Exact FDA event identifier

Event 82629

6 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: April 08, 2019
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Compass Health Brands (Corporate Office)

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

6 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 6

MediPress pneumatic compression system, Half Leg-Segmental Gradient, Model #6102-S

Z-1343-2019

Recall number: Z-1343-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Compass Health Brands (Corporate Office)
Quantity: Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Product design change did not receive proper premarket clearance and lacks a 510 (k)

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product design change did not receive proper premarket clearance and lacks a 510 (k)

Code information

All Serial Numbers/Lots

Distribution pattern

Domestically to AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TN, KY, TX, UT, VA, WA, WI & WY Internationally to Canada

device · product 2 of 6

MediPress pneumatic compression system Full Leg (Medium)-Segmental Gradient, Model #6103M-S

Z-1344-2019

Recall number: Z-1344-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Compass Health Brands (Corporate Office)
Quantity: Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Product design change did not receive proper premarket clearance and lacks a 510 (k)

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product design change did not receive proper premarket clearance and lacks a 510 (k)

Code information

All Serial Numbers/Lots

Distribution pattern

Domestically to AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TN, KY, TX, UT, VA, WA, WI & WY Internationally to Canada

device · product 3 of 6

MediPress pneumatic compression system Full Arm (Medium)-Segmental Gradient, Model #6104M-S

Z-1345-2019

Recall number: Z-1345-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Compass Health Brands (Corporate Office)
Quantity: Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Product design change did not receive proper premarket clearance and lacks a 510 (k)

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product design change did not receive proper premarket clearance and lacks a 510 (k)

Code information

All Serial Numbers/Lots

Distribution pattern

Domestically to AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TN, KY, TX, UT, VA, WA, WI & WY Internationally to Canada

device · product 4 of 6

MediPress pneumatic compression system Full Leg (Long)-Segmental Gradient, Model #6103L-S

Z-1346-2019

Recall number: Z-1346-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Compass Health Brands (Corporate Office)
Quantity: Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Product design change did not receive proper premarket clearance and lacks a 510 (k)

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product design change did not receive proper premarket clearance and lacks a 510 (k)

Code information

All Serial Numbers/Lots

Distribution pattern

Domestically to AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TN, KY, TX, UT, VA, WA, WI & WY Internationally to Canada

device · product 5 of 6

MediPress pneumatic compression system Full Leg (Short)-Segmental Gradient, Model #6103S-S

Z-1347-2019

Recall number: Z-1347-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Compass Health Brands (Corporate Office)
Quantity: Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Product design change did not receive proper premarket clearance and lacks a 510 (k)

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product design change did not receive proper premarket clearance and lacks a 510 (k)

Code information

All Serial Numbers/Lots

Distribution pattern

Domestically to AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TN, KY, TX, UT, VA, WA, WI & WY Internationally to Canada

device · product 6 of 6

MediPress pneumatic compression system Full Arm (Short)-Segmental Gradient, Model #6104S-S

Z-1348-2019

Recall number: Z-1348-2019
Initiated: April 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Compass Health Brands (Corporate Office)
Quantity: Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Product design change did not receive proper premarket clearance and lacks a 510 (k)

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product design change did not receive proper premarket clearance and lacks a 510 (k)

Code information

All Serial Numbers/Lots

Distribution pattern

Domestically to AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TN, KY, TX, UT, VA, WA, WI & WY Internationally to Canada