Coopersurgical recalls

Coopersurgical appears in 86 official U.S. recall notices indexed by RecallRadar.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

• TransWarmer Warming Infant Transport Mattress, Model no. 20421 Product Usage: The TransWarmer¿ Warming Infant Transport Mattress is gel-fil…
  FDA Device · Class II · 2019-09-04 · Coopersurgical
  Reason: The firm updated the IFU in April 2019 to clarify that use of the TRANSWARMER Mattress with other heat producing devices, such as an incubator, is prohibited and could lead to serious health consequences, such as skin b…
• LEEP Precision Integrated System 120V & LEEP Precision Generator, Model Nos
  FDA Device · Class II · 2019-07-31 · Coopersurgical
  Reason: The products' cut, coagulate, or blend function may not operate with the use of the Foot Pedal.
• Advincula Delineator with Ultem Plastic Soft Cup size 2.5 cm
  FDA Device · Class II · 2019-07-24 · Coopersurgical
  Reason: The soft, flexible cup of the Advincula Delineator may be unvalidated and could potentiall crack when subjected to excessive compressions during use, leading to serious health consequences, such as lacerations.
• Advincula Delineator with Ultem Plastic Soft Cup size 3.0 cm
  FDA Device · Class II · 2019-07-24 · Coopersurgical
  Reason: The soft, flexible cup of the Advincula Delineator may be unvalidated and could potentiall crack when subjected to excessive compressions during use, leading to serious health consequences, such as lacerations.
• LEEP Precision Integrated System 120V, Model LP-10-120 Product Usage: The LEEP PRECISION INTEGRATED SYSTEM l 20V combines three components…
  FDA Device · Class II · 2019-06-26 · Coopersurgical
  Reason: 2.5A slow blow fuses may have been installed in the LEEP RPECISION Generator rather than the appropriate 3.15A slow blow fuses.
• ICSI MICROPIPETTE CooperSurgical part number: MICC001-30-B1.0
  FDA Device · Class II · 2019-05-29 · Coopersurgical
  Reason: ICSI CUSTOM MICROPIPETTES the thirty-degree bend is absent
• Colpo-Pneumo Occluder, Part CPO-6
  FDA Device · Class II · 2018-10-17 · Coopersurgical
  Reason: The seal of the sterile pouch may be compromised, thereby increasing the risk of infection.
• Retractor System Elastic Stays (Part 3314-lG
  FDA Device · Class II · 2018-10-03 · Coopersurgical
  Reason: There is a possibility that the seal of the sterile pouch may be compromised, thereby increasing the risk of infection.
• Fischer Cone Biopsy Excisor, Medium (5/Box)
  FDA Device · Class II · 2018-05-23 · Coopersurgical
  Reason: Products have been packaged with an incorrect product size.
• 5 mm Apple-Hunt Secondary Cannula/Pyramidal Tip Trocar - extended length (5 count)
  FDA Device · Class II · 2018-05-09 · Coopersurgical
  Reason: Products have been packaged with the wrong Trocar length type.
• Cooper Surgical 2 MHZ Waterproof OB Probe Product The CooperSurgical 2 MHz Waterproof OB probe is for obstetrical use in the labor and depa…
  FDA Device · Class II · 2018-03-28 · Coopersurgical
  Reason: The 2MHZ prove was incorrectlhttp://cts.fda.gov/division-tracking/images/trash.pngy labeled as a 3MHZ probe
• CooperSurgical lnflatoball Latex Rubber Pessary sold as an individual unit and also part of the lnflatoball Pessary Kit
  FDA Device · Class II · 2017-05-17 · Coopersurgical
  Reason: The current secondary packaging, a box, incorrectly states that the product is latex free. The product is made with 100% latex. The label on the package that contains the product and the Instructions for Use (IFU) corre…
• Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Thawing Medium Product Number: ART-8018 Intended for use in freezin…
  FDA Device · Class III · 2016-09-28 · Coopersurgical
  Reason: Products contain international package insert and not the correct USA package insert
• Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Freezing Medium . Product Number: ART -8017 SAGE In Vitro Fertiliza…
  FDA Device · Class III · 2016-09-28 · Coopersurgical
  Reason: Products contain international package insert and not the correct USA package insert
• Milex Arcing Diaphragm Size 95
  FDA Device · Class II · 2016-03-16 · Coopersurgical
  Reason: The products have been identified to contain an incorrect size Diaphragm.
• MILEX PESSARY KIT
  FDA Device · Class III · 2015-11-18 · Coopersurgical
  Reason: The products have been identified to have incorrect size prints on the MILEX PESSARY KIT packaging. While the Pessary pouch is marked with correct size, an incorrect label on the packaging does not meet the required rel…
• CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Electrosurgical Excision Procedure P/N 6061
  FDA Device · Class III · 2015-10-14 · Coopersurgical
  Reason: Kit Label incorrect :Labeled with Lidocaine HCI drug cartridges Lidocaine HCl (2%) but contains vials Lidocaine HCl (1%)
• Infant Heel Warmer and Infant Gel Warmer, sold under the brand names CooperSurgical and Fisher brand as follows : CooperSurgical PN 20418 W…
  FDA Device · Class II · 2015-07-29 · Coopersurgical
  Reason: Product marketed without a 510(k)
• Milex Vaginal-Hymenal Silicone Dilators Set of 4 P/N MX20 Product Usage: The CooperSurgical Milex Vaginal-Hymenal Silicone Dilators are use…
  FDA Device · Class II · 2015-07-29 · Coopersurgical
  Reason: Incorrect expiration date on outer carton kit label
• McKesson Medi-Pak Vaginal Speculum, 10/bag Reorder No. 11-8309 Used to expose interior of the vagina to facilitate visualization during gyn…
  FDA Device · Class II · 2015-07-01 · Coopersurgical
  Reason: Small sized specula were incorrectly packaged in printed bags for the medium sized speculum
• MILEX OMNIFLEX DIAPHRAGM SIZE 80 Model: MXWF80
  FDA Device · Class II · 2015-06-24 · Coopersurgical
  Reason: A diaphragm size 80 labeled box was incorrectly packaged with a size 85.
• Ally Uterine Positioning System (Ally UPS) used in the mounting and positioning and holding of uterine manipulators during gynecological la…
  FDA Device · Class II · 2015-06-17 · Coopersurgical
  Reason: Design of device may expose user to injury to fingers or body parts
• Carter-Thomason II Port Closure System
  FDA Device · Class II · 2015-05-27 · Coopersurgical
  Reason: The pad printing around the suture entry holes on the 15mm Suture Guide included in the kit may not have been appropriately manufactured resulting in the pad printing flaking off around the entry holes.
• WALLACH LL 100 cryosurgical units: LL100 Cryosurgical - Part Number 900001
  FDA Device · Class II · 2015-04-22 · Coopersurgical
  Reason: Internal gas line may malfunction causing the line to burst under pressure.
• CooperSurgical TransWarmer Infant Transport Mattress with WarmGel P/N 20421 Private label: NovaPlus TransWarmer Infant Heat Therapy Mattres…
  FDA Device · Class II · 2015-04-15 · Coopersurgical
  Reason: Trans Warmer Infant and Transport Mattress not labeled with exp.date may not meet specification
• NovaPlus Brand Warm Gel Infant Heel Gel Warmer, Item # V6391 NovaPlus Brand Liquid Heal Warmer
  FDA Device · Class II · 2015-03-25 · Coopersurgical
  Reason: Products without expiration date have the remote potential for minor burn
• Fisher Brand Gel Infant Heel Gel Warmers, Cat
  FDA Device · Class II · 2015-03-25 · Coopersurgical
  Reason: Products without expiration date have the remote potential for minor burn
• MediChoice WarmGel Infant Heel Warmer, Item # 1643069911 MediChoice Liquid Infant Heel Warmer, Item # 1643069912 Single Use and Disposable
  FDA Device · Class II · 2015-03-25 · Coopersurgical
  Reason: Products without expiration date have the remote potential for minor burn
• CooperSurgical Infant Heel Gel Warmers, P/N 20418 CooperSurgical The Infant Heal Warmer, P/N 2440 To provide gentle heat to increase blood…
  FDA Device · Class II · 2015-03-25 · Coopersurgical
  Reason: Products without expiration date have the remote potential for minor burn
• CooperSurgical PESSARY KIT-CUBE#2, 1-3/8 in , 35 mm Part Number: MXKPEC02
  FDA Device · Class II · 2015-03-11 · Coopersurgical
  Reason: Incorrect size printed on the Milex Pessary Kit packaging label
• Cooper Surgical CANNULA-CURETTE 12MM
  FDA Device · Class III · 2014-12-10 · Coopersurgical
  Reason: The product has been identified to contain an incorrect curette type.
• CooperSurgical LEEP RADIUS LOOP ELECTRODE (W 2.0 cm x D 1.0 cm D, 12 cm shaft ). Box of 5 Model Number(s): R2010 Intended Use: Diagnosis an…
  FDA Device · Class II · 2014-12-03 · Coopersurgical
  Reason: Outer box is mislabeled as P/N R2010- Large Radius Loop Electrode instead of P/N R1010- Medium Radius Loop Electrode
• CooperSurgical MILEX PESSARY KITS-Ring w/Support Folding Pessary- #1 Model: MXKPRS01 Product Usage: The CooperSurgical Milex silicon pessar…
  FDA Device · Class III · 2014-11-19 · Coopersurgical
  Reason: Incorrect expiration date printed on the MILEX PESSARY KIT packaging
• CooperSurgical MILEX PESSARY KITS- Hodge w/Support Folding Pessary- #1 Model: MXKPHS01 Product Usage: The CooperSurgical Milex silicon pess…
  FDA Device · Class III · 2014-11-19 · Coopersurgical
  Reason: Incorrect expiration date printed on the MILEX PESSARY KIT packaging
• CooperSurgical H/S CATHETER (PART # 61-5007) Intended for Hysterosonography/ Hysterosalpingography
  FDA Device · Class II · 2014-09-17 · Coopersurgical
  Reason: Unsealed pouches.
• Cooper Surgical TAMPA CATHETER 5 French 33 cm
  FDA Device · Class II · 2014-06-18 · Coopersurgical
  Reason: Sterility of the device may be compromised due to unsealed pouch