Portable Suction Pump, (a) Style 758010
Medical device recall Z-2995-2018. Published in FDA’s Enforcement Report on Sep 19, 2018.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Sep 19, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 1443 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
The care-e-vac(R)3 Battery/AC Powered Portable Aspirator battery terminal may come in contact with the pump causing an electric short leading to damage to wiring and resulting in loss of function or an inoperable unit under battery power.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Portable Suction Pump, (a) Style 758010, Model CARE-E-VAC 3, Ohio Medical LLC; (b) Style 758000, Model CARE-E-VAC 3, Ohio Medical LLC The care-e-(R)3 is a portable medical aspirator used to suction fluids or foreign bodies from a patient. The primary intended use is to aspirate saliva, mucous, vomitus or other aspirant from the mouth or airway to allow adequate respiration or ventilation of the patient.
1443 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
(a) style 758010 Serial Numbers: CDS5000 CDS5001 CDS5002 CDS5003 CDS5004 CDS5005 CDS5006 CDS5007 CDS5008 CDS5009 CDS5010 CDS5011 CDS5012 CDS5013 CDS5014 CDS5015 CDS5016 CDS5017 CDS5018 CDS5019 CDS5020 CDS5021 CDS5022 CDS5023 CDS5024…
Every code shown here, 1,998 characters
(a) style 758010 Serial Numbers: CDS5000 CDS5001 CDS5002 CDS5003 CDS5004 CDS5005 CDS5006 CDS5007 CDS5008 CDS5009 CDS5010 CDS5011 CDS5012 CDS5013 CDS5014 CDS5015 CDS5016 CDS5017 CDS5018 CDS5019 CDS5020 CDS5021 CDS5022 CDS5023 CDS5024 CDS5025 CDS5026 CDS5027 CDS5028 CDS5029 CDS5030 CDS5031 CDS5032 CDS5033 CDS5034 CDS5035 CDS5036 CDS5037 CDS5038 CDS5039 CDS5040 CDS5041 CDS5042 CDS5043 CDS5044 CEV3X0076 CEV3X0077 CEV3X0078 CEV3X0079 CEV3X0080 CEV3X0081 CEV3X0082 CEV3X0083 CEV3X0084 CEV3X0085 CEV3X0086 CEV3X0087 CEV3X0088 CEV3X0089 CEV3X0090 CEV3X0091 CEV3X0092 CEV3X0093 CEV3X0094 CEV3X0095 CEV3X0096 CEV3X0097 CEV3X0098 CEV3X0099 CEV3X0100 CEV3X0101 CEV3X0102 CEV3X0103 CEV3X0104 CEV3X0105 CEV3X0106 CEV3X0107 CEV3X0108 CEV3X0109 CEV3X0110 CEV3X0111 CEV3X0112 CEV3X0113 CEV3X0114 CEV3X0115 CEV3X0116 CEV3X0117 CEV3X0118 CEV3X0119 CEV3X0120 CEV3X0121 CEV3X0122 CEV3X0123 CEV3X0124 CEV3X0125 CEV3X0176 CEV3X0177 CEV3X0178 CEV3X0179 CEV3X0180 CEV3X0181 CEV3X0182 CEV3X0183 CEV3X0184 CEV3X0185 CEV3X0186 CEV3X0187 CEV3X0188 CEV3X0189 CEV3X0190 CEV3X0191 CEV3X0192 CEV3X0193 CEV3X0194 CEV3X0195 CEV3X0196 CEV3X0197 CEV3X0198 CEV3X0199 CEV3X0200 CEV3X0201 CEV3X0202 CEV3X0203 CEV3X0204 CEV3X0205 CEV3X0206 CEV3X0207 CEV3X0208 CEV3X0209 CEV3X0210 CEV3X0211 CEV3X0212 CEV3X0213 CEV3X0214 CEV3X0215 CEV3X0216 CEV3X0217 CEV3X0218 CEV3X0219 CEV3X0220 CEV3X0221 CEV3X0222 CEV3X0223 CEV3X0224 CEV3X0225 CEV3X0462 CEV3X0463 CEV3X0464 CEV3X0465 CEV3X0466 CEV3X0467 CEV3X0468 CEV3X0469 CEV3X0470 CEV3X0471 CEV3X0472 CEV3X0473 CEV3X0474 CEV3X0475 CEV3X0476 CEV3X0477 CEV3X0478 CEV3X0479 (b) style 758000 Serial Numbers: CDS0081 CDS0082 CDS0083 CDS0084 CDS0085 CDS0086 CDS0087 CDS0088 CDS0089 CDS0090 CDS0091 CDS0092 CDS0093 CDS0094 CDS0095 CDS0096 CDS0097 CDS0098 CDS0099 CDS0100 CDS0101 CDS0102 CDS0103 CDS0104 CDS0105 CDS0106 CDS0107 CDS0108 CDS0109 CDS0110 CDS0111 CDS0112 CDS0113 CDS0114 CDS0115 CDS0116 CDS0117 CDS0118 CDS0119 CDS0120 CDS0121 CDS0122 CDS0123 CDS0124 CDS0125 CDS0126 CDS0127 CDS0128 CDS0129…
FDA’s list runs to 13,183 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
US Nationwide Distribution and internationally to countries: Canada, Saudi Arabia, and United Arab Emirates.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Aug 14, 2018.
- FDA classified it on Sep 7, 2018.
- FDA’s Enforcement Report published it on Sep 19, 2018.
- FDA terminated it on Dec 15, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Ohio Medical Corporation, of Gurnee, IL.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 13,183 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.