Reported Aug 23, 2017 · Terminated

Encore(TM) 26 Inflation Device, REF Catalog Nos.: (a) H74904526011, (b) M001151050, (c) M00566670, (d) M0067101140

Boston Scientific Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Boston Scientific Corporation · 100 Boston Scientific Way · Marlborough, MA · 01752-1234

- Encore(TM) 26 Inflation Device
- REF Catalog Nos.: (a) H74904526011
- (b) M001151050
- (c) M00566670
- (d) M0067101140

Lot codes and dates: Serial Numbers
65 of 65 codes
(a) 19563006
19587644
19623142
19650458
19704550
19725489
19769215
20054530
20077271
20083051
20127928
20159518
20202728
20206930
20242335
20285571
20309573
20309574
20336380
20394218
20423644
20423645
20456071
20481170
20534557 (b) 19640750
19667072
19704551
19755302
19755307
19785021
19808183
20030825
20060033
20087896
20117909
20159601
20171449
20206929
20233700
20256035
20279769
20303751
20336385
20336386
20364928
20364929
20364930
20423650
20472532
20493563
20507373
20534581 (c) 20157078
19623019
19755304
20056496
20146417
20264032
20456079 (d) 19594194
19717352
19808180
Amount recalled: 305,779 units

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Boston Scientific (BSC) has received complaints for cracked trays on the Encore device.

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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135 in total.