CooperSurgical, Inc
53 recalls on record · Latest: Jul 30, 2025
CooperSurgical, Inc Recall Insight
CooperSurgical, Inc appears on 53 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.063% of the federal archive — a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Jul 30, 2025, which is the anchor point for assessing whether enforcement is currently active or historical.
On this page of 50 entries, severity tagging shows 1 critical, 42 moderate, and 7 lower-severity recalls. Affected-unit counts are disclosed on 50 of 50 entries — unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 2 distinct product categories, with issuing agencies dominated by FDA Devices (49), FDA Drug (1). The date window on this page runs from Nov 19, 2014 to Jul 30, 2025.
Manufacturer-level browsing is useful when monitoring a single firm for patterns — whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current — deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement — always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.
Endosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV. Endosee System Convenience Kit with IV Tube.
Brand Name: K-Systems Product Name: G85 Mini Incubator Model/Catalog Number: K22074 Software Version: N/A Product Description: An electrically-po…
Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23054 Software Version: N/A Product Description: An electrically-pow…
Brand Name: K-Systems Product Name: Multiple/unknown Model/Catalog Number: Multiple/unknown Software Version: N/A Product Description: An electri…
Brand Name: K-Systems Product Name: G73 Dry Bath Incubator Model/Catalog Number: K22065 Product Description: An electrically-powered device intend…
Stainless Steel Sims Uterine Sound, Part Number 64-601
Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Number: 84055060D
Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box of 3 Systems. Kit as labeled: Regard, Carter-Thomason CloseS…
Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect …
Cooper Surgical H/S ELLIPTOSPHERE CATH 5 FR Set-For administering contrast media during Hysterosalpingography or Hysterosonography procedures to dete…
CooperSurgical H/S CATHETER SET FR 5 with Integated Stylet Model: 61-4005S For administering contrast media during Hysterosalpingography or Hystero…
Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and transfer, Reference Number H5GT-060
BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for blastomere biopsy of cleavage stage embryos for Pre-implantation Genetic Diagnosis (PGD)
NEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540
Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark II Benchtop Incubator (AY200246)
Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark I Benchtop Incubator (AY102295). The Mark I model is no longer produ…
LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055
PARAGARD T380A (intrauterine copper contraceptive), 1 unit per carton together with an insertion tube and solid white rod in a Tyvek polyethylene pou…
Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075
LEEP PRECISION Integrated System, 220V CooperSurgical part numbers: LP-10-220
Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05W
LEEP PRECISION Generator 220V Cooper Surgical Part Number: LP-20-220
LEEP PRECISION Integrated System, 120V CooperSurgical part number: LP-10-120
CooperSurgical Wallach Loop Electrode 10mm x 10mm Square P/N: 909131. Disposable Universal Electrodes, LOOP electrodes, used for electro-excisional…
The Ultem Polymeric Resin Koh Cup is a non- sterile, reusable vaginal fornices delineator. It is made of medical grade plastics and not made with nat…
COOPERSURGICAL Os FinderTM Cervical Dilator, Taper: 2.0 mm to 4.0 mm OD Length: 21.5 cm Box of 50 Part Number: 1176
CooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea, P/N MX21
ADVANCED ENDOSEE System CANNULA, Cooper Surgical Product Code/Model Number: ESPX5 The Advanced Endosee Cannula (CooperSurgical Product Code: ESPX5…
Quantam 2000 Electrosurgical Generator, Part number 909075-05W.
Quantam 2000 Electrosurgical Generator, Part number 909075.
Embryology Heated Plate within the RI Witness, Model Numbers 6-70-807, 6-70-807-A, & 6-70-807-B - Product Usage: RI Witness uses Radio Frequency Iden…
LEEP Return Patient Pads (10/ box) Model # 6050Pl used in electrosurgical procedures.
TransWarmer Warming Infant Transport Mattress, Model no. 20421 Product Usage: The TransWarmer¿ Warming Infant Transport Mattress is gel-filled, …
LEEP Precision Integrated System 120V & LEEP Precision Generator, Model Nos. LP-10-120 & LP-20-120
Advincula Delineator with Ultem Plastic Soft Cup size 3.0 cm; Part No. AD750SC-KE30 The Advincula Delineator Uterine Manipulator is a single-use d…
Advincula Delineator with Ultem Plastic Soft Cup size 2.5 cm; Part No. AD750SC-KE25 The Advincula Delineator Uterine Manipulator is a single-use d…
LEEP Precision Integrated System 120V, Model LP-10-120 Product Usage: The LEEP PRECISION INTEGRATED SYSTEM l 20V combines three components - LEEP…
Colpo-Pneumo Occluder, Part CPO-6
Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) Product Usage: The Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG…
Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Freezing Medium . Product Number: ART -8017 SAGE In Vitro Fertilization, In…
Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Thawing Medium Product Number: ART-8018 Intended for use in freezing embry…
Milex Arcing Diaphragm Size 95; Model Number: MXWS95
CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Electrosurgical Excision Procedure P/N 6061
Milex Vaginal-Hymenal Silicone Dilators Set of 4 P/N MX20 Product Usage: The CooperSurgical Milex Vaginal-Hymenal Silicone Dilators are used f…
McKesson Medi-Pak Vaginal Speculum, 10/bag Reorder No. 11-8309 Used to expose interior of the vagina to facilitate visualization during gynecologic…
MediChoice WarmGel Infant Heel Warmer, Item # 1643069911 MediChoice Liquid Infant Heel Warmer, Item # 1643069912 Single Use and Disposable. Dis…
CooperSurgical Infant Heel Gel Warmers, P/N 20418 CooperSurgical The Infant Heal Warmer, P/N 2440 To provide gentle heat to increase blood flow a…
Fisher Brand Gel Infant Heel Gel Warmers, Cat. No.: 22-024647 Fisher Brand Liquid Infant Heel Warmer, Cat. No: 22-024646 To provide gentle heat …
Cooper Surgical CANNULA-CURETTE 12MM; Model Number: MX562 The CooperSurgical SUCTION CANNULA-CURETTE device is used to remove tissue from within t…
CooperSurgical MILEX PESSARY KITS- Hodge w/Support Folding Pessary- #1 Model: MXKPHS01 Product Usage: The CooperSurgical Milex silicon pessar…
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