OBP Medical Corporation recalls OBP Medical
Reason for recall
There is a potential for vaginal speculums to contain a burr on the proximal plastic blade, which may introduce a sharp edge in the contact regions for both the patient and the healthcare provider.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small REF:C020130-16 affected lots24J1202Z25D2302Z25A0202Z25E1502Z25B2802Z25L0802Z
What the firm is doing
On July 14, 2026, OBP Medical a subsidiary of Cooper Surgical issued a Urgent Medical Device Recall Notification to affected consignees via UPS. OBP Medical asked consignees to take the following actions: 1. Physicians/Facilities: Please remove all product of the subject lots from your inventory and note the number of units to be returned on the attached Recall Response Form. 2. Distributors: Please remove all product of the subject lots from your inventory and note the number of units to be returned on the attached Distributor Only Acknowledgement Form. Per the instructions, please communicate this recall notification to all customers that you distributed these devices to. 3. If you are aware of malfunctions or adverse events involving the subject devices which you have not previously reported please report via: Cooper Surgical Customer Complaint Form or FDA's MedWatch Voluntary Form
DistributionShow detailsHide
Worldwide - US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV and the countries of HKG, CAN, NOR, UAE.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2933-2026
- FDA 510(k) clearance · K091937The device's official FDA premarket clearance record
- FDA device classification · HIBOfficial FDA classification for this device type
- CFR regulation · 21 CFR 884.4530The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find OBP Medical CorporationSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
More Class II recalls
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) BASIC PACK
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
- Eye Tray
- Nonconforming Material/Component
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) KIT
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
- Orthopedic Tray
- Nonconforming Material/Component
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 2
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
- Neurological Tray
- Nonconforming Material/Component
