment. The Class II recall affects 6 units distributed worldwide.
Philips is recalling the Ingenia Elition X MRI device due to loose screws in the RF carrier assembly that could block the tabletop and delay diagnosis or cause patient anxiety.
Cook Biotech is recalling 35 units of Biodesign Fistula Plug surgical implants that expire before their printed expiration dates, potentially compromising device function.
Karl Storz Hopkins Telescope 6 endoscopes (59 units, nationwide) are recalled because their reprocessing instructions lack FDA review and approval for safety and efficacy.
Cook Biotech is recalling the Biodesign Fistula Plug implant because devices expire before their labeled expiration dates. Thirty-nine units distributed worldwide are affected.
Fujifilm mobile x-ray systems may fail to apply configured exposure settings or default to adult chest imaging parameters. This could result in inappropriate radiation exposure levels.
Cook Biotech is recalling Biodesign Fistula Plug C-FPB-0.4 implants because products expire before their printed expiration dates.
Boston Scientific is recalling WallFlex and Agile esophageal stent systems due to potential delivery catheter tip detachment during stent placement procedures.
Boston Scientific is recalling WallFlex and Agile Esophageal Stent Systems for potential delivery catheter tip detachment during insertion. Eighteen units were distributed worldwide including the United States.
American Contract Systems recalled 280 units of its Day Surgery General Pack due to humidity control failures that prevent confirmation of adequate sterilization.
Cook Biotech is recalling Biodesign Fistula Plug C-FPS-0.2-2 implants because affected units expire before their labeled expiration dates. The defect could compromise product performance.
Merit Medical Systems is recalling 1,892 Prelude Sheath Introducer devices due to a labeling error: devices labeled as 7.5F are actually sized as 7F. The dimensional mislabeling could result in incorrect device selection during medical procedures.
American Contract Systems is recalling 66 ENT medical convenience kits because humidity readings were out of specification, preventing confirmation of sterilization.
CooperSurgical is recalling Origio Sperm Wash Medium because low sodium pyruvate levels could compromise gamete development.
American Contract Systems is recalling 48 Arthroscopy Packs because humidity readings were out of specification, preventing confirmation of sterilization.
The FDA is recalling LINK Universal Handles due to risk of material failure when first used. The surgical instrument may break during surgery, compromising patient safety.
Cook Biotech is recalling 3 units of Biodesign Recto-Vaginal Fistula Plug RVP-0.2 because the devices expire prior to the expiration date printed on the labeling.
Argon Medical Devices recalls BioPince Ultra and Tru-Core II biopsy instruments due to holes in packaging trays compromising the sterile barrier, which may allow microorganism introduction and infection risk.
Assembly screws in Philips Ingenia Ambition S MRI systems may loosen and protrude, potentially blocking the patient tabletop and delaying diagnosis. Philips is recalling 64 affected units worldwide.
Philips is recalling 68 MR 5300 MRI diagnostic systems worldwide because loose screws in the RF carrier assembly could block equipment movement and delay patient diagnosis.
Centinel Spine is recalling the Prodisc C SK cervical disc implant due to blue discoloration identified as foreign contamination on the inlay during assembly. The contamination was not fully evaluated in manufacturing validations.
Boston Scientific has recalled AGILE and WallFlex esophageal stent systems due to potential delivery catheter tip detachment. This defect could occur during stent deployment and affect proper stent placement.
GE Panda iRES infant warmers may have incomplete electrical safety testing that could cause leakage current to exceed safe limits. The company is recalling 137 units distributed in the US and internationally.
Boston Scientific is recalling WallFlex and Agile Esophageal Stent Systems due to potential delivery catheter tip detachment. The recall affects 231 units distributed worldwide.
M&P Delicacies frozen pirozhki pies contain undeclared wheat and milk allergens. Consumers with allergies to these ingredients should not consume the product.
Niitakaya USA Inc is recalling Miso Katsuo Ninniku pickled garlic because it contains undeclared fish allergen. Consumers with fish allergies should not consume this product.
Skagit River Bakery & Cafe is recalling marionberry scones distributed in Washington due to undeclared soy lecithin and soybean oil on labels. Consumers with soy allergies should not consume this product.
M&P Food Productions is recalling Potato & Onion Vareniki due to undeclared wheat. Consumers with wheat allergies or celiac disease should not consume this product.
M&P Food Productions is recalling Farmer Cheese Vareniki due to undeclared wheat and milk allergens. The frozen product was distributed across seven states from August 2023 to August 2024.
M&P Food Productions recalls frozen Pirozhki pies distributed across multiple states due to undeclared wheat and milk in the product. Consumers with wheat or milk allergies should not consume these products.
M&P Food Products Cheese Blintzes are recalled due to undeclared wheat in the product. Consumers with wheat allergies should not consume this frozen food.
Skagit River Bakery & Cafe is recalling approximately 1,200 units of bulk blueberry scones distributed in Washington because the labels fail to disclose soy lecithin and soybean oil. Consumers with soy allergies may be at risk.
M&P Food Products Cheese & Cherry Blintzes are recalled because they contain undeclared wheat. Consumers with wheat allergies should not consume this product.
Shiso Katsuo Ninniku pickled garlic products are being recalled due to an undeclared fish allergen. The recall affects 9,482 units distributed across seven states.
AbbVie is recalling Refresh P.M. lubricant eye ointment due to potential breaches in tube seals that may compromise product sterility. Approximately 2.4 million tubes were distributed nationwide and internationally.
Infla-650 Herbal Dietary Supplement is being recalled because it contains undeclared acetaminophen, diclofenac, and phenylbutazone. The product was marketed without FDA approval and poses a risk of drug interactions and adverse effects.
McKesson Medical-Surgical is recalling 27 bottles of Proparacaine Hydrochloride ophthalmic solution (lots 476261, 479751, 479741) due to temperature abuse that may have compromised sterility. Product was distributed to medical facilities in Maryland and Virginia.
Allergen is recalling specific lots of Refresh LACRI-LUBE eye ointment (763,426 tubes) due to potential breaches in the tube seal that may compromise sterility. Consumers should verify their product lot number against the recall list.
Glenmark Pharmaceuticals recalls Mupirocin Ointment nationwide due to subpotency, meaning some lots contain less active ingredient than specified. Affected customers should contact their pharmacy or prescriber.
Boston Scientific is recalling esophageal stent systems due to potential delivery catheter tip detachment during placement. Patients and providers with affected devices should contact the manufacturer for guidance.
Boston Scientific is recalling Wallflex and Agile esophageal stent systems due to potential delivery catheter tip detachment during stent placement procedures.
Cardinal Health is recalling Salem Sump Dual Lumen Stomach Tubes due to reports of anti-reflux valve breakage caused by improper use. Product labeling has been updated.
Arrow International recalls over 14,000 arterial kits due to reports of open packaging seals. The recall affects multiple models distributed nationwide.
Boston Scientific is recalling WallFlex and Agile esophageal stent systems (516 units) due to potential for delivery catheter tip detachment during stent placement procedures.
American Contract Systems recalls IR Procedure Pack (Lot 2405102, expiration 05/10/2024) because it cannot confirm sterilization requirements were met. An inoperable chart recorder caused humidity levels to be out-of-specification.
Boston Scientific has recalled 308 units of WallFlex and Agile esophageal stent systems due to the potential for delivery catheter tip detachment during stent placement. The affected devices are distributed worldwide.
Boston Scientific is recalling Wallflex Esophageal Stent Systems due to potential delivery catheter tip detachment that could affect proper stent deployment during medical procedures.
American Contract Systems is recalling Nasal Sinus Pack units due to manufacturing control failures that prevent confirmation of sterilization. Affected units were distributed to multiple states.
Philips is recalling 33 Ingenia 3.0T MRI scanners whose Integrated Radio Frequency Carrier assembly screws may come loose and block the horizontal tabletop, potentially causing diagnostic delays.
Centinel Spine is recalling the Prodisc C SK cervical disc replacement due to blue discoloration on the inlay observed during assembly. This discoloration is a foreign contaminant that was not fully evaluated in manufacturing validations.
Boston Scientific's Wallflex and Agile esophageal stent systems are recalled due to the potential for delivery catheter tip detachment. The recall affects 146 units distributed worldwide.
Philips recalls Evolution Upgrade 3.0T MRI devices due to loose screws that may block the tabletop and delay diagnosis. Devices with the affected serial numbers should be taken out of service.
Boston Scientific recalls WallFlex and Agile esophageal stent systems (305 units) due to potential delivery catheter tip detachment. Affected products were distributed worldwide.
American Contract Systems, Inc. is recalling the Bilateral Tubal Ligation Pack (Lot 2405102) due to inability to confirm proper sterilization following a chart recorder malfunction.
Siemens is recalling ACUSON Juniper ultrasound systems that may perform incorrect unit conversions when configured with non-default settings, potentially producing measurements 10 times smaller than actual values and risking patient misdiagnosis.
Karl Storz Hopkins Telescope 6 endoscopes are recalled because their Instructions for Use contain reprocessing procedures that the FDA has not reviewed or approved for safety and efficacy.
Karl Storz Hopkins Telescope 6 endoscopes are being recalled because the instructions for use contain reprocessing procedures not reviewed or approved by the FDA. Affected units should not be used until corrected instructions are provided.
Cook Biotech is recalling 130 units of Biodesign Fistula Plug C-FPS-0.7-2 surgical implants because the devices expire prior to the expiration date printed on the labeling. Devices were distributed worldwide including the US and 11 other countries.
504 paracentesis kits (Lot 2405102) are being recalled because the manufacturer cannot confirm that sterilization requirements were met during production.
American Contract Systems is recalling Cath Lab Pack CECL02P medical kits because an inoperable chart recorder caused humidity readings to be out-of-specification, preventing confirmation that sterilization requirements were met.
T.G. Eakin Limited is recalling blistered Cohesive seal ostomy barriers in Kentucky that are mislabeled with incorrect model numbers.
Boston Scientific recalls WallFlex and Agile esophageal stent systems due to potential delivery catheter tip detachment affecting 77 units distributed worldwide.
Cook Biotech, Inc. is recalling 102 units of Biodesign Fistula Plug C-FPS-0.7 because the products expire prior to the date printed on the labeling.
EnviroServe Chemicals Inc. is recalling EnviroClean Hand Sanitizer Gel due to manufacturing deviations. The voluntary recall affects 120 bottles distributed to one North Carolina distributor.
Stryker Spine recalled the electronic Instructions for Use revision 5 for the AVS Anchor-C Cervical Cage System because specific indications language for the US and Canada was inadvertently removed.
Cook Biotech is recalling Biodesign Inguinal Hernia Graft units because products expire before their labeled expiration date, potentially affecting surgical outcomes.
CooperSurgical, Inc. is recalling the Stainless Steel Sims Uterine Sound (Part Number 64-601) because some units were laser-marked with incorrect part numbers during manufacturing. No injuries have been reported.
SHEET SPF 30 Mineral sunscreen is being recalled for microbial contamination. The product was distributed nationwide.
CooperSurgical is recalling 468 units of Silver-Plated Copper Sims Uterine Sounds because they were laser-marked with the incorrect part number during manufacturing.
Karl Storz is recalling the Hopkins Telescope 6 endoscope because its Instructions for Use contain reprocessing procedures that have not been FDA-reviewed or approved. The recall affects 1,982 units distributed nationwide.
Cook Biotech is recalling 93 Biodesign Fistula Plugs because the products expire prior to the expiration date printed on the labeling.
Karl Storz Endoscope nephroscopes (REF: 27840KA) are being recalled because their instructions for use contain reprocessing methods that have not been reviewed or approved by the FDA for safety and efficacy.
GE Healthcare Centricity PACS versions V2-V7 may fail to store medical images when reaching maximum unique image identifiers, potentially resulting in incomplete imaging studies. No injuries have been reported.
Philips Ingenia 3.0T CX MRI machines may have loose screws in the RF carrier assembly that could protrude and interfere with the tabletop mechanism, potentially delaying patient scans.
Porsche is recalling 2021-2024 Taycan vehicles due to high-voltage battery short circuits that increase fire risk. Dealers will install diagnostic software and replace batteries as needed, advising owners to charge only to 80% capacity until repairs are completed.
Winnebago Industries recalls multiple motorhome models because turn signals may have insufficient lens area, making them difficult for other drivers to see and increasing crash risk. Dealers will replace the turn signals at no cost.
Navistar is recalling 2025 International CV vehicles because air bag modules may not have been activated during installation, increasing injury risk in crashes.
Porsche is recalling 2020-2023 Taycan vehicles due to a potential short circuit in the high-voltage battery that increases fire risk. Owners should limit charging to 80% until dealers replace the affected battery modules.
Porsche is recalling 2025 Taycan vehicles because the rearview camera image may not display immediately when shifting into reverse, increasing crash risk.
Chrysler is recalling specific MOPAR steering column control modules because the turn signal self-canceling feature may not function properly, increasing crash risk.
Navistar is recalling 2025 International HX and LT vehicles with Cummins X15 diesel engines due to fuel pump barrel fracture risk. The fracture can cause fuel leaks and engine stalls, increasing crash risk.
Chrysler is recalling 2023-2024 Ram 1500 vehicles because the turn signal self-canceling feature may not function properly, increasing crash risk.
Looking for a different month? Back to 2024.