FDA device enforcement
Daig Livewire Steerable, Product Number 401582; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product
Class IIReported ongoing
Distribution: US Nationwide and the countries of Israel and Canada.
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Stryker Sustainability Solutions recall records
40 reported ongoing
41 records in this archive. Latest source date Aug 19, 2026.
FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
Records and reported status
Official source for Daig Livewire Steerable, Product Number 401582; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA device enforcement
Daig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product
Class IIReported ongoing
Distribution: US Nationwide and the countries of Israel and Canada.
FDA device enforcement
Daig Livewire Steerable, Product Number 401652; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product
Class IIReported ongoing
Distribution: US Nationwide and the countries of Israel and Canada.
FDA device enforcement
Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product
Class IIReported ongoing
Distribution: US Nationwide and the countries of Israel and Canada.
FDA device enforcement
Daig Livewire Steerable, Product Number 401905; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product
Class IIReported ongoing
Distribution: US Nationwide and the countries of Israel and Canada.
FDA device enforcement
Daig Livewire Steerable, Product Number 401908; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product
Class IIReported ongoing
Distribution: US Nationwide and the countries of Israel and Canada.
FDA device enforcement
Daig Livewire Steerable, Product Number 401914; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product
Class IIReported ongoing
Distribution: US Nationwide and the countries of Israel and Canada.
FDA device enforcement
Daig Livewire Steerable, Product Number 401915; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product
Class IIReported ongoing
Distribution: US Nationwide and the countries of Israel and Canada.
FDA device enforcement
Daig Livewire Steerable, Product Number 401923; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product
Class IIReported ongoing
Distribution: US Nationwide and the countries of Israel and Canada.
FDA device enforcement
Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product
Class IIReported ongoing
Distribution: US Nationwide and the countries of Israel and Canada.
FDA device enforcement
Daig Livewire Steerable BDB, Product Number 401918, REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product
Class IIReported ongoing
Distribution: US Nationwide and the countries of Israel and Canada.
FDA device enforcement
Medtronic Marinr Steerable, Product Number 72402; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product
Class IIReported ongoing
Distribution: US Nationwide and the countries of Israel and Canada.
FDA device enforcement
Stryker Sustainability Solution Color Cuff 24" (Yellow) Quick Connect Dual Port Single Bladder REF 5921-024-235 Stryker Sustainability Solution Color Cuff 18" (Red), Quick Conne...
Due to potential for tourniquet cuffs to detach from the bladder at the welding connection and result in the cuff not being able to maintain pressure.
Class IIReported ongoing
Distribution: U.S.: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NY, OHJ, OK, OR, PA SC, SD, TN, TX, VA, VT, and WA....
FDA device enforcement
HARMONIC FOCUS Shears + Adaptive Tissue Technology, 9 cm Length REF: HAR9F, Reprocessed Device for Single Use, STERILEEO, RX ONLY
Due to manufacturing issue, reprocessed shears, may become stuck in the "on position" resulting in continuous activation.
Class IIReported ongoing
Distribution: US Nationwide distribution and OUS (foreign) to country of: Canada.
FDA device enforcement
Disposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5A
Disposable 5 lead cable and lead wire system package that should contain lead systems, lead telemetry systems and a dual connect cable, may in fact contain, different ECG Leads, which are not approved for reprocessing, but that may have been reprocessed, wh...
Class IIReported ongoing
Distribution: US Nationwide distribution in the states of FL, WY, AZ, CA, LA, TX, MI, OR, CO, MS, TN, WI.
FDA device enforcement
REF: 60-7070-005, Zimmer, Tourniquet Cuff 30" (Blue), Luer-Lock Dual Port, single Bladder, RxOnly
Mislabeling; tourniquet cuff packaging labeled as dual port single bladder but contains a tourniquet cuff single port single bladder.
Class IIReported ongoing
Distribution: US Nationwide distribution in the states of CA, CO, IL, MI, OR, WI.
FDA device enforcement
Stryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter, REF: D134301, ELECTRODES: 22, spacing:2-6-2MM, Length 115 cm, STERILE.EO, Rx Only
Diagnostic electrophysiology (EP) catheters do not meet testing requirements.
Class IIReported ongoing
Distribution: International distribution to the country of Japan.
FDA device enforcement
HoverMatt, 39" W x 78" L, REF: HM39SPU-B
39-inche-wide inflatable air transfer mattress packages contain 34-Inch-wide mattresses, so there may be a decreased surface area available to distribute the patient's weight across, which may increase the effort exerted by staff for a lateral patient trans...
Class IIReported ongoing
Distribution: US: WI, ID, CA, FL, HI, MD, RI, AZ, MA, GA, IL
FDA device enforcement
REF 5065, Kendall, Impad Rigid Sole Foot Cover, Regular Pair ,
Through complaint surveillance, it was identified that reprocessed Deep vein thrombosis (DVT) Compression Sleeves may be mislabeled and/or mispackaged.
Class IIReported ongoing
Distribution: US: WA OUS: None
FDA device enforcement
Color Cuff Single Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-135; Color Cuff Dual Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-235; C...
Increased incidence of disposable tourniquet cuffs "not able to achieve desired pressure" and "not holding pressure" due to 1) Cuff fabric tearing during use, and 2) Pinched or unseated O-ring at the connection between the cuff, disposable fill line, and/or...
Class IIReported ongoing
Distribution: US: WI, MD, NY, PA, WA, CO, GA, FL, OH, NC, TX, NJ, OR, MT, CA, RI, SC, NE, MI, LA, OK, SD, AL, VA, MS, WV, AZ, KY, IL, AR, ME, ND, MO, KS, HI, NH, AK, TN, IA, MN, IN, NV, MA, I...
Reasons in these listed records
- Incomplete seals on sterile product
- Due to potential for tourniquet cuffs to detach from the bladder at the welding connection and result in the cuff not being able to maintain pressure.
- Due to manufacturing issue, reprocessed shears, may become stuck in the "on position" resulting in continuous activation.
- Disposable 5 lead cable and lead wire system package that should contain lead systems, lead telemetry systems and a dual connect cable, may in fact contain, different ECG Leads, which are not approved for reprocessing, but that may have been reprocessed, which may lead to devi...
These examples come from this result page and are not a ranking of every recall reason.
Checking Stryker Sustainability Solutions
Is there a recall on stryker sustainability solutions right now?
This archive contains 41 records, including 40 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.
How do I check my package or product?
Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.
Does a matching name mean every item is included?
A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.
What if the search finds no matching record?
This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.
Where can I find older records?
Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.