Device Recalls 2016 — 1,977 Affected Products Indexed

This page indexes 1,977 public recall notices for products in the Device category, issued during 2016 by major government safety regulators. ProductGuru mirrors public regulatory data — this is NOT an exhaustive list, and the agency's own register is the authoritative source. Click any row to verify on the originating agency's official site.

Sources for this index: U.S. Food and Drug Administration (Medical Devices) · last fetched 2026-10-23

What stood out in 2016

An at-a-glance read of this category × year, computed directly from the agency notices indexed below. Every figure here is a count or sum over the same rows you can verify in the table — no editorial, no projection.

• Top hazard reasons: ICU Medical Inc (134), Supplied Directions for Use (DFU) did not contain a recomme… (69), Recall initiated due to inadequate validation/qualification… (65) — most-cited safety concerns across the 1,977 notices in this bucket.
• Most-recent notice in this bucket: Plum 360 Infusion Pump, Software Version 15.02. The infusion pump is capable of delivering fluids for a variety of therapies such as parenteral, enteral, or epidural infusions (Hospira Inc., A Pfizer Company) — issued 2016-12-30 by FDA. Agency rows in this bucket did not include a numeric units-affected count.
• Year-on-year: 1,977 recalls in 2016 vs 1,848 in 2015 — +129 (+7%), more than the prior calendar year in the same category. Year-on-year counts can shift due to agency reporting cadence, not just underlying product safety.
• Regulator distribution: FDA 1977 (100%) — share of the 1977 notices in this bucket attributed to each agency.

Recalled device products in 2016

Chronological, most-recent first. Showing the top 50 by recency; the full 1,977 are available via the agency registers linked at the bottom of the page (and on demand via the ProductGuru API). Each row's verify link opens the official agency notice in a new tab.

The remaining 1,927 device recalls in 2016 are available on the originating agency's register — see the Verify on agency links at the bottom of the page.

Statistics for this period

Top brands by recall count

• ICU Medical, Inc. — 139 recalls
• The Anspach Effort, Inc. — 79 recalls
• Customed, Inc — 65 recalls
• American Surgical Company — 59 recalls
• Zimmer Manufacturing B.V. — 56 recalls

Top hazard reasons

• ICU Medical Inc — 134 notices
• Supplied Directions for Use (DFU) did not contain a recomme… — 69 notices
• Recall initiated due to inadequate validation/qualification… — 65 notices
• Product packaging defective compromising sterility — 59 notices
• As a result of the insufficient sealer calibration data for… — 49 notices

Recalls by agency

• FDA (United States) — 1977 notices

What to do if you own an affected product

Specific remedial instructions — return, repair, refund, disposal, batch lookups — live on the originating agency's official notice, not here. We do not summarise or interpret the instructions because they change over time (recalls get amended, expanded, or terminated). Follow the View on … link in the row above for the product you own.

General guidance when a product you own appears on a recall list:

• Stop using the item immediately.
• Check the official agency notice for batch / model / serial numbers; only specific units may be affected.
• Keep proof of purchase if you have it.
• Follow the return / refund / repair instructions in the official notice, not here.
• If you believe you have been exposed to a health risk from the product, consult a qualified healthcare professional. This page reports what agencies published; it is not medical advice.

About this index

ProductGuru maintains a free, ad-supported index of public recall notices from major government safety regulators worldwide. We re-fetch each source on a regular schedule and rebuild category roundup pages weekly, so a recall that was added or updated after this page was last generated will appear in the next refresh. The last fetched date in the source row above tells you when this page was last regenerated.

Jurisdictions currently covered: United States (CPSC, FDA Food, FDA Medical Devices), Canada (Health Canada), and the European Union (EU Safety Gate / RAPEX, covering all EU member states plus Iceland, Liechtenstein, and Norway). We do not currently index pharmaceutical drug recalls on consumer-facing pages.

We exist because consumer recalls are otherwise hard to find unless you know exactly which agency to ask. A consumer who bought a product two years ago, in a different country, from a re-seller, will almost never stumble across the original notice. Putting every category × year on its own URL — with the agency deep-link on each row — lets ordinary search queries surface the recall when it matters.

Verify on the originating agency

• FDA — U.S. Food and Drug Administration (Medical Devices): open FDA recall register →

We aggregate publicly-listed recalls; this is NOT comprehensive. Specific recall instructions are on the agency's official notice. This is NOT legal, medical, or safety advice. ProductGuru indexes public regulatory data; we are not a primary source. Always verify on the linked official register before acting on this information. If you have a safety concern about a product you own, contact the agency or a qualified professional. This page has no purchase links and no affiliate links — we do not drive shopping traffic to products that are the subject of safety recalls.