Synergetics Inc

Complete recall history across all FDA and CPSC categories — 37 total recalls

Synergetics Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (37)

FDA medical device enforcement actions by Synergetics Inc

Date Product Reason Class
Jun 12, 2024 BAUSCH+LOMB, I-PACK Injection Kit Custom, REF 18069, for the administration ... Sterilization certificates could not be validated by the supplier Class I
Jun 12, 2024 BAUSCH+LOMB, I-PACK Injection Kit with Wire Speculum, REF 18069W, for the ad... Sterilization certificates could not be validated by the supplier Class I
Jun 12, 2024 BAUSCH+LOMB, I-PACK Injection Kit with Drape, REF 18061, for the administrati... Sterilization certificates could not be validated by the supplier Class I
Jun 12, 2024 BAUSCH+LOMB, I-PACK Injection Kit, REF 18060, for the administration of intra... Sterilization certificates could not be validated by the supplier Class I
Aug 11, 2016 25 gauge VersaVit 2.0 Procedure Pack with Mid-Field Illuminator, Product/Part... Vitrectomy cutters have been found not to be operating within the correct pre... Class II
Aug 11, 2016 25 gauge VersaVit 2.0 Vitrectomy Cutter, Product/Part Number 70935, packaged ... Vitrectomy cutters have been found not to be operating within the correct pre... Class II
Aug 11, 2016 25 gauge VersaVit 2.0 Procedure Pack with Photon Wide Field Illuminator, Prod... Vitrectomy cutters have been found not to be operating within the correct pre... Class II
Aug 11, 2016 25 gauge VersaVit 2.0 Core Essentials Procedure Pack, Product/Part Number 700... Vitrectomy cutters have been found not to be operating within the correct pre... Class II
Dec 9, 2013 29ga Oshima Dual Chandelier, Synergetics, inc., length 7.5 ft, sterile / EO, ... Faulty seals on the outer pouch of various, double-pouched, single-use, steri... Class II
Dec 9, 2013 Wide Field Endo Illuminator, Vivid (tm) Endo Illuminator, 20ga, Synergetics, ... Faulty seals on the outer pouch of various, double-pouched, single-use, steri... Class II
Dec 9, 2013 Stiff 25ga Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, ... Faulty seals on the outer pouch of various, double-pouched, single-use, steri... Class II
Dec 9, 2013 27ga ONE-STEP (tm) Awh/Tano Vivid Chandelier, Synergetics, length 8.0 ft, ste... Faulty seals on the outer pouch of various, double-pouched, single-use, steri... Class II
Dec 9, 2013 23ga Wide Field Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile /... Faulty seals on the outer pouch of various, double-pouched, single-use, steri... Class II
Dec 9, 2013 23ga Wide Field Corona Endo Illuminator, Synergetics, inc., length 7.5 ft, st... Faulty seals on the outer pouch of various, double-pouched, single-use, steri... Class II
Dec 9, 2013 25ga Wide Field Corona Endo Illuminator, Synergetics, inc., length 7.5 ft, st... Faulty seals on the outer pouch of various, double-pouched, single-use, steri... Class II
Dec 9, 2013 Standard tubing set, Synergetics, Inc., length 10 ft, sterile / EO, 17570. Pa... Faulty seals on the outer pouch of various, double-pouched, single-use, steri... Class II
Dec 9, 2013 23ga Endo Illuminator (Eckardt Trocar Compatible), Synergetics, inc., length ... Faulty seals on the outer pouch of various, double-pouched, single-use, steri... Class II
Dec 9, 2013 25ga Awh Chandelier, Synergetics, inc., B&L Cannula Compatible, length 8.0 ft... Faulty seals on the outer pouch of various, double-pouched, single-use, steri... Class II
Dec 9, 2013 Vivid (tm) Endo Illuminator, 20ga, Synergetics, inc., length 7.5 ft, sterile ... Faulty seals on the outer pouch of various, double-pouched, single-use, steri... Class II
Dec 9, 2013 25ga Mid-Field Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 56... Faulty seals on the outer pouch of various, double-pouched, single-use, steri... Class II
Dec 9, 2013 25ga Awh Chandelier, Synergetics, inc., length 8.0 ft, sterile / EO, 56.50.25... Faulty seals on the outer pouch of various, double-pouched, single-use, steri... Class II
Dec 9, 2013 "The Corona" Shielded Wide Field Endo Illuminator, Synergetics, inc. 20ga, le... Faulty seals on the outer pouch of various, double-pouched, single-use, steri... Class II
Dec 9, 2013 Endo Illuminator, Synergetics, inc., 20ga, length 7.0 ft, sterile / EO, 56.02... Faulty seals on the outer pouch of various, double-pouched, single-use, steri... Class II
Dec 9, 2013 25ga Aspirating Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 5... Faulty seals on the outer pouch of various, double-pouched, single-use, steri... Class II
Dec 9, 2013 Stiff 25ga Chow Illuminated Pick (Dull), Synergetics, inc., length 8.0 ft, s... Faulty seals on the outer pouch of various, double-pouched, single-use, steri... Class II
Dec 9, 2013 Two-Port Vitrectomy (TPV (tm)) Wide Field High Flow End Irrigator, Synergetic... Faulty seals on the outer pouch of various, double-pouched, single-use, steri... Class II
Dec 9, 2013 23ga Straight Fixed Extended Illuminated Laser Probe, Synergetics, length 7.5... Faulty seals on the outer pouch of various, double-pouched, single-use, steri... Class II
Dec 9, 2013 23ga Aspirating Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 5... Faulty seals on the outer pouch of various, double-pouched, single-use, steri... Class II
Dec 9, 2013 25ga Awh Vivid Chandelier, Synergetics, length 7.5 ft, sterile / EO, 56.54.25... Faulty seals on the outer pouch of various, double-pouched, single-use, steri... Class II
Dec 9, 2013 Chandelier Infusion Cannula, Synergetics, inc., 20ga, length 7.5 ft, sterile ... Faulty seals on the outer pouch of various, double-pouched, single-use, steri... Class II
Dec 9, 2013 27ga ONE-STEP (tm) Endo Illuminator, Synergetics, inc., length 7.5 ft, steri... Faulty seals on the outer pouch of various, double-pouched, single-use, steri... Class II
Dec 9, 2013 Stiff 25ga Wide Field Endo Illuminator, Synergetics, inc. length 7.5 ft, ster... Faulty seals on the outer pouch of various, double-pouched, single-use, steri... Class II
Dec 9, 2013 23ga Chandelier Infusion Cannula, Synergetics, inc., length 8.0 ft, sterile /... Faulty seals on the outer pouch of various, double-pouched, single-use, steri... Class II
Dec 9, 2013 23ga Mid-Field Endo Illuminator, Synergetics length 7.5 ft, sterile / EO, 56.... Faulty seals on the outer pouch of various, double-pouched, single-use, steri... Class II
Dec 9, 2013 25ga Endo Illuminator, Synergetics, inc., length 7.0 ft, sterile / EO, 56.02.... Faulty seals on the outer pouch of various, double-pouched, single-use, steri... Class II
Dec 9, 2013 23ga Chow Illuminated Pick, Synergetics, inc., length 7.5 ft, sterile / EO, 5... Faulty seals on the outer pouch of various, double-pouched, single-use, steri... Class II
Jul 30, 2013 Synergetics 25 gauge Soft Tip Cannula, packaged in 6 units per box. Catalog n... One lot of 25 gauge Soft-Tip Disposable Cannulas are co-mingled with 23 gauge... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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