🏥

Medical Devices Recalls

Medical equipment, implants, and diagnostic devices

38,779 Total Recalls

Prism Medical P-300 Portable Consumer Lift; PN 303050, 303050R, and 303051; weight specification 300 lbs. /136 kg.

ErgoSafe Products, LLC (DBA) Prism Medical

Class I - Dangerous

Drive shaft and over speed arm may simultaneously fail potentially resulting in a patient falling during use

Sep 8, 2015 Other Medical Devices Nationwide View Details →

HARMONIC ACE+ 7 Laparoscopic Shears with Advanced Hemostasis (23cm, 36cm, 45cm length), Ethicon Endo-Surgery. Indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired.

Ethicon Endo-Surgery

Class I - Dangerous

Complaints of holes in Tyvek which can compromise the sterile barrier provided by the packaging.

Sep 23, 2015 Other Medical Devices Nationwide View Details →

10-Panel Pipette Drug Screen, Item No. PSP-10M These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.

Ameditech

Class I - Dangerous

Ameditech is recalling drug abuse tests because they have shown reduced reactivity.

Oct 20, 2015 Diagnostic Equipment Nationwide View Details →

CIVCO Biopsy Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REFs 10787043, 11001906, 11001906(CMI), 613-247, 613-247(CMI), 620-116, 639-014, 639-016, 639-021, 639-024, 639-025, 639-026, 639-027, 639-033, 639-035, 639-047, 639-051, 658-001, 667-106, 667-106(CMI), 667-127, 672-001, 698-007, 698-009, 698-013, 698-015, 742-397-T, 742-416, and H48392LT. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.

Civco Medical Instruments Co.

Class I - Dangerous

Sterility of the product cannot be assured.

Oct 21, 2015 Diagnostic Equipment Nationwide View Details →

CLIA RDTC 12-Panel Cup and CLIA RDTC 12-Panel Cup (w/Adulteration), Item No. CLIA-RDTC-12 These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.

Ameditech

Class I - Dangerous

Ameditech is recalling drug abuse tests because they have shown reduced reactivity.

Oct 20, 2015 Diagnostic Equipment Nationwide View Details →

CIVCO Tracking Bracket Starter Kit, Reusable non-sterile PercuNav tracking bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REF 667-132. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.

Civco Medical Instruments Co.

Class I - Dangerous

Sterility of the product cannot be assured.

Oct 21, 2015 Diagnostic Equipment Nationwide View Details →

DrugSmart 11 Test Cup, Item No. 61127D; DrugSmart 12 Test Cup (Multi & BUP), Item No. 61210D; DrugSmart 9 Test Cup (BUP), Item No. 60960D; DrugSmart Cup 10, Item No. 61093D-3C These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.

Ameditech

Class I - Dangerous

Ameditech is recalling drug abuse tests because they have shown reduced reactivity.

Oct 20, 2015 Diagnostic Equipment Nationwide View Details →

THERMO FISHER 6 DRUG CASSETTE, Item No. MTPA-6MBAU, MTPA-8MBAU These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use. ¿¿¿

Ameditech

Class I - Dangerous

Ameditech is recalling drug abuse tests because they have shown reduced reactivity.

Oct 20, 2015 Diagnostic Equipment Nationwide View Details →

Synthes Application Instrument for Sternal ZIPFIX. Indications for use include primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion.

Synthes (USA) Products

Class I - Dangerous

Certain lots of the Application Instrument for Sternal ZIPFIX that were previously recalled on August 19, 2015 and subsequently repaired and returned to customers between August 26, 2015 and September 23, 2015. The screws on the repaired instruments have the potential to break or loosen. DePuy Synthes is requesting the return of the repaired device in exchange for a new device.

Oct 19, 2015 Surgical Instruments View Details →

11 Panel Dip Card (OPI 2000), Item No. 11125AA2K; 11 Panel Dip Card (OPI 300) w/Adult, Item No. 11125AA These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.

Ameditech

Class I - Dangerous

Ameditech is recalling drug abuse tests because they have shown reduced reactivity.

Oct 20, 2015 Diagnostic Equipment Nationwide View Details →

Fresenius 132 Gallon Dry Acid Dissolution Unit, P/N 160147. For Use in the Preparation of acid concentrate for hemodialysis.

Fresenius Medical Care Renal Therapies Group

Class I - Dangerous

Dissolution units and replacement motors units do not provide full thermal protection for both the Main and Starter coils resulting in the generation of smoke and/or potentially lead to fire.

Oct 23, 2015 Other Medical Devices Nationwide View Details →

CIVCO Sales Demo Kit. REF DEMOGPGUIDE Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.

Civco Medical Instruments Co.

Class I - Dangerous

Sterility of the product cannot be assured.

Oct 21, 2015 Diagnostic Equipment Nationwide View Details →

Prism Medical C-300 Consumer Ceiling Lift; PN 330050, 330050R, 330053, 330053R, and 330057; weight specification 300 lbs. /136 kg. Lifting aid used by health care professionals to lift, position, and transfer clients or disabled family members.

ErgoSafe Products, LLC (DBA) Prism Medical

Class I - Dangerous

Drive shaft and over speed arm may simultaneously fail potentially resulting in a patient falling during use

Sep 8, 2015 Other Medical Devices Nationwide View Details →

Fresenius Modified Mixer Motor (for 132 Gallon Dissolution Units), P/N 160075. For Use in the Preparation of acid concentrate for hemodialysis.

Fresenius Medical Care Renal Therapies Group

Class I - Dangerous

Dissolution units and replacement motors units do not provide full thermal protection for both the Main and Starter coils resulting in the generation of smoke and/or potentially lead to fire.

Oct 23, 2015 Other Medical Devices Nationwide View Details →

12-Panel Dip Drug Screen with adulterant, Item No. PSDA-12BUP These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.

Ameditech

Class I - Dangerous

Ameditech is recalling drug abuse tests because they have shown reduced reactivity.

Oct 20, 2015 Diagnostic Equipment Nationwide View Details →

CIVCO Needle Guide Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REFs 674-030, 674-030-T, 674-031, 674-031-T, 674-035, 674-036, 674-044, 674-052, 674-059, 674-061. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.

Civco Medical Instruments Co.

Class I - Dangerous

Sterility of the product cannot be assured.

Oct 21, 2015 Diagnostic Equipment Nationwide View Details →

Cyberonics Vagus Nerve Stimulator (VNS) Therapy AspireSR Generator, Model 106

Cyberonics

Class I - Dangerous

Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the 'Verify Heartbeat Detection' feature and exhibit potential for decreased battery longevity.

Oct 7, 2015 Other Medical Devices View Details →

Micro Screen 6 Panel Cup with Adult (AU), Item No. MSCA-6MBAU These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use. ¿¿¿

Ameditech

Class I - Dangerous

Ameditech is recalling drug abuse tests because they have shown reduced reactivity.

Oct 20, 2015 Diagnostic Equipment Nationwide View Details →

ArcPoint Labs 10 Panel Dip Screen (OXY), Item No. APD-10MO These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.

Ameditech

Class I - Dangerous

Ameditech is recalling drug abuse tests because they have shown reduced reactivity.

Oct 20, 2015 Diagnostic Equipment Nationwide View Details →

CIVCO Infiniti Plus Needle Guide, Sterile Needle Guide, 12-18GA, Rx ONLY, STERILE EO. REFs 610-1215, 610-1234, 610-1235, 610-1236. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.

Civco Medical Instruments Co.

Class I - Dangerous

Sterility of the product cannot be assured.

Oct 21, 2015 Diagnostic Equipment Nationwide View Details →