Reported Feb 21, 2018 · Terminated

A.T.S. 4000TS Tourniquet Systems, Personalized Pressure. Intended to be used by qualified professionals to temporarily…

Zimmer Surgical Inc.

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: Zimmer Surgical Inc · 200 W Ohio Ave · Dover, OH · 44622-9642

Is this the product you have?

A.T.S. 4000TS Tourniquet Systems, Personalized Pressure. Intended to be used by qualified professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities. .

Lot codes and dates: 152 of 152 products
Products covered by this recall
Model / number Barcodes Product as published
60400040400 —
— Lot No. 62510549 (Serial Numbers: 4013JAAA, 4013JAAB, 4013JAAC, 4013JAAD, 4013JAAE, 4013JAAF, 4013JAAG, 4013JAAH, 4013JAAJ, 4013JAAK, 4013JAAL, 4013JAAM, 4013JAAN, 4013JAAP, 4013JAAQ, 4013JAAR, 4013JAAS, 4013JAAT, 4013JAAU, 4013JAAW, 4013JABA, 4013JABB, 4013JABC, 4013JABD, 4013JABE, 4013JABF, 4013JABG)
— Lot No. 62510845 (Serial Numbers: 4013JABH, 4013JABJ, 4013JABK, 4013JABL, 4013JABM, 4013JABN, 4013JABP, 4013JABQ, 4013JABR, 4013JABS, 4013JABT, 4013JABU, 4013JABW, 4013JACA, 4013JACB, 4013JACC, 4013JACD, 4013JACE, 4013JACF, 4013JACG)
— Lot No. 62510927 (Serial Numbers: 4013JACH, 4013JACJ, 4013JACK, 4013JACL, 4013JACM, 4013JACN, 4013JACP, 4013JACQ, 4013JACR, 4013JACS, 4013JACT, 4013JACU, 4013JACW, 4013JADA, 4013JADB, 4013JADC, 4013JADD, 4013JADE, 4013JADF, 4013JADG)
— Lot No. 62510928 (Serial Numbers: 4013JADH, 4013JADJ, 4013JADK, 4013JADL, 4013JADM, 4013JADN, 4013JADP, 4013JADQ, 4013JADR, 4013JADS, 4013JADT, 4013JADU, 4013JADW, 4013JAEA, 4013JAEB, 4013JAEC, 4013JAED, 4013JAEE, 4013JAEF, 4013JAEG)
— Lot No. 62525817 (Serial Numbers: 4013KAAA, 4013KAAB, 4013KAAC, 4013KAAD, 4013KAAE, 4013KAAF, 4013KAAG, 4013KAAH, 4013KAAJ, 4013KAAK, 4013KAAL, 4013KAAM, 4013KAAN, 4013KAAP, 4013KAAQ, 4013KAAR, 4013KAAS, 4013KAAT, 4013KAAU, 4013KAAW)
— Lot No. 62525841 (Serial Numbers: 4013KABA, 4013KABB, 4013KABC, 4013KABD, 4013KABE, 4013KABF, 4013KABG, 4013KABH, 4013KABJ, 4013KABK, 4013KABL, 4013KABM, 4013KABN, 4013KABP, 4013KABQ, 4013KABR, 4013KABS, 4013KABT, 4013KABU, 4013KABW)
— Lot No. 62616141 (Serial Numbers: 4014BAAA, 4014BAAB, 4014BAAC, 4014BAAD, 4014BAAE, 4014BAAF, 4014BAAG, 4014BAAH, 4014BAAJ, 4014BAAK, 4014BAAL, 4014BAAM, 4014BAAN, 4014BAAP, 4014BAAQ, 4014BAAR, 4014BAAS, 4014BAAT, 4014BAAU, 4014BAAW)
— Lot No. 62616142 (Serial Numbers: 4014BABA, 4014BABB, 4014BABC, 4014BABD, 4014BABE, 4014BABF, 4014BABG, 4014BABH, 4014BABJ, 4014BABK, 4014BABL, 4014BABM, 4014BABN, 4014BABP, 4014BABQ, 4014BABR, 4014BABS, 4014BABT, 4014BABU, 4014BABW)
— Lot No. 62616143 (Serial Numbers: 4014BACA, 4014BACB, 4014BACC, 4014BACD, 4014BACE, 4014BACF, 4014BACG, 4014BACH, 4014BACJ, 4014BACK, 4014BACL, 4014BACM, 4014BACN, 4014BACP, 4014BACQ, 4014BACR, 4014BACS, 4014BACT, 4014BACU, 4014BACW)
— Lot No. 62616145 (Serial Number: 4014BADA, 4014BADB, 4014BADC, 4014BADD, 4014BADE, 4014BADF, 4014BADG, 4014BADH, 4014BADJ, 4014BADK, 4014BADL, 4014BADM, 4014BADN, 4014BADP, 4014BADQ, 4014BADR, 4014BADS, 4014BADT, 4014BADU, 4014BADW)
— Lot No. 62635795 (Serial Numbers: 4014CAAA, 4014CAAB, 4014CAAC, 4014CAAD, 4014CAAE, 4014CAAF, 4014CAAG, 4014CAAH, 4014CAAJ, 4014CAAK, 4014CAAL, 4014CAAM, 4014CAAN, 4014CAAP, 4014CAAQ, 4014CAAR, 4014CAAS, 4014CAAT, 4014CAAU, 4014CAAW)
— Lot No. 62635796 (Serial Numbers: 4014CABA, 4014CABB, 4014CABC, 4014CABD, 4014CABE, 4014CABF, 4014CABG, 4014CABH, 4014CABJ, 4014CABK, 4014CABL, 4014CABM, 4014CABN, 4014CABP, 4014CABQ, 4014CABR, 4014CABS, 4014CABT, 4014CABU, 4014CABW)
— Lot No. 62635797 (Serial Numbers: 4014CACA, 4014CACB, 4014CACC, 4014CACD, 4014CACE, 4014CACF, 4014CACG, 4014CACH, 4014CACJ, 4014CACK, 4014CACL, 4014CACM, 4014CACN, 4014CACP, 4014CACQ, 4014CACR, 4014CACS, 4014CACT, 4014CACU, 4014CACW)
— Lot No. 62642282 (Serial Numbers: 4014CADA, 4014CADB, 4014CADC, 4014CADD, 4014CADE, 4014CADF, 4014CADG, 4014CADH, 4014CADJ, 4014CADK, 4014CADL, 4014CADM, 4014CADN, 4014CADP, 4014CADQ, 4014CADR, 4014CADS, 4014CADT,4014CADU, 4014CADW)
— Lot No. 62635798 (Serial Numbers: 4014CAEA, 4014CAEB, 4014CAEC, 4014CAED, 4014CAEE, 4014CAEF, 4014CAEG, 4014CAEH, 4014CAEJ, 4014CAEK, 4014CAEL, 4014CAEM, 4014CAEN, 4014CAEP, 4014CAEQ, 4014CAER, 4014CAES, 4014CAET, 4014CAEU, 4014CAEW)
— Lot No. 62676173 (Serial Numbers: 4014DAAA, 4014DAAB, 4014DAAC, 4014DAAD, 4014DAAE, 4014DAAF, 4014DAAG, 4014DAAH, 4014DAAJ, 4014DAAK, 4014DAAL, 4014DAAM, 4014DAAN, 4014DAAP, 4014DAAQ, 4014DAAR, 4014DAAS, 4014DAAT, 4014DAAU, 4014DAAW)
— Lot No. 62676174 (Serial Numbers: 4014DABA, 4014DABB, 4014DABC, 4014DABD, 4014DABE, 4014DABF, 4014DABG, 4014DABH, 4014DABJ, 4014DABK, 4014DABL, 4014DABM, 4014DABN, 4014DABP, 4014DABQ, 4014DABR, 4014DABS, 4014DABT, 4014DABU, 4014DABW)
— Lot No. 62686165 (Serial Numbers: 4014DACA, 4014DACB, 4014DACC, 4014DACD, 4014DACE, 4014DACF, 4014DACG, 4014DACH, 4014DACJ, 4014DACK, 4014DACL, 4014DACM, 4014DACN, 4014DACP, 4014DACQ, 4014DACR, 4014DACS, 4014DACT, 4014DACU, 4014DACW)
— Lot No. 62686166 (Serial No. 4014DADA, 4014DADB, 4014DADC, 4014DADD, 4014DADE, 4014DADF, 4014DADG, 4014DADH, 4014DADJ, 4014DADK, 4014DADL, 4014DADM, 4014DADN, 4014DADP, 4014DADQ, 4014DADR, 4014DADS, 4014DADT, 4014DADU, 4014DADW)
Page 1 of 8
Amount recalled: 8,231 devices total

This recall covers 2 products

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

A.T.S. 2200TS Tourniquet Systems, Personalized Pressure. Zimmer Surgical, Inc. Dover…

Where it was sold

Why it was recalled

Updated on-device label and 3 pages of an updated Operator/Service Manual. Also, decrease from 3.8 meters (m) to 1.0 separation distance between the device and RF communication equipment.

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

Want the full recall guide?

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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By hazard

Medical device recalls

Other recalls from Zimmer Surgical Inc.

Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems… Jul 8, 2026
Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 5000TS Tourniquet Systems… Feb 4, 2026
Zimmer Air Dermatome, Model/ Dec 24, 2025
3:1 Dermacarrier, Model Number 00219501300, skin graft carrier Feb 21, 2024
Zimmer Dermatome Blades- 10-pack boxes of blades. Intended for use with the dermatome… Oct 11, 2023
Zimmer Sterile Disposable Tourniquet Cuff with Protective Sleeve and PLC, Dual Port… Mar 4, 2020

14 in total.

Where it was distributed

All recall categories · Browse the whole archive

Model / number	Barcodes	Product as published
`60400040400`		—
—		Lot No. 62510549 (Serial Numbers: 4013JAAA, 4013JAAB, 4013JAAC, 4013JAAD, 4013JAAE, 4013JAAF, 4013JAAG, 4013JAAH, 4013JAAJ, 4013JAAK, 4013JAAL, 4013JAAM, 4013JAAN, 4013JAAP, 4013JAAQ, 4013JAAR, 4013JAAS, 4013JAAT, 4013JAAU, 4013JAAW, 4013JABA, 4013JABB, 4013JABC, 4013JABD, 4013JABE, 4013JABF, 4013JABG)
—		Lot No. 62510845 (Serial Numbers: 4013JABH, 4013JABJ, 4013JABK, 4013JABL, 4013JABM, 4013JABN, 4013JABP, 4013JABQ, 4013JABR, 4013JABS, 4013JABT, 4013JABU, 4013JABW, 4013JACA, 4013JACB, 4013JACC, 4013JACD, 4013JACE, 4013JACF, 4013JACG)
—		Lot No. 62510927 (Serial Numbers: 4013JACH, 4013JACJ, 4013JACK, 4013JACL, 4013JACM, 4013JACN, 4013JACP, 4013JACQ, 4013JACR, 4013JACS, 4013JACT, 4013JACU, 4013JACW, 4013JADA, 4013JADB, 4013JADC, 4013JADD, 4013JADE, 4013JADF, 4013JADG)
—		Lot No. 62510928 (Serial Numbers: 4013JADH, 4013JADJ, 4013JADK, 4013JADL, 4013JADM, 4013JADN, 4013JADP, 4013JADQ, 4013JADR, 4013JADS, 4013JADT, 4013JADU, 4013JADW, 4013JAEA, 4013JAEB, 4013JAEC, 4013JAED, 4013JAEE, 4013JAEF, 4013JAEG)
—		Lot No. 62525817 (Serial Numbers: 4013KAAA, 4013KAAB, 4013KAAC, 4013KAAD, 4013KAAE, 4013KAAF, 4013KAAG, 4013KAAH, 4013KAAJ, 4013KAAK, 4013KAAL, 4013KAAM, 4013KAAN, 4013KAAP, 4013KAAQ, 4013KAAR, 4013KAAS, 4013KAAT, 4013KAAU, 4013KAAW)
—		Lot No. 62525841 (Serial Numbers: 4013KABA, 4013KABB, 4013KABC, 4013KABD, 4013KABE, 4013KABF, 4013KABG, 4013KABH, 4013KABJ, 4013KABK, 4013KABL, 4013KABM, 4013KABN, 4013KABP, 4013KABQ, 4013KABR, 4013KABS, 4013KABT, 4013KABU, 4013KABW)
—		Lot No. 62616141 (Serial Numbers: 4014BAAA, 4014BAAB, 4014BAAC, 4014BAAD, 4014BAAE, 4014BAAF, 4014BAAG, 4014BAAH, 4014BAAJ, 4014BAAK, 4014BAAL, 4014BAAM, 4014BAAN, 4014BAAP, 4014BAAQ, 4014BAAR, 4014BAAS, 4014BAAT, 4014BAAU, 4014BAAW)
—		Lot No. 62616142 (Serial Numbers: 4014BABA, 4014BABB, 4014BABC, 4014BABD, 4014BABE, 4014BABF, 4014BABG, 4014BABH, 4014BABJ, 4014BABK, 4014BABL, 4014BABM, 4014BABN, 4014BABP, 4014BABQ, 4014BABR, 4014BABS, 4014BABT, 4014BABU, 4014BABW)
—		Lot No. 62616143 (Serial Numbers: 4014BACA, 4014BACB, 4014BACC, 4014BACD, 4014BACE, 4014BACF, 4014BACG, 4014BACH, 4014BACJ, 4014BACK, 4014BACL, 4014BACM, 4014BACN, 4014BACP, 4014BACQ, 4014BACR, 4014BACS, 4014BACT, 4014BACU, 4014BACW)
—		Lot No. 62616145 (Serial Number: 4014BADA, 4014BADB, 4014BADC, 4014BADD, 4014BADE, 4014BADF, 4014BADG, 4014BADH, 4014BADJ, 4014BADK, 4014BADL, 4014BADM, 4014BADN, 4014BADP, 4014BADQ, 4014BADR, 4014BADS, 4014BADT, 4014BADU, 4014BADW)
—		Lot No. 62635795 (Serial Numbers: 4014CAAA, 4014CAAB, 4014CAAC, 4014CAAD, 4014CAAE, 4014CAAF, 4014CAAG, 4014CAAH, 4014CAAJ, 4014CAAK, 4014CAAL, 4014CAAM, 4014CAAN, 4014CAAP, 4014CAAQ, 4014CAAR, 4014CAAS, 4014CAAT, 4014CAAU, 4014CAAW)
—		Lot No. 62635796 (Serial Numbers: 4014CABA, 4014CABB, 4014CABC, 4014CABD, 4014CABE, 4014CABF, 4014CABG, 4014CABH, 4014CABJ, 4014CABK, 4014CABL, 4014CABM, 4014CABN, 4014CABP, 4014CABQ, 4014CABR, 4014CABS, 4014CABT, 4014CABU, 4014CABW)
—		Lot No. 62635797 (Serial Numbers: 4014CACA, 4014CACB, 4014CACC, 4014CACD, 4014CACE, 4014CACF, 4014CACG, 4014CACH, 4014CACJ, 4014CACK, 4014CACL, 4014CACM, 4014CACN, 4014CACP, 4014CACQ, 4014CACR, 4014CACS, 4014CACT, 4014CACU, 4014CACW)
—		Lot No. 62642282 (Serial Numbers: 4014CADA, 4014CADB, 4014CADC, 4014CADD, 4014CADE, 4014CADF, 4014CADG, 4014CADH, 4014CADJ, 4014CADK, 4014CADL, 4014CADM, 4014CADN, 4014CADP, 4014CADQ, 4014CADR, 4014CADS, 4014CADT,4014CADU, 4014CADW)
—		Lot No. 62635798 (Serial Numbers: 4014CAEA, 4014CAEB, 4014CAEC, 4014CAED, 4014CAEE, 4014CAEF, 4014CAEG, 4014CAEH, 4014CAEJ, 4014CAEK, 4014CAEL, 4014CAEM, 4014CAEN, 4014CAEP, 4014CAEQ, 4014CAER, 4014CAES, 4014CAET, 4014CAEU, 4014CAEW)
—		Lot No. 62676173 (Serial Numbers: 4014DAAA, 4014DAAB, 4014DAAC, 4014DAAD, 4014DAAE, 4014DAAF, 4014DAAG, 4014DAAH, 4014DAAJ, 4014DAAK, 4014DAAL, 4014DAAM, 4014DAAN, 4014DAAP, 4014DAAQ, 4014DAAR, 4014DAAS, 4014DAAT, 4014DAAU, 4014DAAW)
—		Lot No. 62676174 (Serial Numbers: 4014DABA, 4014DABB, 4014DABC, 4014DABD, 4014DABE, 4014DABF, 4014DABG, 4014DABH, 4014DABJ, 4014DABK, 4014DABL, 4014DABM, 4014DABN, 4014DABP, 4014DABQ, 4014DABR, 4014DABS, 4014DABT, 4014DABU, 4014DABW)
—		Lot No. 62686165 (Serial Numbers: 4014DACA, 4014DACB, 4014DACC, 4014DACD, 4014DACE, 4014DACF, 4014DACG, 4014DACH, 4014DACJ, 4014DACK, 4014DACL, 4014DACM, 4014DACN, 4014DACP, 4014DACQ, 4014DACR, 4014DACS, 4014DACT, 4014DACU, 4014DACW)
—		Lot No. 62686166 (Serial No. 4014DADA, 4014DADB, 4014DADC, 4014DADD, 4014DADE, 4014DADF, 4014DADG, 4014DADH, 4014DADJ, 4014DADK, 4014DADL, 4014DADM, 4014DADN, 4014DADP, 4014DADQ, 4014DADR, 4014DADS, 4014DADT, 4014DADU, 4014DADW)