O&M HALYARD, INC. recalls Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Description: Laparotomy Pack…
Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging.
Read the official notice →- Date
- 2025-01-29
- Country
- United States
- Brand
- O&M Halyard
- Product
- Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Description: Laparotomy Pack…
- Classification
- Class II
- Units
- US Nationwide distribution in the states of CO, FL, GA, HI, IA, IL, IN, KS,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More O&M Halyard recalls
- 2026-06-03
USO&M HALYARD INC recalls Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS), 48772 (Sm.), 48773 (Md.), 48774 (Lg.), 48775 (Xl)
Nitrile Exam Glove failed to meet specifications chemical permeation performance.
FDA · DeviceO&M HALYARD INCUS Nationwide distribution in the states of GA, CA, NJ, MA, NY, NC.Official notice →- 2025-09-10
- US
O&M HALYARD INC recalls Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029
Surgical drape packs may have open seals, which may compromise the sterility of the product.
FDA · DeviceO&M HALYARD INCWorldwide - US Nationwide distribution in the states of GA, AL, PA and the…Official notice → - 2025-01-01
- US
O&M HALYARD, INC. recalls O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47117
Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Face masks sold in the United States are not required to meet this standard. However, if the standard is printed on the…
- 2024-04-10
- US
O&M HALYARD, INC. recalls HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100)
Product was mislabeled as a Surgical Cap at its dispenser level.
FDA · DeviceO&M HALYARD, INC.Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, HI,…Official notice → - 2023-09-27
- US
O&M HALYARD, INC. recalls FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size small, Product Code 46827
One respirator sample failed a filtration efficiency test. This respirator may not provide adequate protection to the user.
FDA · DeviceO&M HALYARD, INC.US Distribution to States of: FL, GA, IA, IL, MO, MS, NE, OK, TN, TX, WI and…Official notice → - 2021-12-08
- US
O&M HALYARD INC recalls HALYARD STERLING ZERO NITRILE POWDER-FREE EXAM GLOVES, Sizes XS, S, M, L, and XL
All lots of the glove may discolor and lose elasticity upon aging, resulting in the inability of the user to don the gloves without tearing.
FDA · DeviceO&M HALYARD INCWorldwide distribution - US Nationwide and the countries of EU/Canada.Official notice →
Other drugs & medical recalls in the United States
- 2025-01-29
- US
St. Jude Medical recalls CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Hosptial Electronics System (PES) REF CM3000 Merlin.net Patient Care…
As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure readings.
FDA · DeviceSt. Jude MedicalWorldwide - U.S. Nationwide distribution including in the states of AL, AR,…Official notice → - US
St. Jude Medical recalls Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN6000) (Which interfaces with CardioMEMS" Hospital System…
Due to a data migration from on-premises server to the cloud environment, some customers reported that they were not able to transmit readings.
FDA · DeviceSt. Jude MedicalU.S.: CA, CT, GA, IL, MI, MN, NC, NJ, NY, OR, PA, TX, and WA. O.U.S.: N/AOfficial notice → - US
Medtronic Perfusion Systems recalls DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)
Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
- US
Stryker Corporation recalls stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to cut bone and bone cement during neurosurgery
There is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-430 but package contains a 5820-107-530 device or vice versa).
FDA · DeviceStryker CorporationWorldwide distribution - US Nationwide and the countries of UK, Netherlands,…Official notice → - US
Integra LifeSciences Corp. recalls CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810 Implantable device that provides constant…
Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
FDA · DeviceIntegra LifeSciences Corp.US Nationwide distribution in the states of FL, NC, MA, MN, OH, DC, VA, CA,…Official notice → - US
CareFusion 303, Inc. recalls BD Pyxis Med ES Auxiliary (AUX), REF 343
Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified: Situation 1: Door Latch Failure,…