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Symmetry Olsen bipolar forceps: (a1) Insulated Irrigating Bayonet Forceps 6.25" (15.9cm) Smooth...

FDA Device Recall #Z-1944-2018 — Class II — May 11, 2018

Recall Summary

Recall Number Z-1944-2018
Classification Class II — Moderate risk
Date Initiated May 11, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Olsen Medical
Location Louisville, KY
Product Type Devices
Quantity 611,817 devices

Product Description

Symmetry Olsen bipolar forceps: (a1) Insulated Irrigating Bayonet Forceps 6.25" (15.9cm) Smooth 0.5mm Tips, REF 20-0311, QTY 5 (b1) Insulated Irrigating Bayonet Forceps 6.25" (15.9cm) Smooth 0.5mm Tips, REF 20-0311R, QTY 5 (c1) Insulated Irrigating Bayonet Forceps 6.25" (15.9cm) Smooth 1.0mm Tips, REF 20-0321, QTY 5 (d1) Insulated Irrigating Bayonet Forceps 6.25" (15.9cm) Smooth 1.5mm Tips, REF 20-0331, QTY 5 (e1) Insulated Irrigating Bayonet Forceps 6.25" (15.9cm) Smooth, 1.5mm Tips, REF 20-0331R, QTY 5 (f1) Insulated Irrigating Bayonet Forceps 7-1/8" (18.1cm) Smooth Micro Tips, REF 20-0351, QTY 5 (g1) Insulated Irrigating Bayonet Forceps 7-1/8" (18.1cm) Smooth 0.5mm Tips, REF 20-0361, QTY 5 (h1) Insulated Irrigating Bayonet Forceps 7-1/8" (181.0mm) 0.5mm Tips, REF 20-0361G, QTY 5 (i1) Insulated Irrigating Bayonet Forceps 7-1/8" (18.1cm) Smooth 0.5mm Tips, REF 20-0361R, QTY 5 (j1) Insulated Irrigating Bayonet Forceps 7-1/8" (18.1cm) Smooth 1.0mm Tips, REF 20-0371, QTY 5 (k1) Insulated Irrigating Bayonet Forceps 7-1/8" (18.1cm) Smooth 1.0mm Tips, REF 20-0371R, QTY 5 (l1) Insulated Irrigating Bayonet Forceps 7-1/8" (18.1cm) Smooth 1.5mm Tips, REF 20-0381, QTY 5 (m1)Insulated Irrigating Bayonet Forceps 7-1/8" (181.0mm) 1.5mm Tips, REF 20-0381G, QTY 5 (n1) Insulated Irrigating Bayonet Forceps 7-1/8" (18.1cm) Smooth 1.5mm Tips, REF 20-0381R, QTY 5 (o1) Insulated Irrigating Bayonet Forceps 8.25" (21.0cm) Smooth 0.5mm Tips, REF 20-0411, QTY 5 (p1) Insulated Irrigating Bayonet Forceps 8.25" (21.0cm) Smooth 0.5mm Tips, REF 20-0411R, QTY 5 (q1) Insulated Irrigating Bayonet Forceps 8.25" (21.0cm) Smooth 1.0mm Tips, REF 20-0421, QTY 5 (r1) Insulated Irrigating Bayonet Forceps 8.25" (21.0cm) Smooth 1.0mm Tips, REF 20-0421R, QTY 5 (s1) Insulated Irrigating Bayonet Forceps 8.25" (21.0cm) Smooth 1.5mm Tips, REF 20-0431, QTY 5 (t1) Insulated Irrigating Bayonet Forceps 8.25" (309.6mm) 1.5mm Tips, REF 20-0431G, QTY 5 (u1) Insulated Irrigating Bayonet Forceps 8.25" (21.0cm) Smooth 1.5mm Tips, REF 20-0431R, QTY 5 (v1) Insulated Irrigating Bayonet Forceps 10.5" (26.7cm) Smooth 1.0mm Tips, REF 20-0481, QTY 5 (w1) Insulated Irrigating Bayonet Forceps 10.5" (26.7cm) Smooth 1.0mm Tips, REF 20-0481R, QTY 5 (x1) Insulated Irrigating Bayonet Forceps 10.5" (26.7cm) Smooth 1.5mm Tips, REF 20-0491, QTY 5 (y1) Insulated Irrigating Bayonet Forceps 10.5" (26.7cm) Smooth 1.5mm Tips, REF 20-0491R (z1) Precision Non-Stick Insulated Irrigating Forceps 7" (17.8cm) 0.5mm Tips, REF 20-0571IMT, QTY 5 (a2) Precision Non-Stick Insulated Irrigating Forceps 7" (17.8cm) 1.0mm Tips, REF 20-0572IMT, QTY 5 (b2) Precision Non-Stick Insulated Irrigating Forceps 7" (17.8cm) 1.5mm Tips, REF 20-0573IMT, QTY 5 (c2) Precision Non-Stick Insulated Irrigating Forceps 8" (20.3cm) 0.5mm Tips, REF 20-0581IMT, QTY 5 (d2) Precision Non-Stick Insulated Irrigating Forceps 8" (20.3cm) 1.0mm Tips, REF 20-0582IMT, QTY 5 (e2) Precision Non-Stick Insulated Irrigating Forceps 8" (20.3cm) 1.5mm Tips, REF 20-0583IMT, QTY 5 (f2) Precision Non-Stick Insulated Irrigating Forceps 9" (22.9cm) 0.5mm Tips, REF 20-0591IMT, QTY 5 (g2) Precision Non-Stick Insulated Irrigating Forceps 9" (22.9cm) 1.0mm Tips, REF 20-0592IMT, QTY 5 (h2) Precision Non-Stick Insulated Irrigating Forceps 9" (22.9cm) 1.5mm Tips, REF 20-0593IMT (i2) Insulated Coaptation Forceps 4.5" (11.4cm) Smooth Micro Tips, Angled, REF 20-1010KI, QTY 10 (j2) Iris Forceps 4.5" (11.4cm) Serrated 1.0mm Tips, REF 20-1030K, QTY 10 (k2) Iris Forceps 4.5" (11.4cm) Serrated 1.0mm Tips, Angled 45o, REF 20-1040K, QTY 10 (l2) Insulated Iris Forceps 4.5" (11.4cm) Serrated 1.0mm Tips, Angled 45o, REF 20-1040KI, QTY 10 (m2) Jewelers Forceps 4.5" (11.4cm) Smooth Micro Tips, REF 20-1060K, QTY 10 (n2) Jewelers Forceps 4.5" (11.4cm) Smooth Micro Tips, REF 20-1060K-28, QTY 10 (o2) Insulated Jewelers Forceps 4.5" (11.4cm) Smooth Micro Tips, REF 20-1060KI, QTY 10 (p2) Insulated Jewelers Forceps 4.5" (11.4cm) Smooth Micro Ti

Reason for Recall

Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised.

Distribution Pattern

Worldwide Distribution

Lot / Code Information

all codes

Other Recalls from Olsen Medical

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Z-1942-2018 Class II Symmetry Olsen bipolar cord: (a) Bipolar Cord,... May 11, 2018
Z-1941-2018 Class II Symmetry Olsen Monopolar Pencil: (a) Button Sw... May 11, 2018
Z-1945-2018 Class II Symmetry Olsen monopolar forceps: (a) Insulat... May 11, 2018
Z-1943-2018 Class II Symmetry Olsen monopolar cord: (a) Monopolar ... May 11, 2018

Frequently Asked Questions

Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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