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CooperSurgical Recalls
84 recalls on record · June 18, 2014 to July 30, 2025 · Drugs, Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
Also filed under
The recall feeds record what looks like the same company under more than one name:
September 28, 2016Medical DevicesFDA
CooperSurgical, Inc. recalls Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Thawing Medium Product Number: ART-8018 Inten
Hazard: Products contain international package insert and not the correct USA package insert
September 28, 2016Medical DevicesFDA
CooperSurgical, Inc. recalls Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Freezing Medium . Product Number: ART -8017 SA
Hazard: Products contain international package insert and not the correct USA package insert
March 16, 2016Medical DevicesFDA
CooperSurgical, Inc. recalls Milex Arcing Diaphragm Size 95; Model Number: MXWS95
Hazard: The products have been identified to contain an incorrect size Diaphragm.
November 18, 2015Medical DevicesFDA
CooperSurgical, Inc. recalls MILEX PESSARY KIT; Model Numbers: MXPES00; MXKPES00; MXKPREG03; MXKPGSK07 Product Usage: The Coopersurgical MILEX SI
Hazard: 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 release specification.
October 14, 2015Medical DevicesFDA
CooperSurgical, Inc. recalls CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Electrosurgical Excision Procedure P/N 6061
Hazard: Kit Label incorrect :Labeled with Lidocaine HCI drug cartridges Lidocaine HCl (2%) but contains vials Lidocaine HCl (1%)
July 29, 2015Medical DevicesFDA
CooperSurgical, Inc. recalls Infant Heel Warmer and Infant Gel Warmer, sold under the brand names CooperSurgical and Fisher brand as follows : Coope
Hazard: Product marketed without a 510(k)
July 29, 2015Medical DevicesFDA
CooperSurgical, Inc. recalls Milex Vaginal-Hymenal Silicone Dilators Set of 4 P/N MX20 Product Usage: The CooperSurgical Milex Vaginal-Hymenal
Hazard: Incorrect expiration date on outer carton kit label
July 1, 2015Medical DevicesFDA
CooperSurgical, Inc. recalls McKesson Medi-Pak Vaginal Speculum, 10/bag Reorder No. 11-8309 Used to expose interior of the vagina to facilitate vis
Hazard: Small sized specula were incorrectly packaged in printed bags for the medium sized speculum
June 24, 2015Medical DevicesFDA
CooperSurgical, Inc. recalls MILEX OMNIFLEX DIAPHRAGM SIZE 80 Model: MXWF80
Hazard: A diaphragm size 80 labeled box was incorrectly packaged with a size 85.
June 17, 2015Medical DevicesFDA
CooperSurgical, Inc. recalls Ally Uterine Positioning System (Ally UPS) used in the mounting and positioning and holding of uterine manipulators du
Hazard: Design of device may expose user to injury to fingers or body parts
May 27, 2015Medical DevicesFDA
CooperSurgical, Inc. recalls Carter-Thomason II Port Closure System; Model Number(s) CTI-1015P, for use in endoscopic and laparoscopic surgery.
Hazard: 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.
April 22, 2015Medical DevicesFDA
CooperSurgical, Inc. recalls WALLACH LL 100 cryosurgical units: LL100 Cryosurgical - Part Number 900001; LL110 with Pinned Yoke - Part Number 900019-
Hazard: Internal gas line may malfunction causing the line to burst under pressure.
April 15, 2015Medical DevicesFDA
CooperSurgical, Inc. recalls CooperSurgical TransWarmer Infant Transport Mattress with WarmGel P/N 20421 Private label: NovaPlus TransWarmer Infa
Hazard: Trans Warmer Infant and Transport Mattress not labeled with exp.date may not meet specification
March 25, 2015Medical DevicesFDA
CooperSurgical, Inc. recalls NovaPlus Brand Warm Gel Infant Heel Gel Warmer, Item # V6391 NovaPlus Brand Liquid Heal Warmer. Item #V6393 Single Us
Hazard: Products without expiration date have the remote potential for minor burn
March 25, 2015Medical DevicesFDA
CooperSurgical, Inc. recalls MediChoice WarmGel Infant Heel Warmer, Item # 1643069911 MediChoice Liquid Infant Heel Warmer, Item # 1643069912 Sing
Hazard: Products without expiration date have the remote potential for minor burn
March 25, 2015Medical DevicesFDA
CooperSurgical, Inc. recalls Fisher Brand Gel Infant Heel Gel Warmers, Cat. No.: 22-024647 Fisher Brand Liquid Infant Heel Warmer, Cat. No: 22-02
Hazard: Products without expiration date have the remote potential for minor burn
March 25, 2015Medical DevicesFDA
CooperSurgical, Inc. recalls CooperSurgical Infant Heel Gel Warmers, P/N 20418 CooperSurgical The Infant Heal Warmer, P/N 2440 To provide gentle
Hazard: Products without expiration date have the remote potential for minor burn
March 11, 2015Medical DevicesFDA
CooperSurgical, Inc. recalls CooperSurgical PESSARY KIT-CUBE#2, 1-3/8 in , 35 mm Part Number: MXKPEC02
Hazard: Incorrect size printed on the Milex Pessary Kit packaging label
December 10, 2014Medical DevicesFDA
CooperSurgical, Inc. recalls Cooper Surgical CANNULA-CURETTE 12MM; Model Number: MX562 The CooperSurgical SUCTION CANNULA-CURETTE device is used t
Hazard: The product has been identified to contain an incorrect curette type.
December 3, 2014Medical DevicesFDA
CooperSurgical, Inc. recalls 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 Inten
Hazard: Outer box is mislabeled as P/N R2010- Large Radius Loop Electrode instead of P/N R1010- Medium Radius Loop Electrode
November 19, 2014Medical DevicesFDA
CooperSurgical, Inc. recalls CooperSurgical MILEX PESSARY KITS- Hodge w/Support Folding Pessary- #1 Model: MXKPHS01 Product Usage: The Cooper
Hazard: Incorrect expiration date printed on the MILEX PESSARY KIT packaging
November 19, 2014Medical DevicesFDA
CooperSurgical, Inc. recalls CooperSurgical MILEX PESSARY KITS-Ring w/Support Folding Pessary- #1 Model: MXKPRS01 Product Usage: The CooperSur
Hazard: Incorrect expiration date printed on the MILEX PESSARY KIT packaging
September 17, 2014Medical DevicesFDA
CooperSurgical, Inc. recalls CooperSurgical H/S CATHETER (PART # 61-5007) Intended for Hysterosonography/ Hysterosalpingography.
Hazard: Unsealed pouches.
June 18, 2014Medical DevicesFDA
CooperSurgical, Inc. recalls Cooper Surgical TAMPA CATHETER 5 French 33 cm. Intended for Hysterosonography. Model Number: 61-2005
Hazard: Sterility of the device may be compromised due to unsealed pouch