CLASS II Device recall · Reported 15 Jan 2020 · FDA Enforcement Report

Cochlear Baha 5 Sound Processor Tamper Proof Battery Door recalled

Cochlear Americas is recalling Cochlear Baha 5 Sound Processor Tamper Proof Battery Door, distributed in 10 states. The recall was initiated on 18 Dec 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart Number: P1129017 UDI Number: 09321502041096 Lot Number: COH1253733

Quantity recalled50 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0792-2020
FDA event ID: 83970
Recalling firm: Cochlear Americas, Centennial, CO
Classification: Class II
Status: Terminated
Recall initiated: 18 Dec 2018
FDA classified: 9 Jan 2020
Reported: 15 Jan 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Hearing Aids

Timeline

18 Dec 2018	Recall initiated by company
9 Jan 2020	Classified by FDA	+387 days
15 Jan 2020	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Product was packaged with the Incorrect tamper proof battery door.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Cochlear Baha 5 Sound Processor Tamper Proof Battery Door (3 pcs.)

Where it was distributed

Domestic: CA, FL, IL, IN, MA, MO, NY, SD, TN, and TX OUS Regions; Asia Pacific (APAC), and Europe, The Middle East and Africa (EMEA)

California Florida Illinois Indiana Massachusetts Missouri New York South Dakota Tennessee Texas

Questions about this recall

Why was it recalled?

Product was packaged with the Incorrect tamper proof battery door.

Which lots are affected?

Part Number: P1129017 UDI Number: 09321502041096 Lot Number: COH1253733

Where was it sold?

Domestic: CA, FL, IL, IN, MA, MO, NY, SD, TN, and TX OUS Regions; Asia Pacific (APAC), and Europe, The Middle East and Africa (EMEA)

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Cochlear Americas

All 3

Reported	Class	Recall	Company	Reason	Where
29 Jul 2015Device	CLASS II	Cochlear Nucleus Sterile Silicone Template recalled by Cochlear Americas	Cochlear Americas	Sterility	Nationwide
11 Jun 2014Device	CLASS II	Cochlear Baha Soft tissue gauge Reusable instrument used recalled	Cochlear Americas	Foreign Material	Nationwide

Other Hearing Aids recalls

All 22

Reported	Class	Recall	Company	Reason	Where
24 Jun 2026Device	CLASS II	Medline convenience kits: Discectomy Pack DYNJ86476B Ear recalled	Medline Industries	Device Malfunction	Nationwide
13 May 2026Device	CLASS II	See RES for full list recalled by Medline Industries	Medline Industries	Sterility	Nationwide
6 May 2026Device	CLASS II	HiResolution" Bionic Ear System M Zn-Air Battery Pak recalled	Advanced Bionics	Device Malfunction	Nationwide
25 Feb 2026Device	CLASS II	Medline Convenience Kits: Chp Cochlear Supplement Cds recalled	Medline Industries	Sterility	Nationwide
4 Feb 2026Device	CLASS II	Medline medical procedure convenience kits labeled as recalled	Medline Industries	Device Malfunction	Nationwide