Pemco Rultract Retractor Ratchet Cover Plate Recalled for Corrosion
Pemco Inc. is recalling 87 Rultract Retractor Ratchet Cover Plates because a returned unit showed signs of corrosion. The devices are used in surgery to lift incision sites.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a structural defect (corrosion) that poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
Pemco Inc. is recalling 87 units of the Rultract Retractor Ratchet Cover Plate. These surgical retractors are used to lift the incision site during procedures. The recall was initiated after the firm became aware that a ratchet cover plate on a device returned for repair showed signs of corrosion.
The affected units were distributed worldwide, including in the United States and internationally to the Czech Republic, Italy, Japan, Korea, and Singapore. Specific model and serial numbers are listed in the recall documentation. The source text does not report any illnesses or injuries associated with this defect.
Healthcare facilities and consumers should stop using the affected Rultract Retractor Ratchet Cover Plates immediately. Pemco Inc. is the recalling firm and is responsible for managing the recall process.
The recalled product
- Product
- Rultract Retractor Ratchet Cover Plate Distributed by Pemco, Inc., Cleveland, OH 44131 Surgical retractor used to lift the incision site
- Manufacturer
- Pemco Inc
- Affected units
- 87
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- M/N 4100-IMR-6: S/N's: 4829-4839
- 4845-4851
- 4857-4871
- 4874-4884
- 4894-4908 & 4916-4923
- M/N 4100-IMR-41: S/N's: 4840-4844
- 4852-4856
- 4888-4893
- 4913-4915 & 4926-4927.
Distribution
Related recalls
Same hazard · corrosion
See all →- HighToyota 2024 Tacoma rear shock absorber suspension recall issued
NHTSA · 2026-08-06
- High
- HighArvis Hip and Knee 2.0 trackers may show wear and corrosion
FDA (Devices) · 2026-06-10
- HighPhaseOne antimicrobial solution sprayer springs may corrode into the product
FDA (Devices) · 2026-06-10
- HighArvis Hip and Knee 3.0 trackers may show wear and corrosion
FDA (Devices) · 2026-06-10
Similar recalls
- HighApplied Medical Resources Recalls Clip Applier Kits Due to Tissue Damage Risk
FDA (Devices) · 2020-06-03
- HighGE Healthcare Recalls NM/CT 870 CZT Systems Due to Loose Rotor Screws
FDA (Devices) · 2021-01-20
- SevereReliance Medical Products Recalls Refractor Suspension Arms Due to Missing Parts
FDA (Devices) · 2018-04-18
- HighUS Endoscopy Raptor Grasping Device Recalled for Potential Jaw Failure
FDA (Devices) · 2012-10-10
- HighApplied Medical Recalls TLC Self Retaining Retractor Systems Due to Sterilization Breach
FDA (Devices) · 2016-05-11
- HighAAP Implantate Soft Tissue Retractor Recalled for Manufacturing Defect
FDA (Devices) · 2020-04-15