RecallRadar

FDA Device recall Z-1944-2018

Symmetry Olsen bipolar forceps: (a1) Insulated Irrigating Bayonet Forceps 6.25" (15.9cm) Smooth 0.5mm Tips, REF 20-0311, QTY 5 (b1) Insulat…

On 2018-06-06 the FDA classified a Class II recall of Symmetry Olsen bipolar forceps: (a1) Insulated Irrigating Bayonet Forceps 6.25" (15.9cm) Smooth 0.5mm Tips, REF 20-0311, QTY 5 (b1) Insulat… by Olsen Medical, citing products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1944-2018
ClassificationClass II
Statusterminated
Initiated2018-05-11
Published2018-06-06
Last updated2026-09-13 11:54 UTC
CompanyOlsen Medical
Distributionn/a

Product

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

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

Identifiers

code_infoall codes

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1944-2018%22

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