CLASS II Device recall · Reported 3 Jun 2020 · FDA Enforcement Report
Clip Applier Kit recalled by Applied Medical Resources
Applied Medical Resources is recalling Clip Applier Kit, distributed in 43 states. The recall was initiated on 17 Mar 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2161-2020
- FDA event ID
- 85436
- Recalling firm
- Applied Medical Resources, Rancho Santa Margarita, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Mar 2020
- FDA classified
- 28 May 2020
- Reported
- 3 Jun 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Other Medical Devices
Timeline
| 17 Mar 2020 | Recall initiated by company | |
| 28 May 2020 | Classified by FDA | +72 days |
| 3 Jun 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to tissue damage.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
Clip Applier Kit, REF: K2887, UDI: (01)30607915139132(17)220822(30)1(10)
Where it was distributed
US: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY OUS: Argentina, Australia, Austria, Belgium, Canada, Chile, Costa Rica, Denmark, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Latvia, Liechtenstein, Luxembourg, Netherlands, New Zealand, Peru, Portugal, Serbia, Singapore, South Africa, Spain, Thailand, United Kingdom
AlabamaArkansasArizonaCaliforniaColoradoConnecticutFloridaGeorgiaHawaiiIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouriMississippi
Questions about this recall
Is Clip Applier Kit recalled?
Yes. Applied Medical Resources recalled Clip Applier Kit on 17 Mar 2020. The recall is Class II and its status is Terminated. Recall number Z-2161-2020.
Why was it recalled?
There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to tissue damage.
Which lots are affected?
Batch: 1380797, 1382197
Where was it sold?
US: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY OUS: Argentina, Australia, Austria, Belgium, Canada, Chile, Costa Rica, Denmark, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Latvia, Liechtenstein, Luxembourg, Netherlands, New Zealand, Peru, Portugal, Serbia, Singapore, South Africa, Spain, Thailand, United Kingdom
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Applied Medical Resources
All 30| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Kii Low Profile, Bladed Dual Pack , Qty recalled | Applied Medical Resources | Packaging Defects | CA, ME, MI |
| Device | CLASS II | Epix Universal Clip Applier recalled by Applied Medical Resources | Applied Medical Resources | E. coli | Nationwide |
| Device | CLASS II | Epix Universal Clip Applier recalled by Applied Medical Resources | Applied Medical Resources | Sterility | Nationwide |
| Device | CLASS II | Epix latis Grasper recalled by Applied Medical Resources | Applied Medical Resources | Lead & Heavy Metals | 43 states |
| Device | CLASS II | Epix latis Grasper recalled by Applied Medical Resources | Applied Medical Resources | Lead & Heavy Metals | 43 states |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |