Delta Med SpA

Complete recall history across all FDA and CPSC categories — 11 total recalls

Delta Med SpA 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 (11)

FDA medical device enforcement actions by Delta Med SpA

Date Product Reason Class
Jun 21, 2021 DELTAVEN Y, Safety I.V. Catheter in Pur with closed system a) REF 3832072 b... Problems related to the sterilization of the medical devices; possible missin... Class II
Jun 21, 2021 NEO DELTA SELFSAFE PUR 1, I.V. Catheter, REF 3718122 Problems related to the sterilization of the medical devices; possible missin... Class II
Jun 21, 2021 DELTAVEN FASTFLASH, Safety I.V. Catheter in Pur with closed system: a) REF 3... Problems related to the sterilization of the medical devices; possible missin... Class II
Jun 21, 2021 DELTAVEN Safety I.V. Catheter in Pur with closed system: a) REF 3836272 b) ... Problems related to the sterilization of the medical devices; possible missin... Class II
Jun 21, 2021 WOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF PIV2210W c)... Problems related to the sterilization of the medical devices; possible missin... Class II
Jun 21, 2021 NEO DELTA SELFSAFE PUR T, I.V. Catheter: a) REF 3738522 b) REF 3738822 Problems related to the sterilization of the medical devices; possible missin... Class II
Jun 21, 2021 DELTAVEN Y DNL Safety I.V. Catheter in Pur with closed system: a) REF 383257... Problems related to the sterilization of the medical devices; possible missin... Class II
Jun 21, 2021 NEO DELTA Self Safe T, I.V. catheter of PUR a) REF 3779422 b) REF 3769522 ... Problems related to the sterilization of the medical devices; possible missin... Class II
Jun 21, 2021 NEO DELTA SELFSAFE PUR T, I.V. Catheter: Problems related to the sterilization of the medical devices; possible missin... Class II
Jun 21, 2021 NEO DELTA Self Safe, I.V. Catheter REF 3738222 Problems related to the sterilization of the medical devices; possible missin... Class II
Jun 21, 2021 NEO DELTA Self Safe 1, I.V. Catheter with PUR REF 3708122, Lot 00A1160627 5... Problems related to the sterilization of the medical devices; possible missin... 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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