Mistakes 1 and 2: SKU-level tracking and FIFO
The first mistake is accepting SKU-level inventory. If your 3PL tracks quantity by item but not lot, serial and expiration, every recall becomes a forensic exercise and every audit question takes days.
The second is running FIFO when you need FEFO. First in, first out ships the oldest receipt, which is not always the earliest expiry, especially after returns, transfers or split shipments from your manufacturer. Expired product on a shelf is a write-off. Expired product at a hospital is a complaint, a credit and a damaged relationship. Require FEFO allocation and customer-specific minimum remaining shelf-life rules in the system, not in someone's head.
Mistake 3: No quality agreement
A handshake and a rate card are not a quality agreement. Without one, nobody has written down who approves quarantine releases, how fast complaints are forwarded, how deviations are reported, what records are kept and for how long, or how change control works when the 3PL moves your product or changes its software.
Under the FDA's quality management system regulation, your 3PL is a supplier you are responsible for controlling. The quality agreement is how you do it. Sign it before go-live.
Mistake 4: Letting holds live in spreadsheets
A hold that exists in a spreadsheet, an email or a sticky note is a hold that will eventually be shipped. Quarantine must be system-enforced, so the warehouse management system will not allocate held lots, and physical, so held product sits in a segregated location.
Test this during onboarding: place a hold on a lot and try to place an order against it. If the order allocates, you have found a gap.
Mistake 5: Ignoring hospital receiving rules
Health systems and distributors have routing guides, EDI requirements, labeling rules and dock procedures, and they enforce them with chargebacks and rejected deliveries. Brands often onboard a 3PL for DTC, then add a hospital customer and discover the warehouse cannot send an advance ship notice or build compliant pallets.
If B2B healthcare is in your plan within the next year, qualify your 3PL for it now.
Mistakes 6 and 7: Registration as proof of quality, returns as restock
FDA establishment registration tells you a facility performs certain activities and has registered them. It does not tell you that its processes are well controlled. Conversely, a 3PL that only stores and ships finished devices may not need to register at all.
Ask what activities the provider performs for you, whether any require registration, and then evaluate its processes on their own merits through an audit or assessment.
The seventh mistake is treating returns as restock. When returns flow straight back to available inventory, you lose control of product condition and visibility into complaints. A device-focused return process quarantines, inspects, captures lot and serial, flags complaint indicators and waits for a disposition you control.
Mistake 8: Never running a mock recall
A recall procedure that has never been tested is a hypothesis. Run a mock recall with your 3PL at onboarding and periodically afterward. Pick a lot, request a consignee report, check it against your ERP and time the whole exercise.
The point is not to pass. The point is to find the missing field, the manual step or the person who does not know the process while there is no real pressure.
Mistake 9: Overlooking dangerous goods and temperature
Powered devices with lithium batteries and products with labeled storage conditions both create rules that a general warehouse may not follow consistently. Battery SKUs shipped on the wrong service level get returned or fined. Temperature-sensitive products stored in an unmonitored mezzanine can drift outside labeled conditions without anyone knowing.
List every SKU with a battery or a temperature requirement, and confirm the 3PL has a documented, SKU-specific handling rule for each one.
How to audit your current setup
If you already work with a 3PL, you can check for most of these mistakes in an afternoon. Ask for four things: an on-hand inventory report by lot and expiry, a consignee report for one lot shipped in the last quarter, the list of current holds with reasons and approvers, and the last three months of returns by reason code and disposition.
Then compare what you received against your own records. Missing lot fields, holds with no documented approver, returns restocked without a disposition record or a consignee report that took days to produce all point to specific fixes. Raise them formally under your quality agreement, agree on corrective actions with due dates, and follow up. Small gaps found during a calm quarter are much cheaper than the same gaps discovered during a recall or an inspection.
One more trap sits underneath all nine: choosing on pick fee alone. Rate cards are easy to compare and quality systems are not. Compare total cost, including expired write-offs, chargebacks and recall effort, before you compare pick fees.
Frequently asked questions
What is the biggest mistake when choosing a medical device 3PL?
The biggest mistake is choosing a provider that tracks inventory only by SKU. Without lot, serial and expiry data at every touch, recalls, audits and shelf-life management all become slow, manual and error-prone.
Do I need a quality agreement with my 3PL?
Yes. A quality agreement defines responsibilities for holds, complaints, deviations, records and change control, and it is the main tool for controlling a 3PL as a supplier under your quality management system.
How often should I run a mock recall with my 3PL?
Run one at onboarding and then on a regular schedule, commonly at least annually. Many teams also run one after major changes, such as a system upgrade or a move to a new site.