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.
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.
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
These labels are deterministic app interpretations, not FDA categories.
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
Code information
Lot Numbers: 313406, 313447, 313164, 313165 & 313166
Distribution pattern
IL & OH distributors
device · product 2 of 14
MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR AND 7 FT. OXYGEN TUBING, REF CPRM1116
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
These labels are deterministic app interpretations, not FDA categories.
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
These labels are deterministic app interpretations, not FDA categories.
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
Code information
Lot Number: 313238
Distribution pattern
IL & OH distributors
device · product 4 of 14
MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, FILTER, CO2 AND 7 FT. OXYGEN TUBING, REF CPRM1116FC
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
These labels are deterministic app interpretations, not FDA categories.
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
Code information
Lot Numbers: 313444 & 313239
Distribution pattern
IL & OH distributors
device · product 5 of 14
MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, PEEP VALVE AND 7 FT. OXYGEN TUBING, REF CPRM1116P
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
These labels are deterministic app interpretations, not FDA categories.
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
Code information
Lot Number: 313545
Distribution pattern
IL & OH distributors
device · product 6 of 14
MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, PEEP VALVE, CO2 AND 7 FT. OXYGEN TUBING, REF CPRM1116PC
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
These labels are deterministic app interpretations, not FDA categories.
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
Code information
Lot Number: 313235
Distribution pattern
IL & OH distributors
device · product 7 of 14
MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK 5, BAG RESERVOIR, PEEP VALVE AND 7 FT. OXYGEN TUBING, REF CPRM1116PD5
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
These labels are deterministic app interpretations, not FDA categories.
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
Code information
Lot Numbers: 313326, 313436 & 313049
Distribution pattern
IL & OH distributors
device · product 8 of 14
MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR AND 7 FT. OXYGEN TUBING, REF CPRM1126
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
These labels are deterministic app interpretations, not FDA categories.
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
Code information
Lot Numbers: 313546, 313717, 313176 & 313772
Distribution pattern
IL & OH distributors
device · product 9 of 14
MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, CO2 AND 7 FT. OXYGEN TUBING, REF CPRM1126C
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
These labels are deterministic app interpretations, not FDA categories.
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
Code information
Lot Numbers: 313321, 313437, 313080 & 313193
Distribution pattern
IL & OH distributors
device · product 10 of 14
MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, FILTER AND 7 FT. OXYGEN TUBING, REF CPRM1126F
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
These labels are deterministic app interpretations, not FDA categories.
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
Code information
Lot Numbers: 313471, 313627 & 313696
Distribution pattern
IL & OH distributors
device · product 11 of 14
MEDLINE ADULT MANUAL RESUSCITATOR WITH LARGE ADULT MASK, TUBE RESERVOIR, FILTER AND 7 FT. OXYGEN TUBING, REF CPRM1126FL
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
These labels are deterministic app interpretations, not FDA categories.
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
Code information
Lot Numbers: 313363 & 313738
Distribution pattern
IL & OH distributors
device · product 12 of 14
MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, FILTER, PEEP VALVE AND 7 FT. OXYGEN TUBING, REF CPRM1126FP
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
These labels are deterministic app interpretations, not FDA categories.
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
Code information
Lot Numbers: 313323, 313355, 313739, 313031, 313093, 313190 & 313272
Distribution pattern
IL & OH distributors
device · product 13 of 14
MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, FILTER, PEEP VALVE, CO2 AND 7 FT. OXYGEN TUBING, REF CPRM1126FPC
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
These labels are deterministic app interpretations, not FDA categories.
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
Code information
Lot Number: 313315
Distribution pattern
IL & OH distributors
device · product 14 of 14
MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, PEEP VALVE AND 7 FT. OXYGEN TUBING, REF CPRM1126P
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
These labels are deterministic app interpretations, not FDA categories.
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
